Study design
This is a protocol for a pragmatic randomized controlled clinical trial. Pragmatic trials are used to evaluate the effectiveness of interventions in the actual clinical practice setting. This design maximizes the application and generalization of results by establishing an appropriate basis for decision-making.40,41 This study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement.42 Additional file 1 details the SPIRIT checklist.
Setting and Participants
Participants will be recruited from the waiting list for outpatient physical therapy of the Municipal Health Secretariat of Belo Horizonte, Brazil. All individuals on this list aged ≥ 60 years and referred to physical therapy after hospital discharge will be contacted by telephone for an initial survey to determine whether they fit the inclusion criteria with questions on mobility, cognition, and internet access. At an in-person meeting, the researchers will detail the study and clarify any questions. The participant will then be asked to sign the consent form and will undergo the initial evaluation. Figure 1 details the study planning.
The inclusion criteria are: 1) older adults age ≥ 60 years;43 2) being in a waiting list for outpatient physical therapy in the public healthcare system for any specific medical condition; 3) have recently been discharged from the hospital; 4) no impediment to unload weight in the lower limbs to perform the telerehabilitation program; 5) walking independently or with the aid of a device and being able to sit and stand up from a chair to perform physical function tests; 6) being in a stable clinical condition to avoid complications during the telerehabilitation program; 7) having a smartphone device with internet access (their own or a companion’s) for the telerehabilitation intervention; 8) having a companion during the execution of the exercises at home to ensure the safety of the intervention.
The exclusion criteria are: 1) presence of clinical complications that make physical exercise impossible; 2) neurological disease, such as Parkinson or stroke; 3) a score in the Mini-Mental State Exam less than 13 for people with no schooling, 18 for individuals with low/moderate schooling, and 26 for people with a high level of schooling;44 4) not being able to understand instructions or complete the tests. Excluded individuals will receive a booklet on the importance of staying active while awaiting physical therapy.
Randomization and allocation
After the initial evaluation, participants will be randomly allocated to the following groups: telerehabilitation (TG) and control (CG). The allocation will be in random blocks sizing four and six, with an allocation rate of 1:1. The randomized sequence will be computer-generated before the start of the study by a researcher not involved in the study and placed in opaque, sealed, sequentially numbered envelopes. This sequence will remain concealed until the participant is allocated to the groups.
Telerehabilitation intervention
The TG will receive a multi-component intervention that includes resistance exercises targeting the main muscle groups of the lower and upper limbs, and balance exercises. There are strong recommendations for the use of this type of intervention, showing improvement in clinical outcomes in older adults, such as reducing falls and increasing muscle strength and mobility.2,17,18,19,20,45 These exercises are easy to perform, do not require special equipment or accessories, and were designed for execution without professional supervision. In addition, the participant will choose an activity from their daily routine that they have difficulty in performing and hope to improve in the short term. The participants’ choosing an activity is a strategy aimed to stimulate engagement in the intervention and increase of their independence.
The exercise program will be carried out three to five times a week with high intensity, as suggested by Falvey et al. (2015).2 The volume will have three series; the number of repetitions will be customized based on Borg's Modified Perceived Exertion Scale,46 with effort level ranging from five to seven. The exercises’ difficulty levels and their sublevels of progression are shown in Table 1 and Additional file 2. Each participant may carry out the entire exercise program once a day or intermittently, two or three times a day.
The exercises will be available in a smartphone app developed for this study. This technology is widely used, being the main form of Internet access.47 The app will be installed on either the participant’s or the companion’s smartphone. After each exercise, the participants will report their level of pain and difficulty on the app, on a scale of 0 to 5. The exercise program may also be accessed via a computer if the participant prefers this device. After the initial evaluation, participants and their companion will be trained in how to use the app and perform the exercises. Information on deconditioning and the benefits of the proposed exercises will also be provided.
Two previously trained physical therapists who have a master’s degree will be responsible for monitoring the intervention. The proposed exercises and activities will be performed at home, in the presence of a companion to increase the safety of the exercises and facilitate the management of the app. Participants will be monitored by telephone and in-person meetings. The phone calls will take place weekly to monitor the exercises execution, pain, and adverse events. The progression of the exercises’ difficulty through the protocol’s sublevels will be based on this information, as well as those reported daily in the app. The face-to-face meetings will occur monthly (between 24-30 days) at the participant's rehabilitation center. In these meetings, the professionals will evaluate the execution of the exercises and adjust the difficulty level according to the participant's performance. The intervention will cease when the participant is contacted to begin outpatient physical therapy. Therefore, the participation period in the trial will depend on the waiting time of each participant.
Control group
CG participants will follow the usual flow of the waiting list of patients awaiting outpatient physical therapy in the public healthcare system and will not receive any guidance or exercise, as recommended in pragmatic studies. They will be monitored weekly by telephone call to check the onset of outpatient physical therapy, and adverse events. Like the TG, the period each CG participant will spend in the trial will depend on the time awaiting outpatient physical therapy. Participants in both the TG and CG will not be prohibited from receiving others interventions such as exercises on their own, physical activity (eg. walking), medications, or physical therapy elsewhere while on the waiting list, but this information will be recorded.
Data collection
Figure 2 shows the schedule of enrollment, interventions, and assessments (according to the SPIRIT). Outcomes will be assessed by in-person meetings at baseline (t0), at the end of the telerehabillitation protocol (t1), and after discharge from outpatient physical therapy or within six months of outpatient treatment (t2). All evaluations will be performed by a trained evaluator blinded to group allocation. All instruments show adequate validity and reliability for the older adults.48,49,50,51,52
In the baseline (t0), besides the outcomes, socio-demographic and clinical data will be collected, as well as data on the companion, and information on the use of communication technologies.
