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Completed

NCT Number: NCT06380127

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

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.

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Key information

Conditions

Frailty Behavior Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sports, University of Porto

Porto, 4000, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  1. 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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2024
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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