Frail ElderlyFRAIL-ALAMANCT07572851
Functional Changes and Fall Risk in Older Adults Participating in a Frailty Program
An observational study of Frail Elderly and Fall Risk, run by University of Vigo at 1 site in Spain.
Trial summary
This prospective observational study aims to describe changes in physical function and fall risk in adults aged 70 years and older participating in a routine multicomponent frailty and falls prevention program in primary care. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frail Elderly, Fall Risk
- What is being tested?
- Multicomponent Exercise Program- 1 times per week. and Multicomponent Exercise Program- 2 times per week.
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 2 Apr 2026to 1 Jun 2026
- Phase
- Observational
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population consists of older adults aged 70 years and above who are currently enrolled in the frailty prevention program within the Galician public health system. These individuals have been identified as frail or pre-frail through routine primary care screening and demonstrate sufficient functional capacity, as indicated by a Barthel Index score of 90 or higher, reflecting independence in basic activities of daily living. Eligible participants must be able to understand the study procedures and provide informed consent, ensuring that they can engage safely and meaningfully in the intervention. All participants are actively involved in the structured frailty program delivered by primary care physiotherapy services, which focuses on preventing functional decline and reducing the risk of falls. Individuals will be excluded if they present with any medical contraindication to exercise.
Who may be able to join
- Age ≥70 years
- Barthel Index ≥90
- Participation in the frailty program
- Ability to provide informed consent
Who cannot join
- Medical contraindication to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of Functional Changes and Fall Risk in Older Adults Participating in a Multicomponent Frailty and Falls Prevention Program in Primary Care
This prospective observational study aims to describe changes in physical function and fall risk in adults aged 70 years and older participating in a routine multicomponent frailty and falls prevention program in primary care. Participants are evaluated before and after the intervention, and additional postural control variables are recorded using a pressure platform without modifying routine clinical care.
Read the detailed description
Frailty is a clinical condition associated with increased vulnerability to adverse health outcomes, including falls, disability, and mortality. In the Galician public health system, a structured frailty and falls prevention program is implemented within primary care physiotherapy services.
This study is designed as a prospective, longitudinal observational study with pre-post evaluation under real-world clinical conditions, without modifying clinical decision-making or healthcare organization.
Participants aged 70 years and older enrolled in the routine program undergo baseline (T0) and post-intervention (T1) assessments after 8 weeks. The intervention consists of a multicomponent exercise program including strength, balance, and functional training.
The primary objective is to describe changes in physical function and fall risk. Secondary objectives include the characterization of participants, analysis of adherence, recording of adverse events, and evaluation of the feasibility and utility of pressure-platform-based balance assessment.
Additional functional variables (muscle strength, aerobic capacity, and clinical balance tests) are included as part of the standardized functional assessment protocol implemented in routine care.
- Conditions
- Frail Elderly, Fall Risk
- Being tested
- Multicomponent Exercise Program- 1 times per week., Multicomponent Exercise Program- 2 times per week.
- Keywords
- Frailty, Falls prevention, Older adults, Physical function, SPPB, Sit-to-Stand, Primary care physiotherapy
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Exercise Program- 1 times per week.Other
Group-based therapeutic exercise program lasting 8 weeks, including strength, functional, and aerobic training, delivered 1 times per week.
Multicomponent Exercise Program- 2 times per week.Other
Group-based therapeutic exercise program lasting 8 weeks, including strength, functional, and aerobic training, delivered 2 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Frailty Program Participants- 1 day/week exercise program | Adults aged ≥70 years with preserved basic functional independence (Barthel Index ≥90) participating in a routine multicomponent exercise program for frailty and fall prevention in primary care. The participants of this group will attend one multicomponent exercise session per week Receives: Other: Multicomponent Exercise Program- 1 times per week. | |
| Frailty Program Participants- 2 day/week exercise program | Adults aged ≥70 years with preserved basic functional independence (Barthel Index ≥90) participating in a routine multicomponent exercise program for frailty and fall prevention in primary care. The participants of this group will attend two multicomponent exercise session per week Receives: Other: Multicomponent Exercise Program- 2 times per week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Performance Short Physical Performance Battery (SPPB)
Change in Short Physical Performance Battery (SPPB) total score. The SPPB is a composite measure of lower extremity function including balance, gait speed, and chair stand tests.
