Intervention group
Participants in the intervention group received an eight-week physical activity and education program in addition to usual practice in Primary Care. The physical activity and education program was adapted from a similar program developed by Tse et al. (2014) for older persons living in nursing homes that reduced pain intensity and improved emotional wellness of the participants reporting better results in happiness, loneliness, life satisfaction and depression [27].
The physical activity and education program was developed once a week for eight weeks in a conference and multi-function room in the Primary Care Centre. Each session lasted for 60 minutes, 15 minutes for warming-up and 45 minutes for exercises that changed in each session: shoulder and neck exercises; back exercises; knee and ankle exercises; hip exercises; balance exercises; falls prevention education; questions, answers and reflections; revision, reflections, evaluation and goodbye. Participants made suggested exercises accompanied by the instructor. After each session, they received a document with pictures that described the exercises of the day.
Measures
The main outcome variable in this study was perceived health-related quality of life. Data on pain intensity, frailty status, physical performance, depression, basic activities of daily living and satisfaction with the intervention were also recorded.
Quality of life
Participants’ perceived health related quality of life was assessed with the EuroQol 5D-5L (EQ-5D-5L) [28]. This questionnaire consists of five dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with five levels of problems. It also includes a Visual Analogue Scale with a range 0-100 in which higher scores indicates better quality of life. The results of the five dimensions are transformed in an index value by a calculator with different value sets depending on the setting country which has been validated in our context [29].
Pain intensity
It was assessed with the Visual Analogue Scale of the Short Form of McGill Pain Questionnaire [30] ranging from “no pain = 0mm” to “unwilling pain = 100mm”. Scores were measured to the nearest millimetre with a ruler. Minimally clinically important difference for VAS is 23 mm [31].
Frailty
Subjects were classified as frail, pre-frail or robust according to the five criteria of the Survey of Health, Ageing and Retirement in Europe Frailty Index (SHARE-FI) [32]:
Exhaustion: by the positive response to the question: ‘In the last month, have you had too little energy to do the things you wanted to do?’
Weight loss: by reporting a diminution in desire for food in response to the question: ‘What has your appetite been like?’
Weakness: assessed by handgrip strength using a dynamometer twice in each hand. The highest measurement is selected.
Slowness: by positive answer to one of the following questions: ‘Because of a health problem, do you have difficulty walking 100 meters or climbing one flight of stairs without resting?’
Low activity: assessed by the question: ‘How often do you engage in activities that require a low or moderate level of energy such as gardening, cleaning the car or doing a walk?’
The aim of the SHARE-FI is to summarize those variables in a single discreet factor (DFactor) with three classes: non-frail, pre-frail and frail. Changes in 0.5 DFactor score (DFS) were described as an improvement in frailty status [33]. The formula for the DFS is different in men and women:
Women: If predicted DFS < 0.31, NON-FRAIL; if predicted DFS < 2.13, PRE-FRAIL; if predicted DFS < 6, FRAIL
Men: If predicted DFS < 1.21, NON-FRAIL; if predicted DFS < 3.00, PRE-FRAIL; if predicted DFS < 7, FRAIL
Physical performance
The Short Physical Performance Battery (SPPB) was used [34]. It consists of three tests: balance skills, gait speed and chair stands. Balance is assessed using side-by-side, semi-tandem and tandem stands. Gait speed was tested with two four meters walk with or without assistive devices. The ability to stand from a chair and return to seated position five times with arms crossed was also tested. A final score was calculated ranging from zero (worst performance) to twelve (best performance).
Basic Activities of Daily Living
Basic Activities of Daily Living (bADL) dependence was assessed by Barthel ADL index [25]. It assesses the help needed with ten variables: feeding, bathing, grooming, dressing, urinary incontinence, faecal incontinence, toilet use, transfers bed to chair, mobility and climbing stairs.
Depression
Depression was assessed using the 5-items Geriatric Depression Scale [35]. It comprises five questions with yes or no answers. It is a commonly used tool in Primary Care and it has been validated in our context [36].
Further measurements
Satisfaction with the program was assessed using the 8-items Clients Satisfaction Questionnaire (CSQ-8) [37]. It is a generic questionnaire with 8 questions (4 of them with reverse score) about participants’ satisfaction with the intervention received, if they feel that the intervention was useful and if they would recommend it to their counterparts.
Sociodemographic characteristics like age, gender or if participants live alone or in family were also recorded.