Healthy Ageing
Conditions
Keywords
Frail Older Adults, Elderly, Primary care, Physical Therapy
Brief summary
A three-branch multi-center randomized clinical trial to be conducted in 6 public Primary Care centers located in the city of Madrid (Spain). A total of 180 older adults (\>=70 years old) presenting with declines in the intrinsic capacity (IC) locomotion domain will be recruited in the participating centers. They will be randomized in a 1:1:1 ratio to a center-based supervised Vivifrail multicomponent exercise (MCE) program, a home-based non-supervised Vivifrail MCE program, or to a control group. The intervention consists of thrice-a-week exercise sessions encompassing strength, aerobic, flexibility, and balance and gait training tailored to the individual's baseline functional ability. IC will be assessed through its operational domains following ICOPE guidelines at baseline and 6 and 12 weeks after the start of the intervention. Secondarily, effects on frailty status and health-related quality of life will be evaluated. This study might bring new evidence around the ICOPE recommendation on the Vivifrail MCE for the management of IC locomotion declines in Primary Care for the first time. Gaining insight on exercise interventions for IC promotion/maintenance will reinforce current recommendations and contribute to the development of real-world strategies for healthy aging promotion.
Interventions
Resistance: 3 sets of 2 repetitions of 3-4 exercises with a 1 to 3-minute break between sets. Intensity from 30-repetition maximum (RM) at weeks 1-6 to 20-RM at weeks 7-12. Balance training: both static and dynamic. Subjects will increase the number of repetitions, the difficulty of the exercises or will add external perturbations to the tasks (unstable surfaces, obstacles, or visual deprivation) along the duration of the interventions to guaranteeing progression. In the case of high risk of falling the number, frequency and volume of balance exercises will be increased. Flexibility: a set of stretching exercises at the end of each session. Subjects will be instructed to stretch until they feel tension in their muscles without reaching discomfort. Stretching will be maintained for 10 sec. and repeated 2-3 times. Cardiovascular: walking-based activities oriented to increase cardiorespiratory fitness. They will range from 5-10 sec. to 45 min/session.
Sponsors
Public Health Service of Madrid
European University Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Physical therapists in charge of the intervention will not be endpoint's evaluators. Participants will be informed and encouraged not to disclose their assignment to the endpoints' evaluators, which will remain blinded to individual's membership. Investigators responsible for the statistical analysis will be blinded.
Intervention model description
Three-branch multi-center randomized clinical trial with 1:1:1 allocation to a center-based supervised Vivifrail MCE, a home-based non-supervised Vivifrail MCE program, or to a control group.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥70 years old * Attending participating primary care centers * Pre-frailty or frailty according to Fried's criteria * SPPB \<10 * Barthel Index Score ≥60 * Being able to communicate and ambulate with or without technical aids * Relative/caregiver willingness to supervise the exercise (if needed)
Exclusion criteria
* Major cognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorders V criteria or the Global Deterioration Scale by Reisberg (GDS\>4) * Physically active individuals (moderate-to-vigorous physical activity greater than 150 minutes per week according current physical activity guidelines for older adults) or those already participating in structured physical exercise programs * Diagnosis of a terminal illness/life expectancy ≤3months * Lack of possibility of follow-up * Institutionalized or awaiting institutionalization * Any contraindications for physical exercise or testing procedures, including but not limited to: myocardial infarction in the past 6 months; unstable angina pectoris; uncontrolled arrhythmia; unstable cardiovascular disease or other unstable medical condition; uncontrolled arterial hypertension; recent pulmonary thromboembolism; upper or lower extremity fracture in the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to 12-weeks in the Short Physical Performance Battery (SPPB) score | From baseline (T0) to 12-weeks (T2) | Short Physical Performance Battery score measuring balance, lower extremity strength, and functional capacity in older adults. Minimum 0, maximum 12 (best) |
