Effect of an Exercise Program for Frail Older Adults

NCT05946109 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2024-12-27

No results posted yet for this study

Summary

Despite the high level of evidence for physical activity as a countermeasure for frailty, the current Flemish standard of care does not include structural PA interventions for community-dwelling frail older adults. One barrier for this, is the high cost of supervised physical activity programmes.

Therefore, in this pragmatic randomised controlled trial, the investigators will consider the Flemish current standard of care for frail older adults as a control group. Intervention condition 1 reflects the state-of-the-art physical activity intervention provided by professionals and intervention condition 2 consists of the same intervention provided by trained volunteers. It is hypothesized that the intervention in both intervention conditions will have significant effects on functional ability, cognition, loneliness, self-management, subjective health and meaningful activities and that it can alleviate the financial burden of condition 1 (cost-effectiveness). The pretrajectory of this study was based on the 'British Medical Research Council guidance' for the development and evaluation of complex interventions. This resulted in a comprehensive, state-of-the art personalised physical activity programme for community-dwelling frail older adults: ACTIVE-AGE@home. The programme adheres to current guidelines for physical activity and exercise for frail older adults and considers low threshold and meaningful activities for the participants. The latter perfectly aligns with the complex bio-psychosocial components of frailty. Positive results will help reduce negative outcomes of frailty in older adults and will also reduce health and social expenditures. This study aligns with a 'prevention and health promotion' model.

Conditions

Interventions

BEHAVIORAL

ACTIVE-AGE@home

functional, homebased training program offering basic functional exercises connected to meaningful activities, lifestyle coaching and motivational interviewing; derived from evidence-based training principles . Through a precise application of the FITT-VP\* guidelines, a progressive and balanced program was designed and piloted in different proof-of-concept studies. The uniqueness of the program lies in the multi-component approach which brings together functional exercises for (1) muscle strength/muscle endurance, (2) aerobic endurance, (3) flexibility, motor ability and balance and (4) meaningful daily activities, in a home-based environment. The frail participants are visited three times a week during 24 weeks with in total 72 sessions. Each session is 1 hour in duration. Thus they receive 72 training hours. \*(Frequency, Intensity, Time, Type of exercises, Volume and Progression)

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER
  • Universiteit Antwerpen

    collaborator OTHER
  • Odisee University college for applied sciences

    collaborator OTHER
  • Artevelde University of Applied Sciences

    collaborator UNKNOWN
  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Patricia De Vriendt, Prof dr · VUB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-04
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Belgium

Study Locations

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Entities

Diseases

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 NCT05946109 on ClinicalTrials.gov