TrackFrailty Project

NCT06812286 | Active Not Recruiting

• 2 other identifiers: LCF/PR/SR24/57010031UIDB/04045/2020
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 6

Brief 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 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.

Conditions

Frailty Syndrome

Keywords

Muscle Strength; Functional Performance; Cognitive Impairment; Depression; Anxiety; Social Support; Quality of Life; Resistance Training; Exercise; Nursing Homes; Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Short Physical Performance Battery (SPPB)

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

• 10-meter walking test

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

• 6-minute walking test

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

• Handgrip strength

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

• 1-kg medicine ball throw

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

Study Arms (3)

Less-volume

EXPERIMENTAL

Three 10-week strength training cycles.

Other: Less-volume

More-volume

EXPERIMENTAL

Three 10-week strength training cycles.

Other: More-volume

Control

OTHER

Stretching exercises.

Other: Control

Interventions

Less-volume OTHER

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.

Less-volume

More-volume OTHER

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.

More-volume

Control OTHER

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

Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Beira Interior: lead
• Research Center in Sports Sciences, Health Sciences and Human Development: collaborator
• Health Sciences Research Centre (CICS-UBI): collaborator
• Reference Center for Active and Healthy Aging of the Interior Center Region (AgeINfuture): collaborator
• Universidad Pública de Navarra: collaborator
• NavarraBiomed Biomedical Research Center: collaborator

Study Sites (6)

Santa Casa da Misericórdia da Covilhã

Covilha, Castelo Branco District, 6200-082, Portugal

Location

Centro Social Nossa Senhora da Conceição

Covilha, Castelo Branco District, 6200-236, Portugal

Location

Lar de São José

Covilha, Castelo Branco District, 6200-352, Portugal

Location

Associação Centro Social Sagrado Coração Maria

Covilha, Castelo Branco District, 6200-571, Portugal

Location

Santa Casa da Misericórdia do Fundão

Fundão, Castelo Branco District, 6230-338, Portugal

Location

Centro Social Vales do Rio

Covilha, Cas, 6200-811, Portugal

Location

MeSH Terms

Conditions

Frailty; Cognitive Dysfunction; Depression; Anxiety Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Mário C Marques, PhD

  University of Beira Interior

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A statistician blinded to group allocation and the identity of the participants will analyze the data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 6, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (6)