TrackFrailty Project (TrackFrailty)

TrackFrailty: Track to Prevent, Mitigate, and Reverse Frailty

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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Frailty Syndrome
• Intervention / Treatment: Other: Less-volume; Other: More-volume; Other: Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Cas
    • Covilha, Cas, Portugal, 6200-811
      • Centro Social Vales do Rio
  • Castelo Branco District
    • Covilha, Castelo Branco District, Portugal, 6200-082
      • Santa Casa da Misericórdia da Covilhã
    • Covilha, Castelo Branco District, Portugal, 6200-236
      • Centro Social Nossa Senhora da Conceição
    • Covilha, Castelo Branco District, Portugal, 6200-352
      • Lar de São José
    • Covilha, Castelo Branco District, Portugal, 6200-571
      • Associação Centro Social Sagrado Coração Maria
    • Fundão, Castelo Branco District, Portugal, 6230-338
      • Santa Casa da Misericórdia do Fundão

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Less-volume; Three 10-week strength training cycles.	Other: Less-volume; 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.
Experimental: More-volume; Three 10-week strength training cycles.	Other: More-volume; 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.
Other: Control; Stretching exercises.	Other: Control; Participants in the control group will undergo sham training twice weekly for 30 weeks, consisting of stretching exercises supervised by two exercise physiologists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty phenotype	Fried's criteria will be used to assess frailty (unintentional weight loss, exhaustion, low physical activity, slowness, and muscle weakness).	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).
10-meter walking test	Participants will walk 10 m in a linear path, and time (s) will be measured.	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).
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.	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).
Handgrip strength	A handheld dynamometer will be used to measure handgrip strength (seated position).	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).
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.	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).
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).	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).
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).	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).
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.	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).
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.	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).
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".	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).
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".	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).
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.	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).
Falls	The number of falls during the intervention will be registered.	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).
Recruitment, Retention, and Adherence Rates (Feasibility)	The recruitment, retention, and adherence rates will be calculated to analyze the feasibility of the intervention.	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).
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.	Baseline and after 10, 20, and 30 weeks of intervention (4 time points).

Collaborators and Investigators

• Sponsor: University of Beira Interior
• Collaborators: Universidad Pública de Navarra; NavarraBiomed Biomedical Research Center; Research Center in Sports Sciences, Health Sciences and Human Development; Health Sciences Research Centre (CICS-UBI); Reference Center for Active and Healthy Aging of the Interior Center Region (AgeINfuture)
• Investigators: Principal Investigator: Mário C Marques, PhD, University of Beira Interior

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: February 1, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Exercise; Quality of Life; Anxiety; Cognitive Impairment; Aging; Muscle Strength; Resistance Training; Social Support; Functional Performance; Nursing Homes
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Behavioral Symptoms; Neurocognitive Disorders; Cognition Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Frailty; Anxiety Disorders; Cognitive Dysfunction; Depression; Motor Activity
• Other Study ID Numbers: LCF/PR/SR24/57010031 (Other Grant/Funding Number: "la Caixa" Foundation); UIDB/04045/2020 (Other Grant/Funding Number: Portuguese Foundation for Science and Technology (FCT))

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
• product manufactured in and exported from the U.S.: No