Feasibility and Effectiveness of Concurrent Exercise Training on Frail Older Adults Living in Nursing Homes

Not Applicable

Completed

• Conditions: Frailty
• Interventions: Behavioral: Exercise training

• Registration Number: NCT06380127
• Lead Sponsor: Universidade do Porto

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.

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-15
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise training	Progressive concurrent exercise training

Primary Outcome Measures

Name	Time	Method
Change from Baseline on Short Physical Performance Battery (SPBB)	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 Outcome Measures

Name	Time	Method
Change from Baseline on circulating levels of myostatin	Change from baseline and 12 weeks in each intervention, in both periods	Determination of myostatin levels in serum.
Change from baseline on isokinetic knee strength	Change from baseline and 12 weeks in each intervention, in both periods	The dynamic concentric muscle strength of the knee flexors and extensors will be measured on an isokinetic dynamometer (Biodex System 4 Pro; Biodex, Shirley, NY).The measurements will follow the manufacturer's instructions for knee extension/flexion at the angular velocity of 60/s (1.05 rad/s). After a few repetitions for familiarization, each participant will perform three maximal repetitions at 60/s with their preferred leg.
Change from Baseline on Handgrip test	Assessment at baseline and immediately after 12 weeks of intervention, in each period	Handgrip strength will be obtained with a Jamar Plus + Digital hand dynamometer (Sammons Preston Inc., Bolingbrook, Illinois, USA).Measurements will be carried out following the American Society of Hand Therapists recommendations, and each participant will perform three attempts with a pause of 15s between trials
Change from Baseline on circulating levels of Decorin	Assessment at baseline and immediately after 12 weeks of intervention, in each period	Determination of decorin levels in serum.

Trial Locations

Locations (1)

Faculty of Sports, University of Porto; 🇵🇹 Porto, Portugal