- Score range: 0 to 12
- Interpretation: Higher scores indicate better physical performance
- Unit of measure: Points on a scale
Measured: Baseline (T0) and post-intervention (8-12 weeks)
Change in Fall Risk
Change in fall risk indicators based on clinical assessment (falls history and gait impairment).
Minimum value: 0 Maximum value: Not applicable (composite clinical indicator; upper bound not fixed) Interpretation: Higher values indicate worse outcome (greater fall risk)
Measured: Baseline (T0) and post-intervention (8-12 weeks)
Change in Instrumented Balance: Center of Pressure (CoP) Sway Area
-Change in Center of Pressure (CoP) Sway Area
Change in postural sway area measured using a pressure platform. The Center of Pressure (CoP) sway area represents the area covered by the CoP trajectory during quiet standing.
Unit of measure: square millimeters (mm²). Higher values indicate worse postural stability.
Minimum value: 0 mm² Maximum value: Not applicable (no fixed upper limit) Interpretation: Higher values indicate worse postural stability
Measured: Baseline (T0) and post-intervention (8-12 weeks)
Change in Instrumented Balance: Center of Pressure (CoP) Velocity
Change in Center of Pressure (CoP) Velocity Change in mean velocity of center of pressure displacement.
- Unit of measure: mm/s
Minimum value: 0 mm/s Maximum value: Not applicable (no fixed upper limit) Interpretation: Higher values indicate worse postural stability
Measured: Baseline (T0) and post-intervention (8-12 weeks)
Change in Instrumented Balance:Center of Pressure (CoP) Path Length.
Change in Center of Pressure (CoP) Path Length Change in total trajectory length of center of pressure.
- Unit of measure: mm
Minimum value: 0 mm Maximum value: Not applicable (no fixed upper limit) Interpretation: Higher values indicate worse postural stability
Measured: Baseline (T0) and post-intervention (8-12 weeks)
Secondary outcomes (7)
Functional Performance: Change in Timed Up and Go (TUG) Test
Time required to stand up, walk 3 meters, turn, return, and sit down.
- Unit of measure: Seconds
- Interpretation: Lower values indicate better performance
The interpretation of TUG results depends on the population (healthy adults, older adults, clinical populations), but general reference thresholds are as follows:
- Older Adults (Community-Dwelling) < 12 seconds: Normal functional mobility 12-20 seconds: Mild impairment / increased risk of functional decline > 20 seconds: Significant mobility impairment
- Fall Risk Interpretation > 13.5 seconds: Increased risk of falls (commonly used cut-off)
Clinical Populations (frail patients) 20-30 seconds: Moderate functional limitation > 30 seconds: Severe dependency in mobility
A change of approximately ≥ 2-3 seconds is often considered clinically meaningful, depending on the population studied.
Measured: Baseline (T0) and post-intervention (8-12 weeks)
Functional Performance: Change in Gait Speed (4-Meter Walk Test)
Change in usual walking speed assessed over a 4-meter distance. Gait speed is calculated as distance divided by time and expressed in meters per second (m/s).
Only gait speed is reported as the outcome measure. Unit of measure: meters per second (m/s). Higher values indicate better functional performance.
Minimum value: 0 m/s Maximum value: Not applicable (no fixed upper limit; typically < 2.5 m/s in adults) Interpretation: Higher values indicate better functional performance
Measured: Baseline (T0) and post-intervention (8-12 weeks)
Functional Performance: Change in FRAIL Scale Score
Assessment of frailty status using the FRAIL scale.
- Score range: 0 to 5
- Interpretation: Higher scores indicate greater frailty
- Unit of measure: Points on a scale
Measured: Baseline (T0) and post-intervention (8-12 weeks)
Muscle Strength: Change in Handgrip Strength
Assessment of maximal isometric grip strength using a dynamometer.
- Unit of measure: kg (or Newtons, depending on device)
- Interpretation: Higher values indicate greater strength
Measured: Baseline (T0) and post-intervention (8-12 weeks)
Muscle Strength: Change in 30-Second Sit-to-Stand Test
- Unit of measure: Repetitions
- Interpretation: Higher values indicate better lower limb strength
Measured: Baseline (T0) and post-intervention (8-12 weeks)
Balance
Unipodal stance or Functional Reach Test
Measured: Baseline (T0) and post-intervention (8-12 weeks)
Aerobic Capacity
2-Minute Step Test
Measured: Baseline (T0) and post-intervention (8-12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start2 Apr 2026
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Antonio Justo Cousino, PhD, University of Vigo
- Investigators
- Lorenzo Justo-Cousiño, PhD, Principal investigator, Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Pontevedra, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572851
- Sponsor's protocol ID
- 025/447
- Acronym
- FRAIL-ALAMA
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Protocol states data will not be shared with third parties
Publications
Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.
