Criterion-related validity of the International Physical Activity Questionnaire (IPAQ) in gastrointestinal cancer patients receiving outpatient chemotherapy

doi:10.21203/rs.3.rs-2204707/v1

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Criterion-related validity of the International Physical Activity Questionnaire (IPAQ) in gastrointestinal cancer patients receiving outpatient chemotherapy

https://doi.org/10.21203/rs.3.rs-2204707/v1

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Purpose

To investigate the criterion-related validity of the International Physical Activity Questionnaire (IPAQ) in gastrointestinal cancer patients undergoing outpatient chemotherapy.

Methods

The subjects were gastrointestinal cancer patients receiving outpatient chemotherapy. The correlations of daily activity energy expenditure (AEE) according to the IPAQ-Short-Form(IPAQ-SF), daily AEE with an activity monitor, and energy expenditure from walking were analyzed.

Results

The subjects were 50 people with a mean age of 65.6±10.5 years. The median daily AEE was 86.0 kcal with the IPAQ-SF and 374.0 kcal with the activity monitor, with no correlation between the two. The median daily energy expenditure from walking was 84.3 kcal with the IPAQ-SF and 82.3 kcal with the activity monitor, with a significant correlation (r=0.378) between the two. With a one-week chemotherapy administration interval, significant correlations were seen with daily AEE (r=0.766) and energy expenditure from walking (r=0.888), but no significant correlations were seen with intervals of two weeks or longer.

Conclusions

Using the IPAQ-SF in measurements of energy expenditure from walking during chemotherapy was found to be valid. With respect to AEE, however, when using the IPAQ-SF, it is necessary to evaluate the amount of activity for the most recent week, not a usual week.

Implications for cancer survivors

This study verified the validity of the IPAQ-SF as a screening tool to simply assess physical activity (PA) during outpatient chemotherapy. Implementation of evaluations of PA may facilitate the maintenance of daily exercise habits and assure PA, and improve the continuation of therapy and prolong survival.

Anti-cancer drug

Physical fitness

energy expenditure

activity monitor

Indications for cancer drug therapy are generally determined based on the Eastern Cooperative Oncology Group Performance Status [1] (ECOG-PS). PS is a simple indicator of physical activity (PA) shown in 5 levels of 0–4. Studies of gastrointestinal cancer patients receiving chemotherapy [2, 3] have shown that people with poor PS have low chemotherapy completion rates and are more susceptible to serious side effects, and that poor PS is related to life expectancy [4]. Maintaining regular exercise habits and ensuring PA even during therapy is important for prolonging survival. In elderly cancer patients, restrictions on activities of daily living (ADL) may occur due to aging or comorbidities, and PA is likely to decrease. Accurate assessments of the level and changes in PA are necessary in implementing cancer drug therapy. Therefore, evaluations of PA that are more detailed than the five levels of PS are necessary.

Standard methods of evaluating PA are to find the relative metabolic rate (RMR) by type of movement based on indirect calorimetry or the activity energy expenditure (AEE) based on PA from calculation of the metabolic equivalent of a task (MET) [5, 6]. With these methods, however, it is difficult to evaluate daily PA at home, and so methods used in clinical settings include questionnaires or calculation of AEE by wearing an activity monitor.

Evaluations can be easily done with questionnaires, but there is a possibility of recall bias due to the ambiguities of memory. The International Physical Activity Questionnaire (IPAQ) [5] is representative of these questionnaires. Psychometric analyses done with the IPAQ in healthy adults and healthy elderly adults have verified it to be an evaluation with superior reliability and validity [5–7]. At the same time, in an evaluation with the IPAQ of 91 cancer patients of various disease stages aged 18–80 years [8], a tendency was shown for the patients to have sedentary lives with almost no moderate or vigorous PA. However, a psychometric analysis was not performed. Therefore, the differences in administration depending on the drug and the onset time of adverse events that affect PA need to be considered in cancer patients undergoing outpatient chemotherapy. It is unclear whether activity levels can be accurately evaluated with the IPAQ for the evaluation of PA in cancer patients undergoing chemotherapy. With activity monitors, on the other hand, highly precise measurements are obtained [5–7], and the correlation with indirect calorimetry is also high [9], but the psychological burden of wearing one every day and the difficulty of continuation are problems. Both methods have advantages and disadvantages, and so they need to be selected for use with consideration of the characteristics of each method based on the clinical setting.

