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

NCT05744492 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2023-02-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Public Health Service of Madrid

    collaborator OTHER

  • European University Spain

    lead OTHER

Principal Investigators

  • Maria-Jose Gimenez, PhD · European University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2025-03-31
Completion
2025-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05744492 on ClinicalTrials.gov