Clinical trial NCT06380127: Feasibility and Effectiveness of Concurrent Exercise Training on Frail Older Adults Living in Nursing Homes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: Frail
Exercise
Concurrent training
Long-term care
Myokines
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 46
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline on Short Physical Performance Battery (SPBB)
timeFrame: Assessment at baseline and immediately after 12 weeks of intervention, in each period.
Secondary outcomes:
measure: Change from Baseline on Handgrip test
timeFrame: Assessment at baseline and immediately after 12 weeks of intervention, in each period
measure: Change from baseline on isokinetic knee strength
timeFrame: Change from baseline and 12 weeks in each intervention, in both periods
measure: Change from Baseline on circulating levels of myostatin
timeFrame: Change from baseline and 12 weeks in each intervention, in both periods
measure: Change from Baseline on circulating levels of Decorin
timeFrame: Assessment at baseline and immediately after 12 weeks of intervention, in each period
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Faculty of Sports, University of Porto
Study officials:
affiliation: CIAFEL
name: Joana Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.