FrailtyFRACTEP-65NCT07132632
Effect of a Multicomponent Therapeutic Exercise Program in Primary Care on Frailty and Sarcopenia in Older Adults
A study testing 12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, balance, mobility, and aerobic capacity in people with Frailty and Sarcopenia, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
Trial summary
Background: Frailty and sarcopenia are common conditions in older adults that increase the risk of disability, dependence, and hospitalizations. Frailty is characterized by decreased physiological reserve and functional capacity, while sarcopenia refers to the loss of muscle mass, strength, and performance. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Sarcopenia, Aging
- What is being tested?
- 12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, balance, mobility, and aerobic capacity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2025to 31 Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adults aged 65 years or older, receiving care from primary care physiotherapists at participating health centers.
- Clinical Frailty Scale (CFS) score between 4 and 6 (indicating vulnerable, mild, or moderate frailty).
- Ability to walk independently, with or without assistive devices (excluding habitual wheelchair use).
- Clinically stable, defined as the absence of acute events or clinical decompensation in the previous 4 weeks.
- Sufficient cognitive ability to understand and follow basic instructions, or the availability of an actively involved caregiver (MMSE ≥ 20 or equivalent).
- Signed informed consent from the participant or their legal representative.
Who cannot join
- Diagnosis of severe frailty or advanced dependence (CFS ≥ 7).
- Severe neurological or musculoskeletal disorders that limit safe exercise participation (e.g., Parkinson's disease, stroke with major sequelae, disabling arthropathies).
- Uncontrolled cardiac, respiratory, or other medical conditions that contraindicate physical activity.
- Moderate to severe cognitive impairment, defined by MMSE < 20 or a clinical diagnosis of dementia with significant functional limitations.
- Simultaneous participation in other structured physical intervention programs.
About this study
Background:
Frailty and sarcopenia are common conditions in older adults that increase the risk of disability, dependence, and hospitalizations. Frailty is characterized by decreased physiological reserve and functional capacity, while sarcopenia refers to the loss of muscle mass, strength, and performance. Both conditions are prevalent among older adults and represent a growing public health challenge as the population ages.
Read more
Objective:
This study aims to evaluate the effectiveness of a multicomponent therapeutic exercise program in reducing frailty and improving clinical parameters related to sarcopenia in community-dwelling older adults aged 65 years or older who attend primary care centers.
Study Design:
This is a quasi-experimental, multicenter, single-group pre-post clinical trial. The study includes two phases: a control phase (pre-intervention observation) and an experimental phase (intervention). Each participant will act as their own control.
Participants:
60 older adults aged 65 or older will be recruited from primary care centers in the Baix Llobregat region (Catalonia, Spain). Eligibility criteria include mild to moderate frailty (Clinical Frailty Scale 4-6), ability to walk independently (with or without a walking aid), cognitive ability to follow instructions (MMSE ≥ 20), and clinical stability. Exclusion criteria include severe frailty, major cognitive impairment, acute illness, or participation in another structured exercise program.
Intervention:
Participants will take part in a 12-week multicomponent exercise program including 8 supervised sessions at the primary care center and 4 home-based sessions. Each session will last 60 minutes and include strength training, balance exercises, aerobic activity, and flexibility. The program follows FITT-VP principles (frequency, intensity, time, type, volume, and progression). Home sessions will be supported with illustrated manuals and biweekly follow-up calls.
Outcomes:
The primary outcome is the change in frailty level measured by the Clinical Frailty Scale (CFS). Secondary outcomes include handgrip strength, SARC-F score, Short Physical Performance Battery (SPPB), 4-meter walk test, Timed Up and Go (TUG), muscle mass index, rectus femoris and vastus lateralis ultrasound, cognitive status (MMSE), nutritional status (MNA-SF), falls, and hospitalizations. Assessments will be conducted at baseline (month 0), after the control phase (month 3), and after the intervention (month 6).
Significance:
This study will provide evidence on the medium-term effectiveness of a short, structured, and feasible intervention implemented in real-life primary care settings. If effective, this program could be integrated into preventive strategies to reduce frailty and sarcopenia, promote autonomy, and improve the quality of life among older adults. Results will inform clinical guidelines and contribute to the development of scalable interventions for aging populations.
