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

February 19, 2025 updated by: Maria Joana Carvalho, Universidade do Porto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal, 4000
        • Faculty of Sports, University of Porto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
Progressive concurrent exercise training
Behavioral: Exercise training
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
No Intervention: Usual Care
The usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Assessment at baseline and immediately after 12 weeks of intervention, in each period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline on Handgrip test
Time Frame: 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
Assessment at baseline and immediately after 12 weeks of intervention, in each period
Change from baseline on isokinetic knee strength
Time Frame: 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 and 12 weeks in each intervention, in both periods
Change from Baseline on circulating levels of myostatin
Time Frame: Change from baseline and 12 weeks in each intervention, in both periods
Determination of myostatin levels in serum.
Change from baseline and 12 weeks in each intervention, in both periods
Change from Baseline on circulating levels of Decorin
Time Frame: Assessment at baseline and immediately after 12 weeks of intervention, in each period
Determination of decorin levels in serum.
Assessment at baseline and immediately after 12 weeks of intervention, in each period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Investigators

  • Principal Investigator: Joana Carvalho, PhD, CIAFEL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEFADE012021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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