The purpose of this study was to verify the criterion-related validity of the IPAQ-SF by comparing the daily AEE calculated with the IPAQ-Short-Form (IPAQ-SF) with the daily AEE recorded with an activity monitor in gastrointestinal cancer patients undergoing outpatient chemotherapy.

Study design

This was a prospective, observational study.

Subjects

The subjects were gastrointestinal cancer patients who received outpatient chemotherapy at Keio University Hospital Cancer Center between July 10 and December 5, 2018, excluding patients with bone metastasis, dementia, and those who were unable to walk.

Basic Information, Medical Information

The researchers collected information including subject age, sex, height, weight, and body mass index (BMI) as basic information, and name of the disease, occupation, cancer stage [10], anti-cancer drug administered, number of days since the start of the anti-cancer drug, and status of anti-cancer drug therapy as medical information from electronic medical records. Adverse events (general malaise, hand-foot syndrome, poor appetite, limb numbness, nausea, pain, diarrhea, constipation) were written down by the subjects before going to bed each night, and the researchers checked the status of their entries on the day of the interview. Based on this, an evaluation was done using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, Japanese translation, JCOG version [11]. General status was evaluated using ECOG-PS.

Primary Endpoints

The primary endpoints were daily AEE calculated from the IPAQ-SF and daily AEE recorded by an activity monitor (Active Style Pro HJA750-C; Omron Healthcare Co., Ltd., Kyoto, Japan). Concerning the IPAQ-SF, in-person interviews were conducted the day after subjects stopped wearing the activity monitor (the day of the next anti-cancer drug administration), and PA in a usual week was evaluated. On the other hand, how to attach the activity monitor was explained to patients on the day of an outpatient visit for anti-cancer drug treatment, and they began wearing the monitor from that day (Day 1). They continued wearing the activity monitor until going to bed the day before the next anti-cancer drug administration. There were four intervals between anti-cancer drug administrations: one week (Day 7), two weeks (Day 14), three weeks (Day 21), and four weeks (Day 28).

The IPAQ-SF is a questionnaire that calculates total physical activity (TPA) from the amounts of high-intensity PA (mins), moderate PA (mins), walking time (mins) per week, and the number of days of each [5, 6]. The unit of the exercise was taken to be Mets, with high-intensity PA equivalent to 8.0 Mets, moderate PA 4.0 Mets, and walking 3.3 Mets. PA (unit: Mets/min) was calculated from exercise intensity (Mets) × time (mins) × no. of days. High-intensity PA, moderate PA, and walking PA were totaled to calculate TPA. AEE was calculated from TPA × 3.5 × 0.005 × body weight (kg) and divided by 7 to calculate the energy expenditure (unit: kcal) per day. In this study, the researchers calculated these values after interviewing patients once for about 20 minutes. The IPAQ-SF uses two ways to ask about the amount of activity per week: the amount of activity in a “usual week” and the amount of activity in the “last 7 days” [5]. In the present study, the amount of activity in a “usual week” was used.

The Active Style Pro activity monitor captures changes in body movement and posture using three-dimensional (three-axis) acceleration sensors and unique signal processing. It identifies walking and daily living activities by identifying various actions and measures PA. It can also calculate, for example, arm movements such as in cleaning or doing laundry and low activity levels (sitting) [12, 13]. With the Active Style Pro HJA750-C, a strap is passed through the body of the monitor, which is set in a holder worn on the hip with a clip system. After the monitor is fixed in place with a clip on a belt or clothes, the strap is tied to the belt or belt loop to prevent it from falling [10, 13]. The Active Style Pro HJA750-C can measure activity periods from 1.0 Mets to ≥ 8.0 Mets (up to 18.0 Mets) and energy expenditure. It also records Mets every 10 sec and 60 sec, and records energy expenditure from PA and the number of steps every hour.

