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Clinical Trials/NCT06380127
NCT06380127
Completed
Not Applicable

Feasibility and Effectiveness of a 12-week Concurrent Exercise Training on Physical Performance, Muscular Strength and Circulating Myokines in Frail Older Adults Living in Nursing Homes: a Cluster Randomized Crossover Trial

Universidade do Porto1 site in 1 country46 target enrollmentOctober 1, 2021
ConditionsFrailty

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
Universidade do Porto
Enrollment
46
Locations
1
Primary Endpoint
Change from Baseline on Short Physical Performance Battery (SPBB)
Status
Completed
Last Updated
last year

Overview

Brief Summary

The present study is a crossover randomized controlled trial that aims to investigate the effects of concurrent exercise training over usual care on physical performance, muscle strength, and myokines concentrations in frail older adults living in nursing homes.The main questions it aims to answer is: Can a 12-week exercise intervention provide beneficial effects on physical performance, muscle strength and myokines among the most frail participants? Researchers will compare this intervention to usual care. Nursing homes (comprising participants) will be randomly assigned to a sequence of interventions (AB or BA), being A -exercise and B usual care. Participants will be assessed before and after each intervention.

Detailed Description

The present study is a crossover randomized controlled trial that aims to investigate the effectiveness of a concurrent exercise training over usual care on physical performance, muscle strength, and myokines concentrations in frail older adults living in nursing homes. Nursing homes will be randomly assigned to receive a sequence of interventions (AB or BA), being A -exercise and B usual care. Participants will receive a 12-weeks of either exercise intervention or usual care. A 4-week washout period will be conducted between interventions. Participants will assessed before and after each intervention.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
December 15, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria Joana Carvalho

Principal Investigator

Universidade do Porto

Eligibility Criteria

Inclusion Criteria

  • Classified as frail according to the Fried criteria (e.g., frailty phenotype ≥ 3 criteria);
  • Not having participated in any exercise intervention for the last 3 months;
  • Being able to ambulate (with/without assistance).

Exclusion Criteria

  • Any contraindication that could affect physical exercise performance or testing procedures, including terminal illness, uncontrolled disease or other unstable medical condition;
  • Bone fracture in the past three months;
  • having a short physical performance battery score (SPPB) \< 3.

Outcomes

Primary Outcomes

Change from Baseline on Short Physical Performance Battery (SPBB)

Time Frame: Assessment at baseline and immediately after 12 weeks of intervention, in each period.

The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).

Secondary Outcomes

  • Change from Baseline on circulating levels of myostatin(Change from baseline and 12 weeks in each intervention, in both periods)
  • Change from baseline on isokinetic knee strength(Change from baseline and 12 weeks in each intervention, in both periods)
  • Change from Baseline on Handgrip test(Assessment at baseline and immediately after 12 weeks of intervention, in each period)
  • Change from Baseline on circulating levels of Decorin(Assessment at baseline and immediately after 12 weeks of intervention, in each period)

Study Sites (1)

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