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Frailty SyndromeTrackFrailtyNCT06812286

TrackFrailty Project

A study testing Less-volume and More-volume in people with Frailty Syndrome, run by University of Beira Interior at 6 sites in Portugal.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The TRACKFRAILTY project aims to answer the following main research questions: i) What is the prevalence of physical frailty in individuals living in residential care facilities (RCF) from Portugal's Cova da Beira subregion (Interior Center Region)? ii) What factors best predict frailty status? iii) Is strength… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Frailty Syndrome
What is being tested?
Less-volume and More-volume
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
6 sitesPortugal
Study dates
1 Jun 2025to Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women residing in residential care facilities (RFC) from the Cova da Beira subregion of Portugal
  • Non-frail, pre-frail, and frail individuals (prevalence study)
  • Pre-frail and frail individuals (randomized controlled trial)
  • Capable of collaborating with the research team members
  • Capable of giving written or oral informed consent

Who cannot join

  • Severe dementia (inability to speak or communicate with permanent care and assistance)
  • Hospitalized and bedridden individuals

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Portugal6 sites
  • Santa Casa da Misericórdia da Covilhã

    Covilha, Castelo Branco District, 6200-082

  • Centro Social Nossa Senhora da Conceição

    Covilha, Castelo Branco District, 6200-236

  • Lar de São José

    Covilha, Castelo Branco District, 6200-352

  • Associação Centro Social Sagrado Coração Maria

    Covilha, Castelo Branco District, 6200-571

  • Centro Social Vales do Rio

    Covilha, Cas, 6200-811

  • Santa Casa da Misericórdia do Fundão

    Fundão, Castelo Branco District, 6230-338

Other trials in Portugal

About this study

Official title: TrackFrailty: Track to Prevent, Mitigate, and Reverse Frailty

The TRACKFRAILTY project aims to answer the following main research questions:

  1. What is the prevalence of physical frailty in individuals living in residential care facilities (RCF) from Portugal's Cova da Beira subregion (Interior Center Region)? ii) What factors best predict frailty status? iii) Is strength training effective in reversing physical frailty in RCF residents? iv) In the long term, what dose of strength training volume is needed to promote the most significant health benefits in frail RCF residents? Based on these research questions, the TRACKFRAILTY project aims to quantify the prevalence of frailty in Portuguese RCF residents from the Cova da Beira subregion and analyze the effects of long-term strength training with different volumes on reversing physical frailty.
Read the detailed description

The TRACKFRAILTY project will consist of two primary research activities. Activity one will be a cross-sectional study to quantify the prevalence of physical frailty in residential care facility (RCF) residents from Portugal's Cova da Beira subregion (Interior Center Region). Activity two will be a randomized controlled trial to compare different strength training volumes for reversing frailty in RCF residents.

The prevalence study will include a representative sample of RCF residents from Portugal's Cova da Beira subregion. The investigators will use a comprehensive recruitment strategy, including contacts and meetings with the technical directors of several RCFs from the Cova da Beira subregion. Participants must comply with the inclusion criteria to make part of the study, namely men or women aged 50 and above residing in RCFs in Cova da Beira, capable of collaborating with the research team members, and giving written or oral informed consent. Exclusion criteria will comprise individuals with severe dementia (inability to speak or communicate with permanent care and assistance) and hospitalized and bedridden individuals.

After recruitment, the investigators will implement an evaluation protocol in two parts. The first part will include the collection of i) sociodemographic data, ii) diseases, iii) medications, iv) smoking status and alcohol consumption, v) self-perceived health-related quality of life, vi) self-reported unintentional weight loss, vii) falls history (last 12 months); viii) disability level, ix) self-reported exhaustion, x) physical activity level, xi) cognitive function, xii) emotional state, and xiii) relational/social aspects. The second part will include the collection of i) hemodynamic data, ii) anthropometric data, iii) lower extremity function data, and iv) upper extremity function data. The investigators will assess frailty using Fried's criteria (self-reported unintentional weight, self-reported exhaustion, low physical activity, muscle weakness, and slowness). Individuals with 3-5 criteria will be considered frail, 1-2 pre-frail, and 0 non-frail. Frail and pre-frail individuals will be invited to participate in the randomized controlled trial.