Statistical Analyses

Correlations of daily AEE calculated from the IPAQ-SF, daily AEE recorded by the activity monitor, and energy expenditure from walking were analyzed using Spearman’s rank correlation coefficients. Similar analyses were also performed for each anti-cancer drug administration interval week.

IBM SPSS Statistics 25 (IBM Japan, Ltd., Tokyo, Japan) was used in the statistical analysis, with < 5% taken to indicate significance.

Ethical Considerations

This study was approved by the Keio University School of Medicine ethics committee (approval no. 2018-0053).

Basic information and medical information

Fifty people were enrolled. They included 33 men and 17 women, with a mean age of 65.6 ± 10.5 years (men: 66.9 ± 9.8 years, women: 63.2 ± 11.7 years). Mean BMI was 21.3 ± 3.1 kg/m² (men: 21.9 ± 3.0 kg/m², women: 20.2 ± 3.2 kg/m²). Occupational status was full-time work for 12 people, part-time work for 7, on leave for 6, and unemployed for 25. PS was PS 0 for 45 people and PS 1 for 5.

The primary cancer was esophageal cancer for 1 person, gastroesophageal junction cancer for 1, gastric cancer for 16, colon cancer for 19, pancreatic cancer for 8, bile duct cancer for 1, neuroendocrine tumor for 1, and gastrointestinal stromal tumor for 3. The cancer stage was stage 4 for 37 people and relapse for 13.

The anti-cancer drug treatment schedule was first-line treatment for 23 people, second-line treatment for 19, third-line treatment for 3, fourth-line treatment for 3, fifth-line treatment for 1, and salvage line therapy for 1. The anti-cancer drug administration interval was one week for 10 people, two weeks for 20, three weeks for 17, and four weeks for 1. Two people dropped out for hospitalization.

The anti-cancer drug administered on the day of the IPAQ-SF interview, for the cumulative total number of people, was 5FU-based therapy for 28 people, platinum-based agents for 21 people, taxanes for 13 people, irinotecan for 7 people, molecular-targeted agents for 29 people, and gemcitabine for 8 people. The median number of days from the start of the first anti-cancer drug administration until the activity monitor collection day (IPAQ-SF interview day) was 412 (minimum 14 days, maximum 1,655 days; calculated with 44 people, excluding 6 in whom the number was unknown). The median number of days from the starting date of the anti-cancer drug administered on the day of the IPAQ-SF interview until the activity monitor collection day (IPAQ-SF interview day) was 151 (minimum 14 days, maximum 918 days; calculated with 47 people excluding 3 in whom the number was unknown).

Adverse events of Grade 3 or higher during the time subjects were wearing the activity monitor were loss of appetite in 5 people, pain in 5, limb numbness in 2, nausea in 2, diarrhea in 2, general malaise in 1, hand-foot syndrome in 1, and constipation in 0.

Aee With The Ipaq-sf And The Activity Monitor

Forty-seven of 50 people completed the study. The reason for the missing values for three people was hospitalization (two people) and deletion of data as a result of error during data output from the activity monitor (1 person). The median daily AEE with the IPAQ-SF was 86.0 kcal (minimum 0 kcal–maximum 3,706 kcal). The median value with the activity monitor was 374.0 kcal (minimum 6 kcal–maximum 700 kcal). No significant correlation of the daily AEE with the IPAQ-SF and the activity monitor (r = 0.255, P = 0.087) was seen.

Calorie expenditure from walking with the IPAQ-SF and the activity monitor

The median daily calorie expenditure from walking according to the IPAQ-SF was 84.3 kcal (minimum 0 kcal–maximum 367.3 kcal), and the median value with the activity monitor was 82.3 kcal (minimum 3 kcal–maximum 422.5 kcal). A significant correlation was seen in energy expenditure from walking recorded by the IPAQ-SF and the activity monitor (r = 0.378, P = 0.010).