In the second evaluation (t1), satisfaction with the intervention and the TG app will also be evaluated. To minimize sample loss, the second evaluation will occur before the start of outpatient physical therapy or up to one week after the start of physical therapy treatment. The start of the outpatient physical therapy will be accompanied by weekly phone calls to both groups.
The final evaluation (t2) will take place on the last day of outpatient physical therapy or up to one week after discharge. The evaluation will consist of the collection of outcomes and information about outpatient physical therapy. Reasons for program discontinuity and follow-up losses will be recorded throughout the study.
Outcomes
Primary outcome
The primary outcome will be physical function measured by the Timed Up and Go (TUG) and the 30-second Chair Stand Test (30CST). These tests were chosen because they are simple, fast, widely used, and do not require special equipment.
The TUG was developed to measure the functional mobility of older people.53 The participant gets up from a chair and walks three meters alone or with the aid of a walking device, at a comfortable and safe speed, and then return and sit down again in the same chair.53
The 30CST consists of sitting and standing, tasks often performed daily.54,55 This test was developed as a measure of lower limb strength for older adults.49 The participant sits in a chair with arms crossed in front of the torso and must repeatedly stand and sit for 30 seconds as fast as possible.56
Secondary outcomes
The Physical Functioning Scale of the Brazilian version of the Medical Outcomes Short-Form Health Survey (SF-36) will be used to measure physical health.57 The Physical Functioning Scale presents ten questions; each one is scored from 1 to 3 according to the perceived limitation.58 The final score of the scale is calculated according to the orientation of the SF-36 authors ranges from 0-100, with lower scores indicating higher limitations.58
Pain will be measured by the visual analog scale with numerical (0-10) and color gradations.59
Health-related quality of life will be measured by the Brazilian version of EuroQol-5D (EQ-5D-3L). This instrument evaluates the patient's current health status in five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). EQ-5D-3L also includes a visual analog scale to record overall health status.60 The results of this instrument are widely used in economic evaluations.61
Performance perception and satisfaction will be measured by the Canadian Occupational Performance Measure (COPM).62 In this study, only the self-care area will be used. The participant lists the self-care activities they have difficulty performing, chooses the one they consider the most important, and ranks their performance and performance satisfaction from 0 to 10. Higher scores indicate better performance and performance satisfaction.
Economic evaluation
The economic evaluation will be carried out from the perspective of society and the Brazilian public healthcare system during the study period. The costs will be reported based on values updated to the year of data collection. In this phase, all information will follow the recommendations of the Brazilian Ministry of Health's Methodological Guidelines for Economic Evaluation.63 Cost measures will be obtained by estimates of health service utilization (public and private) due to the health condition that caused the referral to outpatient physical therapy and/or generated adverse events. The app development costs will be excluded.
Costs to the public healthcare system will be measured based on the use of health services and procedures reported by participants by weekly Google form platform and these data will only be assessed by researchers blinded to group allocation. Costs for hospital care, elective consultations, outpatient or home physical therapy, and medication will be included. These costs will be valued using standardized cost tables of the Brazilian public healthcare system.
Costs to society will include direct costs to participants and caregivers and loss of productivity. The calculation of direct expenses, such as medication, purchase of equipment, transportation, hiring caregivers, and health services will be based on surveys answered by participants. The cost of transportation will be evaluated by the distance between the participant's home and the physical therapy site, adjusted by the type of transportation used and the price of gasoline. Information on loss of productivity will be obtained for participants and non-contracted caregivers (e.g. family members) through surveys administered to participants who will indicate whether they have paid work, income from this work, and lost workdays due to the health condition.
The cost-consequence approach will be used to compare the results obtained by the participants in the primary and secondary outcomes with the costs for the two perspectives of analysis (society and public healthcare system). In the cost-utility analysis, the costs for the public healthcare system will be compared with the quality-adjusted life years (QALY) gained from the intervention, obtained by applying the EQ-5D-3L. Sensitivity analyses will be conducted to explore any degree of uncertainty in the estimates, such as sampling, time horizon, discount rate, and imputation of missing data.
Other outcomes
Adherence will be monitored through the records computed by the app and confirmed during the weekly calls to the TG. Participants who perform all the proposed exercises at least three times a week will be considered as adherents.
Adverse events will be monitored weekly during phone calls and will be reported in the study results. Adverse events are those harmful or unfavorable results that occur during or after exercise,64 such as nausea, headache, falling, and incapacitating pain. Events not related to the intervention will also be monitored. Participants who report a serious adverse event will be instructed to seek emergency medical services. The intervention will be interrupted if the adverse event makes it impossible for the participant to perform physical exercises.
Sample size
The sample size was based on the TUG primary outcome. An effect size of d=0.4, previously obtained by Brovold et al. (2012),65 power of 80%, alpha of 0.05, and abandonment rate of 15% were considered to estimate sample size using the G*Power 3.1 software. This resulted in a minimum sample size of 230 participants, 115 per group.
Data analysis plan
The outcome variables and the participants’ characteristics will be analyzed with descriptive statistics. The Kolmogorov-Smirnov test will be used to test the normality of the data. Comparison of TG and CG baselines will be conducted with parametric or non-parametric test.
Outcome group comparisons will be analyzed with the nonlinear mixed effect model,66 given that deconditioning follows a nonlinear path over time and the period individuals remain in the study is not homogeneous. Since the intervention time will be different among the participants, time will be treated as a random factor.
All data will be analyzed for intention-to-treat; that is, all random participants will be included in the analysis regardless of adherence to the protocol. The data will be analyzed by the R software (R Foundation for Statistical Computing, Vienna, Austria) with a significance level of 5%.