PubMed 31343601Beckwee D, Delaere A, Aelbrecht S, Baert V, Beaudart C, Bruyere O, de Saint-Hubert M, Bautmans I. Exercise Interventions for the Prevention and Treatment of Sarcopenia. A Systematic Umbrella Review. J Nutr Health Aging. 2019;23(6):494-502. doi: 10.1007/s12603-019-1196-8.
PubMed 31233069Chittrakul J, Siviroj P, Sungkarat S, Sapbamrer R. Multi-System Physical Exercise Intervention for Fall Prevention and Quality of Life in Pre-Frail Older Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Apr 29;17(9):3102. doi: 10.3390/ijerph17093102.
PubMed 32365613Sato R, Vatic M, Peixoto da Fonseca GW, Anker SD, von Haehling S. Biological basis and treatment of frailty and sarcopenia. Cardiovasc Res. 2024 Jul 31;120(9):982-998. doi: 10.1093/cvr/cvae073.
PubMed 38828887Izquierdo M, Merchant RA, Morley JE, Anker SD, Aprahamian I, Arai H, Aubertin-Leheudre M, Bernabei R, Cadore EL, Cesari M, Chen LK, de Souto Barreto P, Duque G, Ferrucci L, Fielding RA, Garcia-Hermoso A, Gutierrez-Robledo LM, Harridge SDR, Kirk B, Kritchevsky S, Landi F, Lazarus N, Martin FC, Marzetti E, Pahor M, Ramirez-Velez R, Rodriguez-Manas L, Rolland Y, Ruiz JG, Theou O, Villareal DT, Waters DL, Won Won C, Woo J, Vellas B, Fiatarone Singh M. International Exercise Recommendations in Older Adults (ICFSR): Expert Consensus Guidelines. J Nutr Health Aging. 2021;25(7):824-853. doi: 10.1007/s12603-021-1665-8.
PubMed 34409961Allison R 2nd, Assadzandi S, Adelman M. Frailty: Evaluation and Management. Am Fam Physician. 2021 Feb 15;103(4):219-226.
PubMed 33587574Vazquez-Guajardo M, Rivas D, Duque G. Exercise as a Therapeutic Tool in Age-Related Frailty and Cardiovascular Disease: Challenges and Strategies. Can J Cardiol. 2024 Aug;40(8):1458-1467. doi: 10.1016/j.cjca.2024.01.005. Epub 2024 Jan 10.
PubMed 38215969Yang X, Li S, Xu L, Liu H, Li Y, Song X, Bao J, Liao S, Xi Y, Guo G. Effects of multicomponent exercise on frailty status and physical function in frail older adults: A meta-analysis and systematic review. Exp Gerontol. 2024 Nov;197:112604. doi: 10.1016/j.exger.2024.112604. Epub 2024 Oct 21.
PubMed 39426607Sadjapong U, Yodkeeree S, Sungkarat S, Siviroj P. Multicomponent Exercise Program Reduces Frailty and Inflammatory Biomarkers and Improves Physical Performance in Community-Dwelling Older Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 May 26;17(11):3760. doi: 10.3390/ijerph17113760.
PubMed 32466446Dent E, Daly RM, Hoogendijk EO, Scott D. Exercise to Prevent and Manage Frailty and Fragility Fractures. Curr Osteoporos Rep. 2023 Apr;21(2):205-215. doi: 10.1007/s11914-023-00777-8. Epub 2023 Mar 28.
PubMed 36976491Angulo J, El Assar M, Alvarez-Bustos A, Rodriguez-Manas L. Physical activity and exercise: Strategies to manage frailty. Redox Biol. 2020 Aug;35:101513. doi: 10.1016/j.redox.2020.101513. Epub 2020 Mar 20.
PubMed 32234291Lee JE, Chun H, Kim YS, Jung HW, Jang IY, Cha HM, Son KY, Cho B, Kwon IS, Yoon JL. Association between Timed Up and Go Test and Subsequent Functional Dependency. J Korean Med Sci. 2020 Jan 20;35(3):e25. doi: 10.3346/jkms.2020.35.e25.
