Balance ImpairmentBASE-FrailNCT07686146
Multicomponent Exercise and Frailty in Nursing Home Residents
A study testing Multicomponent Exercise Program (BASE) in people with Balance Impairment and Sarcopenia in Elderly, run by Escoles Universitaries Gimbernat at 1 site in Spain.
Trial summary
Frailty is common among older adults living in nursing homes and increases the risk of falls, disability, and loss of independence. However, there is limited evidence on practical and feasible exercise programs adapted to this population. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Balance Impairment, Sarcopenia in Elderly, Frailty at Older Adults
- What is being tested?
- Multicomponent Exercise Program (BASE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 30 Nov 2021to 31 Dec 2022
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years or older
- Living in a nursing home
- Ability to walk at least 10 meters (with or without assistive devices)
- Mini-Mental State Examination (MMSE) score ≥19
Who cannot join
- Neurodegenerative diseases
- Advanced dementia
- Parkinson's disease
- Hemodynamic instability
- Lower limb fractures under rehabilitation within the past year
Trial locations and contacts
1 site in 1 country.
Spain1 site
Escoles Universitàries Gimbernat
Sant Cugat del Vallès, Barcelona, 08174
About this study
Official title: Effects of a Multicomponent Exercise Program on Frailty in Institutionalized Older Adults: A Multicenter Controlled Study
Frailty is common among older adults living in nursing homes and increases the risk of falls, disability, and loss of independence. However, there is limited evidence on practical and feasible exercise programs adapted to this population.
This study evaluated the effects of a multicomponent exercise program combining strength and balance training in residents aged 65 years and older. Participants were assigned to either an intervention group, which performed supervised exercise sessions twice a week for 8 weeks, or a control group, which continued their usual activities.
Read more
The main outcome was frailty, measured using the Short Physical Performance Battery. Other outcomes included balance, functional independence, sarcopenia, fear of falling, and number of falls.
This study was retrospectively registered.
Read the detailed description
Frailty is a multidimensional clinical condition highly prevalent among older adults living in institutional settings and is associated with increased risk of falls, disability, hospitalization, and mortality. Despite growing evidence supporting physical exercise interventions, there is still a need for structured, feasible, and clinically applicable programs specifically designed for nursing home residents.
This study aimed to evaluate the effects of a multicomponent exercise program on frailty and related outcomes in institutionalized older adults. A multicenter, controlled, non-randomized design was used, including participants recruited from eight nursing homes.
Participants aged 65 years and older were allocated by residential center to either an intervention group or a control group. The intervention group participated in the Balance and Strength Exercises (BASE) program, consisting of supervised sessions performed twice weekly for 8 weeks. Each session included a combination of strength and balance exercises with progressive levels adapted to individual capacity. The control group continued their usual care and routine activities.
The primary outcome was frailty, assessed using the Short Physical Performance Battery (SPPB). Secondary outcomes included balance, measured with the Performance-Oriented Mobility Assessment (POMA); sarcopenia, measured with the Strength, Assistance with Walking, Rise from a Chair, Climb Stairs, and Falls Questionnaire (SARC-F); functional independence, measured with the Barthel Index; fear of falling, measured with the Short Falls Efficacy Scale-International (Short FES-I); and the number of falls occurring during the study period.
Assessments were conducted at baseline, immediately after the intervention (8 weeks), and at follow-up (20 weeks). The study evaluated both the immediate effects of the intervention and the persistence of outcomes after cessation.
This study was retrospectively registered following completion of data collection.
- Conditions
- Balance Impairment, Sarcopenia in Elderly, Frailty at Older Adults, Functional Decline, Fall Risk
- Being tested
- Multicomponent Exercise Program (BASE), Usual Care
- Keywords
- multicomponent exercise, frailty, older adults, nursing homes, balance training, functional performance, fall prevention, physical therapy, institutionalizad elderly
- 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 (BASE)Behavioural
A supervised multicomponent exercise program including strength and balance training, performed twice weekly for 8 weeks. Each session lasted 30-40 minutes and included warm-up, strength exercises, and progressively adapted balance tasks based on individual capacity.