- Conditions
- Frailty, Sarcopenia, Aging, Exercises Therapy
- Being tested
- 12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, balance, mobility, and aerobic capacity, Placebo Pre-Treat
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, balance, mobility, and aerobic capacityBehavioural
This intervention consists of a 12-week multicomponent therapeutic exercise program for older adults with mild to moderate frailty. Participants will complete 12 sessions (8 supervised in primary care and 4 home-based), each lasting approximately 60 minutes. Sessions include warm-up, strength exercises (using body weight or elastic bands), moderate aerobic activity (e.g., walking or pedaling), balance and coordination training (including dual tasks), and a cool-down phase. The program follows FITT-VP principles and is tailored to functional capacity. Intensity is monitored using the Borg scale (CR10 and RPE), estimated 1RM (20-80%), and 64-76% HRmax. Exercises are progressively adjusted in volume, intensity, and complexity. Home sessions are guided by an illustrated manual and reinforced by biweekly follow-up phone calls to promote adherence and safety. The intervention is aligned with international guidelines and aims to improve physical performance, reduce frailty and sarcopenia.
Placebo Pre-TreatBehavioural
The pre-intervention period (Month 0 to Month 3) will serve as the control phase, during which participants will receive no specific exercise program. From Month 3 to Month 6, the intervention phase will begin. Participants act as their own control.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Multicomponent Exercise Intervention Receives: Behavioral: 12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, balance, mobility, and aerobic capacity |
| Control Arm | Placebo comparator | Not described Receives: Behavioral: Placebo Pre-Treat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Clinical Frailty Scale (CFS) Score at 6 Months
Clinical Frailty Scale (CFS) is a 9-point ordinal scale assessing functional and clinical status in older adults. A change of ≥0.5 points is considered clinically significant.
Measured: Baseline (Month 0) to Month 6
Secondary outcomes (12)
Baseline (Month 0) to Month 6
Handgrip strength measured using a Jamar® dynamometer. The average of three trials per hand will be used. A decrease indicates lower muscle strength, a key sarcopenia marker.
Measured: Baseline (Month 0) to Month 6
Change from Baseline in Short Physical Performance Battery (SPPB) Score at 6 Months
Composite score from balance tests, 4-meter gait speed, and chair rise test. Score ranges from 0 to 12, with ≤8 indicating poor physical performance.
Measured: Baseline (Month 0) to Month 6
Change from Baseline in Gait Speed (4-Meter Walk Test) at 6 Months
Average walking speed over 4 meters. Lower speeds (<0.8 m/s) are associated with higher frailty and fall risk.
Measured: Baseline (Month 0) to Month 6
Change from Baseline in Timed Up and Go (TUG) Test Performance at 6 Months
Time to rise from a chair, walk 3 meters, turn, return, and sit. Times ≥13.5 seconds indicate increased fall risk.
Measured: Baseline (Month 0) to Month 6
Change from Baseline in Estimated Skeletal Muscle Mass Index at 6 Months
Calculated using anthropometric data via Lee et al.'s validated formula.
Measured: Baseline (Month 0) to Month 6
Change in Rectus Femoris and Vastus Lateralis Muscle Thickness at 6 Months
Ultrasound-based assessment of muscle thickness and adipose tissue content in the dominant lower limb.
Measured: Baseline (Month 0) to Month 6
Change from Baseline in Mini Nutritional Assessment-Short Form (MNA-SF) Score at 6 Months
Nutrition screening tool (score 0-14). Categories: well-nourished (>11), at risk (8-11), malnourished (<8).
Measured: Baseline (Month 0) to Month 6
Change from Baseline in Mini-Mental State Examination (MMSE) Score at 6 Months
Cognitive status measured with MMSE (score 0-30). Scores <26 suggest cognitive impairment.
Measured: Baseline (Month 0) to Month 6
Number of Participants with Hospital Admissions During the Study Period
Self-reported or caregiver-reported data on hospitalizations.