Research activity two will be a randomized, single-blind, three-arm (two experimental groups and one control group), parallel-group study of 30 weeks. The investigators will randomly assign the participants into three groups: less-volume (LV), more-volume (MV), and control (CG). The CG will perform stretching exercises supervised by two exercise physiologists during the intervention (two sessions per week). The LV and MV groups will undergo three 10-week strength training cycles, each with two weekly sessions. In the first cycle, LV will perform around 1500 total repetitions, while MV will perform around 2000. In the second and third cycles, the volume will increase by 20% with reference to the previous cycles in both experimental groups. Training frequency, exercises, and intensities will be the same in both groups. In brief, participants will perform 1-3 sets per exercise of 4-7 repetitions (LV) or 6-10 repetitions (MV) with intensities ranging from 5% to 10% of body weight and 1-10 kg. Strength exercises will include chair squats, seated medicine ball throws, seated knee extensions, seated shoulder presses, standing calf raises, standing biceps curls, seated lateral raises, and chair stand + 4-meter walk.

The investigators will administer the evaluation protocol described in research activity one before the first 10-week training cycle and after the first, second, and third 10-week training cycles. The primary outcome measure will be the frailty phenotype (Fried's criteria). The secondary outcome measures will include physical tests, cognitive function, emotional state, relational aspects, health-related quality of life, falls, feasibility, and safety. A statistician will analyze the data following an intention-to-treat and per-protocol analysis.

Being tested
Less-volume, More-volume, Control
Keywords
Muscle Strength, Functional Performance, Cognitive Impairment, Depression, Anxiety, Social Support, Quality of Life, Resistance Training, Exercise, Nursing Homes, Aging
Medical subject headings
Frailty, Cognitive Dysfunction, Depression, Anxiety Disorders, Motor Activity

What participants receive

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

  • Less-volumeOther

    In the first 10-week cycle, the less-volume group will perform around 1500 repetitions per intervention. Participants will perform 1-3 sets of 4-7 repetitions per exercise with intensities ranging from 5% to 10% of body weight and 1-10 kg. Strength exercises will include chair squats, seated medicine ball throws, seated knee extensions, seated shoulder presses, standing calf raises, standing biceps curls, seated lateral raises, and chair stand + 4-meter walk. In the second and third 10-week training cycles, volume will increase by 20% with respect to the previous cycles. Two exercise physiologists will supervise training sessions.

  • More-volumeOther

    In the first 10-week cycle, the more-volume group will perform around 2000 repetitions per intervention. Participants will perform 1-3 sets of 6-10 repetitions per exercise with intensities ranging from 5% to 10% of body weight and 1-10 kg. Strength exercises will include chair squats, seated medicine ball throws, seated knee extensions, seated shoulder presses, standing calf raises, standing biceps curls, seated lateral raises, and chair stand + 4-meter walk. In the second and third 10-week training cycles, volume will increase by 20% with respect to the previous cycles. Two exercise physiologists will supervise training sessions.

  • ControlOther

    Participants in the control group will undergo sham training twice weekly for 30 weeks, consisting of stretching exercises supervised by two exercise physiologists.

Study groups in NCT06812286
Study groupRoleWhat they receive
Less-volumeExperimentalThree 10-week strength training cycles.
Receives: Other: Less-volume
More-volumeExperimentalThree 10-week strength training cycles.
Receives: Other: More-volume
ControlOtherStretching exercises.
Receives: Other: Control

What is being measured

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

  1. Frailty phenotype

    Fried's criteria will be used to assess frailty (unintentional weight loss, exhaustion, low physical activity, slowness, and muscle weakness).

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

Secondary outcomes (15)
  1. Short Physical Performance Battery (SPPB)

    The SPPB consists of three tests (balance, 4-meter walking, and 5-repetition sit-to-stand), and the score ranges from 0-12, with lower scores indicating worse physical function.