Usual CareOther
Also called Standard care
Participants continued their usual care and routine physical activities provided by the nursing homes without additional structured intervention.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Exercise Program (BASE) | Experimental | Participants engaged in a supervised multicomponent exercise program including strength and balance training, performed twice weekly for 8 weeks. Receives: Behavioral: Multicomponent Exercise Program (BASE) |
| Usual Care | Other | Participants continued their usual care and routine activities provided by their nursing homes. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty assessed by the Short Physical Performance Battery (SPPB)
Frailty was measured using the Short Physical Performance Battery (SPPB), which includes assessments of balance, gait speed, and chair rise performance. Total scores range from 0 to 12, with higher scores indicating better physical performance.
Measured: Baseline to 8 weeks
Secondary outcomes (5)
Balance assessed by the Performance-Oriented Mobility Assessment (POMA)
Balance was measured using the Performance-Oriented Mobility Assessment (POMA), which evaluates static and dynamic balance as well as gait performance. Total scores range from 0 to 28, with higher scores indicating better balance and mobility.
Measured: Baseline, 8 weeks, and 20 weeks
Sarcopenia assessed by SARC-F
Sarcopenia was measured using the Strength, Assistance with Walking, Rise from a Chair, Climb Stairs, and Falls Questionnaire (SARC-F), a self-reported screening tool for sarcopenia risk. Total scores range from 0 to 10, with higher scores indicating a greater risk of sarcopenia.
Measured: Baseline, 8 weeks, and 20 weeks
Functional independence assessed by the Barthel Index
Functional independence was measured using the Barthel Index, which assesses the ability to perform activities of daily living, including feeding, bathing, dressing, toileting, mobility, and stair climbing. Total scores range from 0 to 100, with higher scores indicating greater functional independence.
Measured: Baseline, 8 weeks, and 20 weeks
Fear of falling assessed by Short FES-I
Fear of falling was measured using the Short Falls Efficacy Scale-International (Short FES-I), which assesses concerns about falling during everyday activities. Total scores range from 7 to 28, with higher scores indicating greater fear of falling.
Measured: Baseline, 8 weeks, and 20 weeks
Number of falls
Falls were measured as the total number of falls recorded during the study period using incident reports from the participating nursing homes. Higher values indicate a greater frequency of falls.
Measured: Throughout the 20-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start30 Nov 2021
- Primary completion31 Jan 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance ImpairmentStudies 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
- Parallel groups
- Model description
- Participants were allocated by residential center to either an intervention group or a control group in a non-randomized parallel design. The intervention group received a multicomponent exercise program, while the control group continued usual care.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escoles Universitaries Gimbernat
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jadrana Sore, Escoles Universitaries Gimbernat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686146
- Sponsor's protocol ID
- CEEAH-UAB-5654
- Acronym
- BASE-Frail
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multicomponent Exercise Program on Frailty in Institutionalized Older Adults: A Multicenter Controlled Study
- ClinicalTrials.gov ID
- NCT07686146
- Acronym / sponsor ID
- BASE-Frail / CEEAH-UAB-5654
- Conditions
- Balance Impairment, Sarcopenia in Elderly, Frailty at Older Adults, Functional Decline, Fall Risk
- Keywords
- multicomponent exercise, frailty, older adults, nursing homes, balance training, functional performance, fall prevention, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Escoles Universitaries GimbernatUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 Jul 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.
Frailty is common among older adults living in nursing homes and increases the risk of falls, disability, and loss of independence. However, there is limited evidence on practical and feasible exercise programs adapted to this population.
This study evaluated the effects of a multicomponent exercise program combining strength and balance training in residents aged 65 years and older. Participants were assigned to either an intervention group, which performed supervised exercise sessions twice a week for 8 weeks, or a control group, which continued their usual activities.
The main outcome was frailty, measured using the Short Physical Performance Battery. Other outcomes included balance, functional independence, sarcopenia, fear of falling, and number of falls.
This study was retrospectively registered.