PubMed 31950779Choi JY, Park JW, Kim KI, Lee YK, Kim CH. Prediction of 5-Year Survival Rate After Hip Fracture Surgery Using a Comprehensive Geriatric Assessment-Based Frailty Score Model. J Korean Med Sci. 2025 Mar 31;40(12):e40. doi: 10.3346/jkms.2025.40.e40.
PubMed 40165573Kim KJ, Lee SB, Kim CO. How to Assess Frailty: Role of Comprehensive Geriatric Assessment. J Korean Med Sci. 2020 Jan 20;35(3):e34. doi: 10.3346/jkms.2020.35.e34. No abstract available.
PubMed 31950780Lee H, Lee E, Jang IY. Frailty and Comprehensive Geriatric Assessment. J Korean Med Sci. 2020 Jan 20;35(3):e16. doi: 10.3346/jkms.2020.35.e16.
PubMed 31950775
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Functional Changes and Fall Risk in Older Adults Participating in a Multicomponent Frailty and Falls Prevention Program in Primary Care
- ClinicalTrials.gov ID
- NCT07572851
- Acronym / sponsor ID
- FRAIL-ALAMA / 025/447
- Conditions
- Frail Elderly, Fall Risk
- Keywords
- Frailty, Falls prevention, Older adults, Physical function, SPPB, Sit-to-Stand, Primary care physiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 7 May 2026 (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.
This prospective observational study aims to describe changes in physical function and fall risk in adults aged 70 years and older participating in a routine multicomponent frailty and falls prevention program in primary care. Participants are evaluated before and after the intervention, and additional postural control variables are recorded using a pressure platform without modifying routine clinical care.
Detailed description
Frailty is a clinical condition associated with increased vulnerability to adverse health outcomes, including falls, disability, and mortality. In the Galician public health system, a structured frailty and falls prevention program is implemented within primary care physiotherapy services.
This study is designed as a prospective, longitudinal observational study with pre-post evaluation under real-world clinical conditions, without modifying clinical decision-making or healthcare organization.
Participants aged 70 years and older enrolled in the routine program undergo baseline (T0) and post-intervention (T1) assessments after 8 weeks. The intervention consists of a multicomponent exercise program including strength, balance, and functional training.
The primary objective is to describe changes in physical function and fall risk. Secondary objectives include the characterization of participants, analysis of adherence, recording of adverse events, and evaluation of the feasibility and utility of pressure-platform-based balance assessment.
Additional functional variables (muscle strength, aerobic capacity, and clinical balance tests) are included as part of the standardized functional assessment protocol implemented in routine care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frailty Program Participants- 1 day/week exercise program | – | Other: Multicomponent Exercise Program- 1 times per week.Adults aged ≥70 years with preserved basic functional independence (Barthel Index ≥90) participating in a routine multicomponent exercise program for frailty and fall prevention in primary care. The participants of this group will attend one multicomponent exercise session per week |
| Frailty Program Participants- 2 day/week exercise program | – | Other: Multicomponent Exercise Program- 2 times per week.Adults aged ≥70 years with preserved basic functional independence (Barthel Index ≥90) participating in a routine multicomponent exercise program for frailty and fall prevention in primary care. The participants of this group will attend two multicomponent exercise session per week |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population consists of older adults aged 70 years and above who are currently enrolled in the frailty prevention program within the Galician public health system. These individuals have been identified as frail or pre-frail through routine primary care screening and demonstrate sufficient functional capacity, as indicated by a Barthel Index score of 90 or higher, reflecting independence in basic activities of daily living. Eligible participants must be able to understand the study procedures and provide informed consent, ensuring that they can engage safely and meaningfully in the intervention. All participants are actively involved in the structured frailty program delivered by primary care physiotherapy services, which focuses on preventing functional decline and reducing the risk of falls. Individuals will be excluded if they present with any medical contraindication to exercise.
