The goal of this randomized controlled trial (RCT) is to analyze whether the effectiveness of a synchronous telerehabilitation program is better than a face-to-face physical therapy program in improving the physical fitness, functional status, and quality of life in frail male and female volunteers aged 60 years or older living in the community and haven frailty according to the modified Fried phenotype scale. The main research questions are: 1) Is a synchronous telerehabilitation program effective in improving the physical fitness, functional status and quality of life of frail older people?; 2) Is a synchronous telerehabilitation program more effective in improving the physical fitness, functional status and quality of life, compared to face-to-face physical therapy program, in frail older adults? In synchronous telerehabilitation program group, a healthcare professional will supervise up to four or five participants remotely exercising at home during each session, using a real-time videoconferencing app. Participants will be able to see and talk to both the health professional and the other participants. The exercise program will consist of 1-hour sessions carried out twice a week for 12 weeks. In the face-to-face physical therapy group, the exercise sessions will take place in a older person care center, which will also last 1 hour twice a week for 12 weeks. Regardless of the group, exercise sessions will include a mixture of cardiovascular, balance, strength, flexibility, and gait exercises.
None
None
Parallel
TeleActivate
BehavioralEach session will consist of a warm-up activity (5-10 min), main exercise activity (30-40 min), and cool-down activity (5-10 min) following the guidelines of multicomponent exercise program Vivifrail. Exercise intensity will be controlled based on the Rating of Perceived Exertion (RPE) on the Borg scale and heart rate measured with a smartwatch before, during, and after each exercise session according to the guidelines of the American College of Sports Medicine (ACSM), as explained below. The warm-up and cool-down activities will include stretching and walking in place (9≤RPE≤10 and 40\<55% maximum Heart rate (HRmax). While the main exercise activity will consist of strength, resistance exercise, cardiovascular exercises, and balance exercises (to avoid falls) performed using dumbbells, colour-coded resistance bands (Thera-Band; Hygenic Corp.) and a chair (11\<RPE≤15 and 55\<70 HRmax).
Lower limb strength
Will be measured using a five-repetition sit-to-stand test. The OAs will be asked to stand up and sit down, as quickly as possible, five times, from a chair without armrests located on a wall. The time will be measured from the beginning of the movement until the OA manages to stand up for the fifth time. The older adult's arms should be crossed over the chest during the test. The time will be recorded in seconds, and tenths of a second.
Cardiorespiratory fitness
Will be measured by a 2-minutes step test: The evaluator will count the number of full steps completed by the participant in 2 minutes. A full step is defined as a step performed while raising the knee up to a height corresponding to the midpoint between the patella and the iliac crest.
Upper limb strength
Will be estimated by the grip Strength Test using a previously calibrated BASELINE® brand hydraulic dynamometer. This evaluation will be carried out with the older people seated on a chair with a backrest, shoulders adducted, elbow flexed at 90º, forearm and wrist in a neutral position. The evaluated arm should not rest on any surface and the dynamometer used in a vertical position. older people will be asked to perform a maximum grip force with their dominant hand for 3 seconds, resting for 1 minute between each repetition, making two attempts. The highest grip value of the repetitions will be used. This protocol is described in Chilean national health survey 2016-2017.
Dynamic balance
Will be measured with the timed up and go test. The older people will be seated on a chair without armrests, with the back against the backrest and feet touching the ground. The older people will be asked to stand up and walk as usual, to a cone located 3 meters away, turn around and return to sit down. This test controls the time it takes to complete the circuit, starting from the moment the older people lifts his/her back from the chair, and ending when returning to the start position. The scale is, normal ≤10 seconds; slight risk of falling 11-20 seconds and, high risk \>20 seconds
Static balance
Will be measured using the unipodal stance test. The participant will be asked to cross their arms over their chest, rest their hands on their shoulders, and triple-flex one leg at 90°, staying as long as possible on one foot (maximum of 30 seconds). The test will be repeated three times, the best time obtained will be considered for the study. According to national studies, it is assumed that an older people has a high risk of falling due to not being able to maintain this position for ≥5 seconds
Quality of life
To assess the quality of life, we will use the Short Form-36 Health Survey, Spanish version. The Short Form-36 Health Survey is a self-report instrument that contains 36 questions from 8 dimensions related to people's health: physical function, physical role, bodily pain, vitality, social function, emotional role, mental health, and general health. The score obtained corresponds to values on a scale of 0 to 100. A higher score reflects a better quality of life.
Sociodemographic background
The sociodemographic background of the older adults will be recorded as age, gender (male/female) and geographical origin (rural or urban), educational level (basic \<8 years, middle 8-12 years, or higher education \>12 years), presence of comorbidities (diabetes mellitus, arterial hypertension, dyslipidemia). Nutritional status will be classified based on the body mass index (BMI). Weight (kg) and height (m) will be combined to report BMI in kg/m\^2. Cut-off points will be considered (low weight: \<22.9 kg/m2; normal weight: 23.0-27.9 kg/m2; overweight: 28.0-31.9 kg/m2; and obesity: ≥32.0 kg/m2). The questions and the classification indicated in the National Health Survey 2016-2017, will be used.
Click on the lead sponsor to view all of their trials.
Marina Alvarado
Lead sponsor
Universidad Catolica Silva Henriquez
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