Detailed description
Frailty is a multidimensional clinical condition highly prevalent among older adults living in institutional settings and is associated with increased risk of falls, disability, hospitalization, and mortality. Despite growing evidence supporting physical exercise interventions, there is still a need for structured, feasible, and clinically applicable programs specifically designed for nursing home residents.
This study aimed to evaluate the effects of a multicomponent exercise program on frailty and related outcomes in institutionalized older adults. A multicenter, controlled, non-randomized design was used, including participants recruited from eight nursing homes.
Participants aged 65 years and older were allocated by residential center to either an intervention group or a control group. The intervention group participated in the Balance and Strength Exercises (BASE) program, consisting of supervised sessions performed twice weekly for 8 weeks. Each session included a combination of strength and balance exercises with progressive levels adapted to individual capacity. The control group continued their usual care and routine activities.
The primary outcome was frailty, assessed using the Short Physical Performance Battery (SPPB). Secondary outcomes included balance, measured with the Performance-Oriented Mobility Assessment (POMA); sarcopenia, measured with the Strength, Assistance with Walking, Rise from a Chair, Climb Stairs, and Falls Questionnaire (SARC-F); functional independence, measured with the Barthel Index; fear of falling, measured with the Short Falls Efficacy Scale-International (Short FES-I); and the number of falls occurring during the study period.
Assessments were conducted at baseline, immediately after the intervention (8 weeks), and at follow-up (20 weeks). The study evaluated both the immediate effects of the intervention and the persistence of outcomes after cessation.
This study was retrospectively registered following completion of data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were allocated by residential center to either an intervention group or a control group in a non-randomized parallel design. The intervention group received a multicomponent exercise program, while the control group continued usual care.
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Exercise Program (BASE) | Experimental | Behavioral: Multicomponent Exercise Program (BASE)Participants engaged in a supervised multicomponent exercise program including strength and balance training, performed twice weekly for 8 weeks. |
| Usual Care | Other | Other: Usual CareParticipants continued their usual care and routine activities provided by their nursing homes. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged 65 years or older
- Living in a nursing home
- Ability to walk at least 10 meters (with or without assistive devices)
- Mini-Mental State Examination (MMSE) score ≥19
Key exclusion criteria (5 listed)
- Neurodegenerative diseases
- Advanced dementia
- Parkinson's disease
- Hemodynamic instability
- Lower limb fractures under rehabilitation within the past year
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 (BASE)A supervised multicomponent exercise program including strength and balance training, performed twice weekly for 8 weeks. Each session lasted 30-40 minutes and included warm-up, strength exercises, and progressively adapted balance tasks based on individual capacity. | Behavioural | Multicomponent Exercise Program (BASE) |
| Usual CareAlso: Standard careParticipants continued their usual care and routine physical activities provided by the nursing homes without additional structured intervention. | Other | Usual Care |
Primary outcome
Frailty assessed by the Short Physical Performance Battery (SPPB)
Time frame: Baseline to 8 weeks
Frailty was measured using the Short Physical Performance Battery (SPPB), which includes assessments of balance, gait speed, and chair rise performance. Total scores range from 0 to 12, with higher scores indicating better physical performance.
5 secondary outcomes
Balance assessed by the Performance-Oriented Mobility Assessment (POMA)
Time frame: Baseline, 8 weeks, and 20 weeks
Sarcopenia assessed by SARC-F
Time frame: Baseline, 8 weeks, and 20 weeks
Functional independence assessed by the Barthel Index
Time frame: Baseline, 8 weeks, and 20 weeks
Fear of falling assessed by Short FES-I
Time frame: Baseline, 8 weeks, and 20 weeks
Number of falls
Time frame: Throughout the 20-week study period
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 7 Jul 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Exercise Program (BASE) in people with Balance Impairment and Sarcopenia in Elderly, run by Escoles Universitaries Gimbernat 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 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: finished, as of the sponsor's last update on 7 Jul 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?
Frailty assessed by the Short Physical Performance Battery (SPPB) (time frame: Baseline to 8 weeks). 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 7 Jul 2026.