Key inclusion criteria (4 listed)
- Age ≥70 years
- Barthel Index ≥90
- Participation in the frailty program
- Ability to provide informed consent
Key exclusion criteria (1 listed)
- Medical contraindication to exercise
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 |
|---|---|---|
| Multicomponent Exercise Program- 1 times per week.Group-based therapeutic exercise program lasting 8 weeks, including strength, functional, and aerobic training, delivered 1 times per week. | Other | Frailty Program Participants- 1 day/week exercise program |
| Multicomponent Exercise Program- 2 times per week.Group-based therapeutic exercise program lasting 8 weeks, including strength, functional, and aerobic training, delivered 2 times per week. | Other | Frailty Program Participants- 2 day/week exercise program |
Primary outcome
Change in Physical Performance Short Physical Performance Battery (SPPB)
Time frame: Baseline (T0) and post-intervention (8-12 weeks)
Change in Short Physical Performance Battery (SPPB) total score. The SPPB is a composite measure of lower extremity function including balance, gait speed, and chair stand tests. * Score range: 0 to 12 * Interpretation: Higher scores indicate better physical performance * Unit of measure: Points on a scale
Change in Fall Risk
Time frame: Baseline (T0) and post-intervention (8-12 weeks)
Change in fall risk indicators based on clinical assessment (falls history and gait impairment). Minimum value: 0 Maximum value: Not applicable (composite clinical indicator; upper bound not fixed) Interpretation: Higher values indicate worse outcome (greater fall risk)
Change in Instrumented Balance: Center of Pressure (CoP) Sway Area
Time frame: Baseline (T0) and post-intervention (8-12 weeks)
-Change in Center of Pressure (CoP) Sway Area Change in postural sway area measured using a pressure platform. The Center of Pressure (CoP) sway area represents the area covered by the CoP trajectory during quiet standing. Unit of measure: square millimeters (mm²). Higher values indicate worse postural stability. Minimum value: 0 mm² Maximum value: Not applicable (no fixed upper limit) Interpretation: Higher values indicate worse postural stability
Change in Instrumented Balance: Center of Pressure (CoP) Velocity
Time frame: Baseline (T0) and post-intervention (8-12 weeks)
Change in Center of Pressure (CoP) Velocity Change in mean velocity of center of pressure displacement. • Unit of measure: mm/s Minimum value: 0 mm/s Maximum value: Not applicable (no fixed upper limit) Interpretation: Higher values indicate worse postural stability
Change in Instrumented Balance:Center of Pressure (CoP) Path Length.
Time frame: Baseline (T0) and post-intervention (8-12 weeks)
Change in Center of Pressure (CoP) Path Length Change in total trajectory length of center of pressure. • Unit of measure: mm Minimum value: 0 mm Maximum value: Not applicable (no fixed upper limit) Interpretation: Higher values indicate worse postural stability
7 secondary outcomes
Functional Performance: Change in Timed Up and Go (TUG) Test
Time frame: Baseline (T0) and post-intervention (8-12 weeks)
Functional Performance: Change in Gait Speed (4-Meter Walk Test)
Time frame: Baseline (T0) and post-intervention (8-12 weeks)
Functional Performance: Change in FRAIL Scale Score
Time frame: Baseline (T0) and post-intervention (8-12 weeks)
Muscle Strength: Change in Handgrip Strength
Time frame: Baseline (T0) and post-intervention (8-12 weeks)
Muscle Strength: Change in 30-Second Sit-to-Stand Test
Time frame: Baseline (T0) and post-intervention (8-12 weeks)
Balance
Time frame: Baseline (T0) and post-intervention (8-12 weeks)
Aerobic Capacity
Time frame: Baseline (T0) and post-intervention (8-12 weeks)
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 23 Sep 2026.
- Background: PubMed 31343601Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.
- Background: PubMed 31233069Beckwee D, Delaere A, Aelbrecht S, Baert V, Beaudart C, Bruyere O, de Saint-Hubert M, Bautmans I. Exercise Interventions for the Prevention and Treatment of Sarcopenia. A Systematic Umbrella Review. J Nutr Health Aging. 2019;23(6):494-502. doi: 10.1007/s12603-019-1196-8.
- Background: PubMed 32365613Chittrakul J, Siviroj P, Sungkarat S, Sapbamrer R. Multi-System Physical Exercise Intervention for Fall Prevention and Quality of Life in Pre-Frail Older Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Apr 29;17(9):3102. doi: 10.3390/ijerph17093102.
- Background: PubMed 38828887Sato R, Vatic M, Peixoto da Fonseca GW, Anker SD, von Haehling S. Biological basis and treatment of frailty and sarcopenia. Cardiovasc Res. 2024 Jul 31;120(9):982-998. doi: 10.1093/cvr/cvae073.