| Change from baseline to 6-weeks in the Short Physical Performance Battery (SPPB) score | From baseline (T0) to 6-weeks (T1) | Short Physical Performance Battery score measuring balance, lower extremity strength, and functional capacity in older adults. Minimum 0, maximum 12 (best) |
| Change from 12-weeks to 24-weeks in the Short Physical Performance Battery (SPPB) score | From 12-weeks (T2) to 24-weeks (T3) | Short Physical Performance Battery score measuring balance, lower extremity strength, and functional capacity in older adults. Minimum 0, maximum 12 (best) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to 6-weeks in the Montreal Cognitive Assessment (MoCA) score | From baseline (T0) to 6-weeks (T1) | Cognitive function (memory, language, attention, executive function, visuospatial and orientation). Minimum 0, maximum 30 (best) |
| Change from 12 to 24-weeks in the Montreal Cognitive Assessment (MoCA) score | From 12-weeks (T2) to 24-weeks (T3) | Cognitive function (memory, language, attention, executive function, visuospatial and orientation). Minimum 0, maximum 30 (best) |
| Change from baseline to 12-weeks in the Geriatric Depression Scale (GDS-15) | From baseline (T0) to 12-weeks (T2) | Depressive symptoms measured with the Geriatric Depression Scale (GDS-15), minimum 0, maximum 15 (worse) |
| Change from baseline to 6-weeks in the Geriatric Depression Scale (GDS-15) | From baseline (T0) to 6-weeks (T1) | Depressive symptoms measured with the Geriatric Depression Scale (GDS-15), minimum 0, maximum 15 (worse) |
| Change from 12-weeks to 24-weeks in the Geriatric Depression Scale (GDS-15) | From 12 weeks (T2) to 24-weeks (T3) | Depressive symptoms measured with the Geriatric Depression Scale (GDS-15), minimum 0, maximum 15 (worse) |
| Change from 12-weeks (T2) to 24-weeks (T3) in the Mini-Nutritional Assessment -Short Form (MNA-SF) | From 12-weeks (T2) to 24-weeks (T3) | Risk of malnutrition measured with the Mini-Nutritional Assessment -Short Form (MNA-SF), minimum 0, maximum 14 (best) |
| Change in the isometric handgrip strength from baseline (T0) to 12-weeks (T2) | From baseline (T0) to 12-weeks (T2) | Best attempt of the isometric handgrip strength (kg) of the dominant hand evaluated by a hand-held dynamometer |
| Change from baseline (T0) to 6-weeks (T1) in the Mini-Nutritional Assessment -Short Form (MNA-SF) | From baseline (T0) to 6-weeks (T1) | Risk of malnutrition measured with the Mini-Nutritional Assessment -Short Form (MNA-SF), minimum 0, maximum 14 (best) |
| Change in the isometric handgrip strength from 12-weeks (T2) to 24-weeks (T3) | From 12-weeks (T2) to 24-weeks (T3) | Best attempt of the isometric handgrip strength (kg) of the dominant hand evaluated by a hand-held dynamometer |
| Change in visual capacity from baseline (T0) to 12-weeks (T2) | From baseline (T0) to 12-weeks (T2) | Distance and near vision assessed with WHO simple eye charts |
| Change in visual capacity from baseline (T0) to 6-weeks (T1) | From baseline (T0) to 6-weeks (T1) | Distance and near vision assessed with WHO simple eye charts |
| Change in visual capacity from 12-weeks (T2) to 24-weeks (T3) | From 12-weeks (T2) to 24-weeks (T3) | Distance and near vision assessed with WHO simple eye charts |
| Change in hearing capacity from baseline (T0) to 12-weeks (T2) | From baseline (T0) to 12-weeks (T2) | HearWHO App consisting of an automated digit-in-noise test |
| Change in hearing capacity from baseline (T0) to 6-weeks (T1) | From baseline (T0) to 6-weeks (T1) | HearWHO App consisting of an automated digit-in-noise test |
| Change in hearing capacity from 12-weeks (T2) to 24-weeks (T3) | From 12-weeks (T2) to 24-weeks (T3) | HearWHO App consisting of an automated digit-in-noise test |
| Change in the isometric handgrip strength from baseline (T0) to 6-weeks (T1) | From baseline (T0) to 6-weeks (T1) | Best attempt of the isometric handgrip strength (kg) of the dominant hand evaluated by a hand-held dynamometer |
| Change from baseline (T0) to 12-weeks (T2) in the Mini-Nutritional Assessment -Short Form (MNA-SF) | From baseline (T0) to 12-weeks (T2) | Risk of malnutrition measured with the Mini-Nutritional Assessment -Short Form (MNA-SF), minimum 0, maximum 14 (best) |
| Change from baseline to 12-weeks in the Montreal Cognitive Assessment (MoCA) score | From baseline (T0) to 12-weeks (T2) | Cognitive function (memory, language, attention, executive function, visuospatial and orientation). Minimum 0, maximum 30 (best) |
Contacts
Primary ContactMaria-Jose Gimenez, PhD
Outcome results
None listed