FrailtyNCT06380127

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

A study testing Exercise training in people with Frailty, run by Universidade do Porto at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Frailty
What is being tested?: Exercise training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 sitePortugal
Study dates: 1 Oct 2021to 15 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

Faculty of Sports, University of Porto
Porto, 4000

Other trials in Portugal

About this study

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

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.

Read the 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.

Conditions: Frailty
Being tested: Exercise training
Keywords: Frail, Exercise, Concurrent training, Long-term care, Myokines
Medical subject headings: Frailty, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exercise trainingBehavioural
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

Study groups in NCT06380127
Study group	Role	What they receive
Exercise	Experimental	Progressive concurrent exercise training Receives: Behavioral: Exercise training
Usual Care	No intervention	The usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202115 Dec 2023

First posted23 Apr 2024
Study start1 Oct 2021
Primary completion30 Sep 2023
Study completion15 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for FrailtyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06380127
Sponsor's protocol ID: CEFADE012021
Status last verified: Feb 2025
First submitted: 18 Apr 2024
Last updated: 21 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 39305935

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06380127
Acronym / sponsor ID: CEFADE012021
Conditions: Frailty
Keywords: Frail, Exercise, Concurrent training, Long-term care, Myokines
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Universidade do PortoUniversity, hospital or other
Study start: 1 Oct 2021 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 23 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Exercise	Experimental	Behavioral: Exercise trainingProgressive concurrent exercise training
Usual Care	No intervention	–The usual care

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exercise trainingThe 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	Behavioural	Exercise

Primary outcome

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).

4 secondary outcomes

Change from Baseline on Handgrip test
Time frame: 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
Change from Baseline on circulating levels of myostatin
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
Results publication: PubMed 39305935Barros 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joana Carvalho, PhD principal investigator

CIAFEL

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training in people with Frailty, run by Universidade do Porto at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline on Short Physical Performance Battery (SPBB) (time frame: Assessment at baseline and immediately after 12 weeks of intervention, in each period.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06380127, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.