Effects of a Multicomponent Exercise Program on the Intrinsic Capacity of Community-dwelling Older Adults Under the ICOPE Framework: Study Protocol for a Multi-center Randomized Control Trial in Primary Care
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Healthy Ageing
- Sponsor
- European University Spain
- Enrollment
- 177
- Primary Endpoint
- Change from baseline to 12-weeks in the Short Physical Performance Battery (SPPB) score
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Maria-Jose Gimenez Mestre
Principal Investigator, Physical Therapy & Health Sciences Research Group, Adjunct lecturer
European University Spain
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change from baseline to 12-weeks in the Short Physical Performance Battery (SPPB) score
Time Frame: 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 12-weeks to 24-weeks in the Short Physical Performance Battery (SPPB) score
Time Frame: 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)
Change from baseline to 6-weeks in the Short Physical Performance Battery (SPPB) score
Time Frame: 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)
Secondary Outcomes
- Change in visual capacity from baseline (T0) to 6-weeks (T1)(From baseline (T0) to 6-weeks (T1))
- Change in the isometric handgrip strength from baseline (T0) to 12-weeks (T2)(From baseline (T0) to 12-weeks (T2))
- Change from baseline to 12-weeks in the Montreal Cognitive Assessment (MoCA) score(From baseline (T0) to 12-weeks (T2))
- Change in visual capacity from 12-weeks (T2) to 24-weeks (T3)(From 12-weeks (T2) to 24-weeks (T3))
- Change in the isometric handgrip strength from 12-weeks (T2) to 24-weeks (T3)(From 12-weeks (T2) to 24-weeks (T3))
- Change from baseline to 6-weeks in the Montreal Cognitive Assessment (MoCA) score(From baseline (T0) to 6-weeks (T1))
- Change from baseline to 12-weeks in the Geriatric Depression Scale (GDS-15)(From baseline (T0) to 12-weeks (T2))
- Change from baseline to 6-weeks in the Geriatric Depression Scale (GDS-15)(From baseline (T0) to 6-weeks (T1))
- 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))
- Change from 12-weeks to 24-weeks in the Geriatric Depression Scale (GDS-15)(From 12 weeks (T2) to 24-weeks (T3))
- Change from baseline (T0) to 6-weeks (T1) in the Mini-Nutritional Assessment -Short Form (MNA-SF)(From baseline (T0) to 6-weeks (T1))
- Change from 12 to 24-weeks in the Montreal Cognitive Assessment (MoCA) score(From 12-weeks (T2) to 24-weeks (T3))
- Change from baseline (T0) to 12-weeks (T2) in the Mini-Nutritional Assessment -Short Form (MNA-SF)(From baseline (T0) to 12-weeks (T2))
- Change in visual capacity from baseline (T0) to 12-weeks (T2)(From baseline (T0) to 12-weeks (T2))
- Change in the isometric handgrip strength from baseline (T0) to 6-weeks (T1)(From baseline (T0) to 6-weeks (T1))
- Change in hearing capacity from baseline (T0) to 6-weeks (T1)(From baseline (T0) to 6-weeks (T1))
- Change in hearing capacity from 12-weeks (T2) to 24-weeks (T3)(From 12-weeks (T2) to 24-weeks (T3))
- Change in hearing capacity from baseline (T0) to 12-weeks (T2)(From baseline (T0) to 12-weeks (T2))