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

NCT06380127 | Completed

• 1 other identifier: CEFADE012021
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Keywords

Frail; Exercise; Concurrent training; Long-term care; Myokines

Outcome Measures

Primary Outcomes (1)

• Change from Baseline on Short Physical Performance Battery (SPBB)

  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).

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

Secondary Outcomes (4)

• Change from Baseline on Handgrip test

  Assessment at baseline and immediately after 12 weeks of intervention, in each period

• Change from baseline on isokinetic knee strength

  Change from baseline and 12 weeks in each intervention, in both periods

• Change from Baseline on circulating levels of myostatin

  Change from baseline and 12 weeks in each intervention, in both periods

• Change from Baseline on circulating levels of Decorin

  Assessment at baseline and immediately after 12 weeks of intervention, in each period

Study Arms (2)

Exercise

EXPERIMENTAL

Progressive concurrent exercise training

Behavioral: Exercise training

Usual Care

NO INTERVENTION

The usual care

Interventions

Exercise training BEHAVIORAL

The exercise intervention will take place at the nursing homes and consists of 12 weeks of supervised concurrent exercise training, performed thrice weekly on nonconsecutive days to avoid overtraining and fatigue. Each session will last 50-60 min and consist of a warm-up, resistance plus aerobic training, and a 5-min cool-down period. The resistance training will comprise 2-3 sets of 10 to 15 repetitions with a load equivalent to 40 to 70% of the 1-repetition maximum (1RM) for upper (i.e., bicep curl) and lower body exercises (i.e., seated knee extension). The sit-to-stand exercise will be performed as fast as possible according to each participant's capacity without external load. The recovery between sets is between 1 and 2 min. Afterwards, participants will perform walking exercises with changes in pace and direction. The duration of the aerobic training will progress from 5-10 min duration in the first weeks to 10-15 min. The sessions will end with stretching exercises.The exercise

Exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Faculty of Sports, University of Porto

Porto, 4000, Portugal

Location

Related Publications (1)

• Barros D, Silva-Fernandes A, Martins S, Guerreiro S, Magalhaes J, Carvalho J, Marques EA. Feasibility and Effectiveness of a 12-Week Concurrent Exercise Training on Physical Performance, Muscular Strength, and Myokines in Frail Individuals Living in Nursing Homes: A Cluster Randomized Crossover Trial. J Am Med Dir Assoc. 2024 Nov;25(11):105271. doi: 10.1016/j.jamda.2024.105271. Epub 2024 Sep 19.

  PMID: 39305935 RESULT

MeSH Terms

Conditions

Frailty; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joana Carvalho, PhD

  CIAFEL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The trial will follow a 28-week crossover design: 12 weeks for the first intervention period, a 4-week washout, and another 12 weeks for the second intervention period. Nursing homes (clusters) were randomized into sequences (AB or BA), where intervention A involve concurrent exercise training, and B is usual care. Data collection will occurre at four points: baseline, post-first intervention period, post-washout/pre-second intervention period and post-crossover.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: October 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: December 15, 2023
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)