Effects of the anti-cancer drug administration interval

The AEE recorded from the IPAQ-SF and the activity monitor, calories consumed in walking, and the correlations between them are shown in Table 1 for each anti-cancer drug administration interval. With a one-week administration interval, a significant correlation was seen in daily AEE and energy expenditure from walking. With two-week and three-week administration intervals, no significant correlations were seen. Only one person had a four-week administration interval and was therefore excluded from the analysis.

Table 1

Spearman correlation coefficients between the IPAQ-SF and activity energy expenditure (AEE) and walking recorded by the Active style Pro HJA750-C by the duration of treatment
Duration of treatment (n)	Evaluation items of the IPAQ-SF	Median (kcal/day)		Spearman correlation coefficient	P-value
Duration of treatment (n)	Evaluation items of the IPAQ-SF	IPAQ-SF	Active style Pro HJA750-C	Spearman correlation coefficient	P-value
1 week (10)	AEE (Vigorous + moderate + Walking) (kcal/day)	71.5	363.5	0.766	0.010^*
1 week (10)	Walking (kcal/day)	50.6	74.0	0.888	0.001^*
2 weeks (20)	AEE (Vigorous + moderate + Walking) (kcal/day)	109	405	-0.072	0.770
2 weeks (20)	Walking (kcal/day)	106.2	108	0.168	0.491
3 weeks (17)	AEE (Vigorous + moderate + Walking) (kcal/day)	46.0	355.5	0.339	0.199
3 weeks (17)	Walking (kcal/day)	45.6	61.0	0.357	0.175
*: P < 0.05

Methods of evaluating PA in cancer patients receiving outpatient chemotherapy

Questionnaires are often used in clinical settings for their convenience in quantitatively evaluating PA at home. Psychometric analyses have been done in healthy subjects with the IPAQ and Seven-day Physical Activity Recall (7-Day PAR) [14], which are widely used internationally, and they have been verified to be evaluation methods with superior reliability and validity. However, in evaluations of PA in cancer patients receiving outpatient chemotherapy, it remains unclear whether activity levels can be more accurately evaluated with the IPAQ.

In this study, the IPAQ-SF, which has fewer evaluation items than the 7-Day PAR, was used to alleviate the time constraints and patient burden of conducting a survey between outpatient visits. The IPAQ has short-form (IPAQ-SF) and long-form (IPAQ-LF) versions. The IPAQ-SF consists of a total of 9 questions by intensity level of PA, whereas the IPAQ-LF consists of a total of 31 questions by intensity level related to daily living situations including work, traveling, at home, and leisure time [5, 6]. No obvious differences are seen between the two in terms of reliability and validity, and so the IPAQ-SF with fewer question items is often used in actual surveys. The IPAQ-SF was used in the present study as well. The reason for using the amount of activity in a “usual week” was that the administration duration of the anti-cancer drugs for the subjects in this study varied among one week, two weeks, three weeks, and four weeks. If the amount of activity in the “last 7 days” had been used, the responses of patients with treatment durations of two or more weeks in particular would correspond only to the final week of the treatment period, and the first week would not be considered. Adverse events sometimes occur soon after administration, and it was thought that using the amount of activity in a “usual week” was appropriate for investigating the entire treatment period.

Highly precise records of daily PA are possible with the use of an activity monitor [5–7], but there are drawbacks, in that an activity monitor needs to be purchased, attaching the monitor is a mental burden, wearing one involves much self-management, and guaranteeing continuation is difficult. In the present study, after collecting the activity monitors, graphs were created of the daily amount of activity and number of steps during the period when they were worn. They were then returned to the individual patients, and it was explained to each person that activity is presented and could be understood in this way. This was done to raise adherence, and nearly all subjects completed the trial wearing the monitor every day.