Measured: Baseline (Month 0) to Month 6
Number of Participants Reporting Falls During the Study Period
Number of self-reported falls tracked throughout the study.
Measured: Baseline (Month 0) to Month 6
Adherence to Home-Based Exercise Sessions (Self-Reported Completion Rate)
Percentage of home-based sessions completed, based on self-records and phone follow-up.
Measured: Over the 12-week intervention
Self-Reported Enjoyment of Physical Activity (Likert Scale) at 6 Months
Degree of enjoyment assessed on a Likert scale from 1 (not enjoyable) to 5 (very enjoyable).
Measured: At Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start2 Nov 2025 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaiza Casas, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132632
- Sponsor's protocol ID
- IDIAP-FRAIL65
- Acronym
- FRACTEP-65
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Multicomponent Therapeutic Exercise Program in Primary Care on Frailty and Sarcopenia in Older Adults
- ClinicalTrials.gov ID
- NCT07132632
- Acronym / sponsor ID
- FRACTEP-65 / IDIAP-FRAIL65
- Conditions
- Frailty, Sarcopenia, Aging, Exercises Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 2 Nov 2025 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Aug 2025 (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.
Background:
Frailty and sarcopenia are common conditions in older adults that increase the risk of disability, dependence, and hospitalizations. Frailty is characterized by decreased physiological reserve and functional capacity, while sarcopenia refers to the loss of muscle mass, strength, and performance. Both conditions are prevalent among older adults and represent a growing public health challenge as the population ages.
Objective:
This study aims to evaluate the effectiveness of a multicomponent therapeutic exercise program in reducing frailty and improving clinical parameters related to sarcopenia in community-dwelling older adults aged 65 years or older who attend primary care centers.
Study Design:
This is a quasi-experimental, multicenter, single-group pre-post clinical trial. The study includes two phases: a control phase (pre-intervention observation) and an experimental phase (intervention). Each participant will act as their own control.
Participants:
60 older adults aged 65 or older will be recruited from primary care centers in the Baix Llobregat region (Catalonia, Spain). Eligibility criteria include mild to moderate frailty (Clinical Frailty Scale 4-6), ability to walk independently (with or without a walking aid), cognitive ability to follow instructions (MMSE ≥ 20), and clinical stability. Exclusion criteria include severe frailty, major cognitive impairment, acute illness, or participation in another structured exercise program.
Intervention:
Participants will take part in a 12-week multicomponent exercise program including 8 supervised sessions at the primary care center and 4 home-based sessions. Each session will last 60 minutes and include strength training, balance exercises, aerobic activity, and flexibility. The program follows FITT-VP principles (frequency, intensity, time, type, volume, and progression). Home sessions will be supported with illustrated manuals and biweekly follow-up calls.
Outcomes:
The primary outcome is the change in frailty level measured by the Clinical Frailty Scale (CFS). Secondary outcomes include handgrip strength, SARC-F score, Short Physical Performance Battery (SPPB), 4-meter walk test, Timed Up and Go (TUG), muscle mass index, rectus femoris and vastus lateralis ultrasound, cognitive status (MMSE), nutritional status (MNA-SF), falls, and hospitalizations. Assessments will be conducted at baseline (month 0), after the control phase (month 3), and after the intervention (month 6).
Significance:
This study will provide evidence on the medium-term effectiveness of a short, structured, and feasible intervention implemented in real-life primary care settings. If effective, this program could be integrated into preventive strategies to reduce frailty and sarcopenia, promote autonomy, and improve the quality of life among older adults. Results will inform clinical guidelines and contribute to the development of scalable interventions for aging populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: 12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, balance, mobility, and aerobic capacityMulticomponent Exercise Intervention |
| Control Arm | Placebo comparator | Behavioral: Placebo Pre-Treat |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Adults aged 65 years or older, receiving care from primary care physiotherapists at participating health centers.
- Clinical Frailty Scale (CFS) score between 4 and 6 (indicating vulnerable, mild, or moderate frailty).
- Ability to walk independently, with or without assistive devices (excluding habitual wheelchair use).
