NCT05744492

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: European University Spain · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Ageing

Interventions

Type	Name	Description
OTHER	Vivifrail multicomponent exercise program	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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2023-02-27
• Last updated: 2023-02-28