The Active Style Pro HJA750-C activity monitor used in this study records every 10 sec, and intensity can be calculated not only in the vertical direction (1 axis), but three-dimensionally (3 axes). In a report with healthy adult subjects (21–50 years old), the validity of several activity monitors including the Active Style Pro HJA750-C was compared with values measured by indirect calorimetry in a metabolic chamber, and total energy expenditure (TEE) per day was compared with measured values from the Active Style Pro HJA750-C together with indirect calorimetry and the doubly labelled water method. Error for each was held to within 10%, and approximate values were shown [9]. Accurate measurements can sometimes not be made when the body of the device is not perpendicular to the ground surface (inclinations of less than 30° in the sagittal and coronal planes are not a problem), when it is used during motions accompanied by up and down movement or in places where there is much vibration (when it is in a bag, when it is hung around the neck or on the hips, when there is up-down vibration from ascending or descending stairs or steep slopes or riding a vehicle (bicycle, automobile, train, bus, etc.), when the person is performing training exercises centered on the upper body, or when jogging or walking very slowly (Mets can be measured)) [9]. Although there are limitations in attaching it as a wearable device, measured values similar to those with indirect calorimetry are obtained, and it is thus thought to be useful in actual clinical settings or clinical research.

Differences In Aee Between The Ipaq-sf And The Activity Monitor

In a report by Murase et al. [6], the mean daily AEE in 125 healthy Japanese adults (mean age males 36.8 ± 10.6 years, females 32.0 ± 9.2 years) was 226 kcal with the IPAQ-SF and 297 kcal with an activity monitor (Lifecorder). There was no major difference in daily AEE with the IPAQ-SF and the activity monitor, and a significant correlation was seen. In the present study, the median daily AEE was 86.0 kcal with the IPAQ-SF and 374 Kcal with the activity monitor (Active Style Pro). There was a large difference in daily AEE with the IPAQ-SF and the activity monitor, and no correlation was seen.

An exact comparison is difficult because of differences in subjects, their ages, and the number of cases, but even though Murase et al. [6] included activity amounts below the moderate level in the energy expenditure with the Lifecorder, a significant correlation was obtained with the energy expenditure calculated from the IPAQ-SF, and they considered that overall PA could be evaluated with the IPAQ-SF, which has limited questions on PA of moderate or above levels. The question content on moderate PA on the IPAQ-SF includes carrying light packages and leisure activities such as playing tag with children, slow swimming, doubles tennis, and playing golf without using a cart. In the report by Murase et al. [6], the employment rate was higher than 80%, and it is conjectured that, unlike the subjects in the present study who took time off from work, housework, and leisure activities and refrained from going out while undergoing treatment, the subjects in that study lived comparatively regular lives for the week, including leisure time, as well as work. In contrast, the subjects in the present study were patients receiving chemotherapy, and they tended to sit more and have more low intensity PA than healthy people. Thus, it is thought that errors were more likely to occur with the IPAQ-SF, which has limited questions on moderate or higher levels of PA. From the fact that responses on moderate activity included “not including slow or fast walking” and “respond only for activities continued for at least 10 minutes” [6], if the subjects of the present study actually walked at a rate equivalent to moderate activity for less than 10 minutes, it may not have been reflected in the results [7].

Differences Between The Ipaq-sf And The Activity Monitor In Energy Expenditure From Walking

In this study, energy expenditure from walking was nearly the same with the IPAQ-SF and the activity monitor, and a significant correlation was seen, with a correlation coefficient of 0.378. In a study that analyzed the walking data for healthy people (18–65 years old) in the nine countries involved in developing the IPAQ-SF [15], it was reported that a significant but weak correlation, with a correlation coefficient of 0.26, was seen between walking time obtained with an accelerometer and walking time obtained with the IPAQ-SF. Even a report that investigated the validity of using the IPAQ-SF with healthy older adults [7] showed a significant correlation. Compared with AEE, walking involves clear movements, and therefore records and responses may be more accurate.

