FallsGAIT2CARENCT06936865
Effectiveness of a Home-Based Multicomponent Exercise Program With Digital Support in Community-Dwelling Older Adults With Falls
A study testing VIVIFIL App Program and Hospital-Based Multicomponent Exercise in people with Falls and Frailty Syndrome, run by Spanish National Research Council at 1 site in Spain.
Trial summary
This study evaluates the effectiveness of an 8-week multicomponent exercise program conducted at home with digital support through the VIVIFIL mobile application, compared to a traditional in-person hospital-based exercise program, in community-dwelling older adults with a history of falls. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Falls, Frailty Syndrome, Gait Disorders
- What is being tested?
- VIVIFIL App Program and Hospital-Based Multicomponent Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jul 2023to 28 Feb 2025
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 70 years or older
- Attending a specialized falls clinic at one of the participating hospitals
- Able to ambulate independently or with the aid of one or two canes
- At least one of the following:
- A fall with consequences requiring medical attention in the past year
- Two or more falls in the past 12 months
- Self-reported gait or balance disturbance
- Self-reported fear of falling
Who cannot join
- Terminal illness with a life expectancy of less than 6 months
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Home-Based Multicomponent Exercise Program With Digital Support in Community-Dwelling Older Adults With Falls: A Multicenter Quasiexperimental Trial (GAITCARE Study)
This study evaluates the effectiveness of an 8-week multicomponent exercise program conducted at home with digital support through the VIVIFIL mobile application, compared to a traditional in-person hospital-based exercise program, in community-dwelling older adults with a history of falls. The GAIT2CARE study is a multicenter, non-randomized, quasiexperimental clinical trial conducted in three Spanish public hospitals.
Participants aged 70 years or older were assigned to one of two intervention groups depending on the hospital: (1) home-based exercise using the VIVIFIL App with remote monitoring by a healthcare professional, or (2) conventional in-person multicomponent exercise supervised at the hospital. Both interventions included aerobic, strength, balance, and flexibility training.
The study aims to assess improvements in physical performance (SPPB, TUG, gait speed), frailty status, and fall incidence. Baseline and post-intervention assessments were conducted over an 8-week period. The hypothesis is that the home-based digital program is as effective as in-person exercise in improving functional outcomes and preventing falls in older adults.
Read the detailed description
The GAIT2CARE study is a multicenter, non-randomized, quasiexperimental clinical trial designed to evaluate the effectiveness of a home-based, multicomponent exercise intervention supported by a mobile application (VIVIFIL App) compared to a conventional in-person hospital-based program in community-dwelling older adults with a history of falls.
The study was conducted in three public university hospitals in Spain: Hospital Universitario Infanta Leonor, Hospital Universitario de Getafe, and Hospital Universitario de Albacete. A total of 127 participants aged 70 years or older were recruited from specialized fall clinics between December 2023 and March 2024. Eligibility criteria included a history of falls, ability to walk independently or with one or two canes, and absence of terminal illness. Participants were assigned to either the intervention or control group based on their hospital site, as per standard clinical practice.
The intervention group used the VIVIFIL App, a tool specifically designed for older adults to guide daily exercise at home. The App includes tailored training programs based on functional reserve (measured by SPPB), progressive difficulty levels, and real-time communication with healthcare professionals. Participants who lacked smartphones were provided with one and received training on how to use the App.
The control group attended conventional multicomponent exercise sessions (45-60 minutes, 2-4 times per week) at a geriatric day hospital under professional supervision. Both programs included strength, aerobic, flexibility, and balance training.
Primary outcomes included changes in physical performance (SPPB, Timed Up and Go [TUG], 4-meter gait speed), frailty status, and incidence of falls. Assessments were conducted at baseline and after 8 weeks. The study also included an analysis of factors influencing response to the intervention, such as baseline frailty, cognitive status, and adherence.
- Conditions
- Falls, Frailty Syndrome, Gait Disorders, Mobility Limitation, Aging, Sedentary Behaviors
- Being tested
- VIVIFIL App Program, Hospital-Based Multicomponent Exercise
- Keywords
- Multicomponent Exercise, Digital Health, Home-based Intervention, Older Adults, Physical Performance, VIVIFIL App, Fall Prevention, Remote Monitoring, Geriatric Rehabilitation
- Medical subject headings
- Frailty, Mobility Limitation, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVIFIL App ProgramBehavioural
A digitally supported multicomponent exercise program delivered through the VIVIFIL mobile application. Participants followed a daily home-based routine including strength, balance, flexibility, and aerobic exercises, adapted to their functional reserve. The app provided video instructions, progression tracking, and a chat for remote communication with healthcare professionals.