- Background: PubMed 34409961Izquierdo M, Merchant RA, Morley JE, Anker SD, Aprahamian I, Arai H, Aubertin-Leheudre M, Bernabei R, Cadore EL, Cesari M, Chen LK, de Souto Barreto P, Duque G, Ferrucci L, Fielding RA, Garcia-Hermoso A, Gutierrez-Robledo LM, Harridge SDR, Kirk B, Kritchevsky S, Landi F, Lazarus N, Martin FC, Marzetti E, Pahor M, Ramirez-Velez R, Rodriguez-Manas L, Rolland Y, Ruiz JG, Theou O, Villareal DT, Waters DL, Won Won C, Woo J, Vellas B, Fiatarone Singh M. International Exercise Recommendations in Older Adults (ICFSR): Expert Consensus Guidelines. J Nutr Health Aging. 2021;25(7):824-853. doi: 10.1007/s12603-021-1665-8.
- Background: PubMed 33587574Allison R 2nd, Assadzandi S, Adelman M. Frailty: Evaluation and Management. Am Fam Physician. 2021 Feb 15;103(4):219-226.
- Background: PubMed 38215969Vazquez-Guajardo M, Rivas D, Duque G. Exercise as a Therapeutic Tool in Age-Related Frailty and Cardiovascular Disease: Challenges and Strategies. Can J Cardiol. 2024 Aug;40(8):1458-1467. doi: 10.1016/j.cjca.2024.01.005. Epub 2024 Jan 10.
- Background: PubMed 39426607Yang X, Li S, Xu L, Liu H, Li Y, Song X, Bao J, Liao S, Xi Y, Guo G. Effects of multicomponent exercise on frailty status and physical function in frail older adults: A meta-analysis and systematic review. Exp Gerontol. 2024 Nov;197:112604. doi: 10.1016/j.exger.2024.112604. Epub 2024 Oct 21.
- Background: PubMed 32466446Sadjapong U, Yodkeeree S, Sungkarat S, Siviroj P. Multicomponent Exercise Program Reduces Frailty and Inflammatory Biomarkers and Improves Physical Performance in Community-Dwelling Older Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 May 26;17(11):3760. doi: 10.3390/ijerph17113760.
- Background: PubMed 36976491Dent E, Daly RM, Hoogendijk EO, Scott D. Exercise to Prevent and Manage Frailty and Fragility Fractures. Curr Osteoporos Rep. 2023 Apr;21(2):205-215. doi: 10.1007/s11914-023-00777-8. Epub 2023 Mar 28.
- Background: PubMed 32234291Angulo J, El Assar M, Alvarez-Bustos A, Rodriguez-Manas L. Physical activity and exercise: Strategies to manage frailty. Redox Biol. 2020 Aug;35:101513. doi: 10.1016/j.redox.2020.101513. Epub 2020 Mar 20.
- Background: PubMed 31950779Lee JE, Chun H, Kim YS, Jung HW, Jang IY, Cha HM, Son KY, Cho B, Kwon IS, Yoon JL. Association between Timed Up and Go Test and Subsequent Functional Dependency. J Korean Med Sci. 2020 Jan 20;35(3):e25. doi: 10.3346/jkms.2020.35.e25.
- World Health Organization. World report on ageing and health. Geneva: World Health Organization; 2015.Link provided by the sponsor.
- European Commission. The European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) \[Internet\]. Brussels: European CommissionLink provided by the sponsor.
- Consejo General de Colegios de Fisioterapia de España. Libro Blanco: Fisioterapia y Fragilidad. 2025Link provided by the sponsor.
- Dirección Xeral de Asistencia Sanitaria. Servizo Galego de Saúde. Carteira de Servizos de Fisioterapia de Atencion Primaria e Comunitaria do Servizo Galego de Saúde. 2023Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Protocol states data will not be shared with third parties
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Frail Elderly, Frailty
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.
Lorenzo Justo-Cousiño, PhD principal investigator
Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Pontevedra, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly and Fall Risk, run by University of Vigo at 1 site in Spain.
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 4 inclusion and 1 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 23 Sep 2026. 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 Spain. 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 in Physical Performance Short Physical Performance Battery (SPPB) (time frame: Baseline (T0) and post-intervention (8-12 weeks)). The study lists 5 primary outcomes in all. 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 NCT07572851, which also lists 23 linked publications.
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 23 Sep 2026.