Effects Of Anti-cancer Drug Administration Interval

In the present study, high correlations were seen with both AEE measured with the IPAQ-SF and the activity monitor and energy expenditure from walking when the anti-cancer drug was administered at an interval of one week. On the other hand, in groups with administration intervals of two or three weeks, the differences between the IPAQ-SF and the activity monitor were large, and no correlation was seen. The reason for the underreporting in this study may be that, while the group with one-week intervals only looked back to the most recent corresponding week, the groups with two- or three-week intervals also considered the timing of the occurrence of adverse events from chemotherapy, and they had to search their memories to respond for a “usual week,” and these responses may have been inaccurate. In addition, with regard to adverse events from chemotherapy that affect PA, there are reports that heavy fatigue affects PA [16], and that patients who did not report heartburn, chest pain, or other pain spend much time engaged in light physical activity and do not spend a lot of time sitting [8]. It is conjectured that many of the patients in this study had lower levels of activity than usual and took time off from work and housework and refrained from going out for several days to about one week after receiving chemotherapy. The longer the interval between administrations, the larger the change in PA by the week. Responding about a “usual week” is difficult, and it could have led to underreporting. In past studies as well, it is reported that a reason for underreporting on the IPAQ-SF is that subjects were only asked to report activity performed for 10 minutes or more, and so activities done for less than 10 minutes were not reflected, whereas, in contrast, there is reported to be a tendency for overreporting with regard to activities that are considered to be socially desirable [7, 17].

Study Limitations And Future Outlook

The advantages of using the IPAQ-SF in gastrointestinal cancer patients receiving outpatient chemotherapy are that equipment does not have to be managed, the IPAQ-SF can be easily used, and data management is simple. From the results of the present study, the fact that a correlation was seen for walking showed that use of the IPAQ-SF is valid in understanding and managing the walking status of cancer patients undergoing chemotherapy. With regard to daily AEE, on the other hand, it was suggested that, when using the IPAQ-SF in patients with an anti-cancer drug administration interval of two weeks or more, the amount of activity in the most recent week, not a usual week, needs to be evaluated. In the future, it will be necessary to investigate validity when the IPAQ-SF is evaluated with the “last 7 days” in patients with anti-cancer drug administration intervals of two weeks or more.

In actual clinical settings, evaluation with the IPAQ-SF is simple, and thus using it as a screening tool for AEE and walking status in cancer patients undergoing chemotherapy is valid. However, the findings here suggest that modifications are needed in how the evaluation is done.

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

Competing Interests

The authors have no relevant financial or non-financial interests to disclose.

Author Contributions

All authors contributed to the study conception and design. The first draft of the manuscript was written by Iwakoshi M and all authors commented on subsequent versions of the manuscript. All authors read and approved the final manuscript. Conceptualization: Iwakoshi M, Tsuji T, Liu M. Data collection and analysis: Iwakoshi M, Tsuji T, Takaishi H. Writing- Reviewing and editing: Iwakoshi M, Tsuji T, Takaishi H, Hamamoto Y, Sukawa Y, Hirata K, Muraoka K. Supervision: Tsuji T, Liu M.

Data Availability

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Ethics approval

This study was approved by the Keio University School of Medicine ethics committee (approval no. 2018-0053).

Consent to participate

Informed consent was obtained from all individual participants included in the study.

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No competing interests reported.

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Version 1

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You are reading this latest preprint version

Criterion-related validity of the International Physical Activity Questionnaire (IPAQ) in gastrointestinal cancer patients receiving outpatient chemotherapy

Status:

Version 1

Abstract

Introduction

Methods

Study design

Subjects

Basic Information, Medical Information

Primary Endpoints

Statistical Analyses

Ethical Considerations

Results

Basic information and medical information

Aee With The Ipaq-sf And The Activity Monitor

Calorie expenditure from walking with the IPAQ-SF and the activity monitor

Effects of the anti-cancer drug administration interval

Discussion

Methods of evaluating PA in cancer patients receiving outpatient chemotherapy

Differences In Aee Between The Ipaq-sf And The Activity Monitor

Differences Between The Ipaq-sf And The Activity Monitor In Energy Expenditure From Walking

Effects Of Anti-cancer Drug Administration Interval

Study Limitations And Future Outlook

Statements And Declarations

References

Additional Declarations

Status:

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