Multicomponent Exercise Program on the Intrinsic Capacity (ICOPE) of Community-dwelling Older Adults in Primary Care

European University Spain

Status: Not yet enrolling

Conditions: Healthy Ageing

Treatments: Other: Vivifrail multicomponent exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT05744492

22/574

Details and patient eligibility

About

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.

Enrollment: 177 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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177 participants in 3 patient groups

Supervised Vivifrail (S-ViF)

Experimental group

Description:

A 12-week intervention program that consists of walking every day (the time is individually adjusted) and exercising 3 times a week. Shared features of the different programs are the inclusion of resistance, cardiovascular, balance and flexibility components. All exercises will be individually tailored. Once-per-week, subjects assigned to this group will attend the primary care center to execute one of the three exercise sessions per week under the supervision of the physical therapist.

Treatment:

Other: Vivifrail multicomponent exercise program

Non-supervised Vivifrail Group (NS-ViF)

Experimental group

Description:

A 12-week intervention program that consists of walking every day (the time is individually adjusted) and exercising 3 times a week. Shared features of the different programs are the inclusion of resistance, cardiovascular, balance and flexibility components. All exercises will be individually tailored. Subjects assigned to this group will follow a domiciliary-based program and they will not attend the primary care center to execute the exercises.

Treatment:

Other: Vivifrail multicomponent exercise program

Control group (UCG)

No Intervention group

Description:

Subjects will receive usual care following prevention protocols of Primary Care Services in Madrid. Concisely, the benefits of physical activity are individually explained and subjects are advised to walk as much as possible with the aim of reaching at least 30 minutes a day, 5 days a week, following the recommendations of the World Health Organization. No structured exercise-based interventions are programmed in this group.