- Clinically stable, defined as the absence of acute events or clinical decompensation in the previous 4 weeks.
- Sufficient cognitive ability to understand and follow basic instructions, or the availability of an actively involved caregiver (MMSE ≥ 20 or equivalent).
Key exclusion criteria (5 listed)
- Diagnosis of severe frailty or advanced dependence (CFS ≥ 7).
- Severe neurological or musculoskeletal disorders that limit safe exercise participation (e.g., Parkinson's disease, stroke with major sequelae, disabling arthropathies).
- Uncontrolled cardiac, respiratory, or other medical conditions that contraindicate physical activity.
- Moderate to severe cognitive impairment, defined by MMSE < 20 or a clinical diagnosis of dementia with significant functional limitations.
- Simultaneous participation in other structured physical intervention programs.
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 |
|---|---|---|
| 12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, balance, mobility, and aerobic capacityThis intervention consists of a 12-week multicomponent therapeutic exercise program for older adults with mild to moderate frailty. Participants will complete 12 sessions (8 supervised in primary care and 4 home-based), each lasting approximately 60 minutes. Sessions include warm-up, strength exercises (using body weight or elastic bands), moderate aerobic activity (e.g., walking or pedaling), balance and coordination training (including dual tasks), and a cool-down phase. The program follows FITT-VP principles and is tailored to functional capacity. Intensity is monitored using the Borg scale (CR10 and RPE), estimated 1RM (20-80%), and 64-76% HRmax. Exercises are progressively adjusted in volume, intensity, and complexity. Home sessions are guided by an illustrated manual and reinforced by biweekly follow-up phone calls to promote adherence and safety. The intervention is aligned with international guidelines and aims to improve physical performance, reduce frailty and sarcopenia. | Behavioural | Arm 1 |
| Placebo Pre-TreatThe pre-intervention period (Month 0 to Month 3) will serve as the control phase, during which participants will receive no specific exercise program. From Month 3 to Month 6, the intervention phase will begin. Participants act as their own control. | Behavioural | Control Arm |
Primary outcome
Change from Baseline in Clinical Frailty Scale (CFS) Score at 6 Months
Time frame: Baseline (Month 0) to Month 6
Clinical Frailty Scale (CFS) is a 9-point ordinal scale assessing functional and clinical status in older adults. A change of ≥0.5 points is considered clinically significant.
12 secondary outcomes
Baseline (Month 0) to Month 6
Time frame: Baseline (Month 0) to Month 6
Change from Baseline in Short Physical Performance Battery (SPPB) Score at 6 Months
Time frame: Baseline (Month 0) to Month 6
Change from Baseline in Gait Speed (4-Meter Walk Test) at 6 Months
Time frame: Baseline (Month 0) to Month 6
Change from Baseline in Timed Up and Go (TUG) Test Performance at 6 Months
Time frame: Baseline (Month 0) to Month 6
Change from Baseline in Estimated Skeletal Muscle Mass Index at 6 Months
Time frame: Baseline (Month 0) to Month 6
Change in Rectus Femoris and Vastus Lateralis Muscle Thickness at 6 Months
Time frame: Baseline (Month 0) to Month 6
Change from Baseline in Mini Nutritional Assessment-Short Form (MNA-SF) Score at 6 Months
Time frame: Baseline (Month 0) to Month 6
Change from Baseline in Mini-Mental State Examination (MMSE) Score at 6 Months
Time frame: Baseline (Month 0) to Month 6
Number of Participants with Hospital Admissions During the Study Period
Time frame: Baseline (Month 0) to Month 6
Number of Participants Reporting Falls During the Study Period
Time frame: Baseline (Month 0) to Month 6
Adherence to Home-Based Exercise Sessions (Self-Reported Completion Rate)
Time frame: Over the 12-week intervention
Self-Reported Enjoyment of Physical Activity (Likert Scale) at 6 Months
Time frame: At Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, balance, mobility, and aerobic capacity in people with Frailty and Sarcopenia, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change from Baseline in Clinical Frailty Scale (CFS) Score at 6 Months (time frame: Baseline (Month 0) to Month 6). 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 27 Aug 2025.