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

  2. 10-meter walking test

    Participants will walk 10 m in a linear path, and time (s) will be measured.

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

  3. 6-minute walking test

    Participants will walk back and forth on 10 to 15 m paths for 6 minutes, and the total distance (m) covered during the stipulated time will be measured.

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

  4. Handgrip strength

    A handheld dynamometer will be used to measure handgrip strength (seated position).

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

  5. 1-kg medicine ball throw

    In a seated position, participants will throw the 1-kg medicine ball, and the distance (m) will be measured using a tape measure.

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

  6. Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) will be used to detect cognitive impairment. It assesses different cognitive domains, such as memory, executive functioning, attention, language, visuospatial, and orientation, and the maximum score is 30 (lower scores indicate different cognitive impairment levels).

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

  7. Satisfaction With Life Scale (SWLS)

    The Satisfaction with Life Scale (SWLS) consists of five items, each scored on a 7-point Likert scale ranging from "strongly disagree" to "strongly agree". The SWLS score is the sum of the item scores, ranging from 5 (lowest satisfaction) to 35 (highest satisfaction).

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

  8. Geriatric Depression Scale (GDS)

    The Geriatric Depression Scale (GDS) consists of 30 questions answered with "yes" or "no". The GDS score is the sum of all answers, with higher scores indicating higher depression levels.

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

  9. Geriatric Anxiety Inventory (GAI)

    The Geriatric Anxiety Inventory (GAI) consists of 20 questions answered with "yes" or "no". The GAI score is the sum of all answers, with higher scores indicating the presence of anxiety.

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

  10. Brief 2-Way Social Support Scale (SSS)

    The Brief 2-Way Social Support Scale (SSS) consists of 12 items to measure four dimensions of social support (giving emotional support, receiving emotional support, giving instrumental support, and receiving instrumental support). Each item is scored on a 6-point Likert scale ranging from "never" to "always".

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

  11. 6-item De Jong Gierveld Loneliness Scale (DJGLS-6)

    The 6-item De Jong Gierveld Loneliness Scale (DJGLS-6) has three statements about emotional loneliness (items 1, 2, and 3) and three statements about social loneliness (items 4, 5, and 6). Each item is scored with "yes", "more or less", and "no". In items 1, 2, and 3, "yes" and "more or less" are classified with 1 and "no" with 0. In items 4, 5, and 6, yes" is classified with 0, and "more or less" and "no" are classified with 1. The DJGLS-6 score ranges from 0 to 6, with lower scores indicating "least lonely".

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

  12. Health-Related Quality of Life 36-Item Short Form Survey (SF-36)

    The SF-36 consists of 36 items to assess physical (4 scales: physical functioning, role-physical, bodily pain, and general health) and mental health (4 scales: vitality, social functioning, role-emotional, and emotional well-being). First, each item is scored with a Likert scale or "yes" or "no" answers. Afterward, each item is rated on a scale of 0 to 100. The higher the scores in each scale, the higher the perception of health-related quality of life.

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

  13. Falls

    The number of falls during the intervention will be registered.

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

  14. Recruitment, Retention, and Adherence Rates (Feasibility)

    The recruitment, retention, and adherence rates will be calculated to analyze the feasibility of the intervention.

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

  15. Incidence of Adverse Events during Intervention (Safety)

    The number of adverse events (an undesirable outcome during the intervention that may or may not be related to it) will be registered.

    Measured: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

Timeline

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

  1. First posted6 Feb 2025
  2. Study start1 Jun 2025
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06812286
Sponsor's protocol ID
LCF/PR/SR24/57010031
Other IDs
LCF/PR/SR24/57010031, UIDB/04045/2020
Acronym
TrackFrailty
Status last verified
Aug 2025
First submitted
10 Jan 2025
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Less-volume and More-volume in people with Frailty Syndrome, run by University of Beira Interior at 6 sites 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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

Frailty phenotype (time frame: Baseline and after 10, 20, and 30 weeks of intervention (4 time points).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Aug 2025.

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