Hospital-Based Multicomponent ExerciseBehavioural
A supervised multicomponent exercise program delivered at a geriatric day hospital by trained professionals. Sessions lasted 45-60 minutes, 2-4 times per week for 8 weeks. Exercises included strength training, balance, flexibility, and aerobic components, adjusted to the participant's functional status.
| Study group | Role | What they receive |
|---|---|---|
| Home-based Exercise with Digital Support (ViviFil App) | Experimental | Participants in this arm followed a personalized multicomponent exercise program at home using the VIVIFIL mobile application. The program included strength, balance, flexibility, and aerobic exercises adapted to each participant's functional capacity (based on SPPB score). The VIVIFIL App was installed on participants' smartphones or provided devices and included daily video-guided sessions, automatic progression, and a chat function for communication with healthcare professionals who provided remote monitoring. Receives: Behavioral: VIVIFIL App Program |
| In-person Supervised Exercise at Geriatric Day Hospital | Active comparator | Participants in this arm attended supervised multicomponent exercise sessions at the Geriatric Day Hospital, 2-4 times per week for 8 weeks. Each session lasted 45-60 minutes and was delivered by trained professionals. Exercises included strength training, balance exercises, flexibility, and aerobic conditioning. Programs were tailored based on the participant's initial functional assessment. Receives: Behavioral: Hospital-Based Multicomponent Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Physical Performance Battery (SPPB) Score
The SPPB is a standardized assessment tool that includes gait speed, chair stand, and balance tests. Scores range from 0 to 12, with higher scores indicating better physical performance. The primary outcome is the change in total SPPB score from baseline to 8 weeks.
Measured: Baseline and 8 weeks
Secondary outcomes (1)
Change in 4-Meter Gait Speed
Gait speed (m/s) is measured over a 4-meter walk. The best of three trials is recorded. Higher speed reflects better functional capacity.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start27 Jul 2023
- Primary completion27 May 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study follows a parallel, non-randomized interventional model. Participants were assigned to one of two arms based on the hospital where they received care, following standard clinical practice. No crossover occurred between groups. Each arm received a multicomponent exercise intervention with similar structure and objectives, delivered either in-person or at home with digital support. The primary comparison focuses on functional outcomes and fall incidence between the two settings.
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish National Research Council
- Sponsor type
- Other government
- Collaborators
- Hospital Universitario Infanta Leonor, Servicio de Salud de Castilla La Mancha, Albacete, Spain, Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, Antonio R. Jiménez Ruiz, Spanish National Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936865
- Sponsor's protocol ID
- GAIT2CARE-2023
- Other IDs
- CEIm approval code 2023-071
- Acronym
- GAIT2CARE
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) underlying published results will be made available after study completion and publication. The data will be fully anonymized and shared upon reasonable request with qualified researchers for academic and non-commercial purposes. Requests must include a methodologically sound proposal and may require approval by an independent ethics committee. Data access will be provided through a secure platform or encrypted file transfer.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Home-Based Multicomponent Exercise Program With Digital Support in Community-Dwelling Older Adults With Falls: A Multicenter Quasiexperimental Trial (GAITCARE Study)
- ClinicalTrials.gov ID
- NCT06936865
- Acronym / sponsor ID
- GAIT2CARE / GAIT2CARE-2023
- Conditions
- Falls, Frailty Syndrome, Gait Disorders, Mobility Limitation, Aging, Sedentary Behaviors
- Keywords
- Multicomponent Exercise, Digital Health, Home-based Intervention, Older Adults, Physical Performance, VIVIFIL App, Fall Prevention, Remote Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Spanish National Research CouncilOther government
- Collaborators
- Hospital Universitario Infanta Leonor, Servicio de Salud de Castilla La Mancha, Albacete, Spain, Universidad Rey Juan Carlos
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 20 Apr 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.
This study evaluates the effectiveness of an 8-week multicomponent exercise program conducted at home with digital support through the VIVIFIL mobile application, compared to a traditional in-person hospital-based exercise program, in community-dwelling older adults with a history of falls. The GAIT2CARE study is a multicenter, non-randomized, quasiexperimental clinical trial conducted in three Spanish public hospitals.
Participants aged 70 years or older were assigned to one of two intervention groups depending on the hospital: (1) home-based exercise using the VIVIFIL App with remote monitoring by a healthcare professional, or (2) conventional in-person multicomponent exercise supervised at the hospital. Both interventions included aerobic, strength, balance, and flexibility training.
The study aims to assess improvements in physical performance (SPPB, TUG, gait speed), frailty status, and fall incidence. Baseline and post-intervention assessments were conducted over an 8-week period. The hypothesis is that the home-based digital program is as effective as in-person exercise in improving functional outcomes and preventing falls in older adults.
Detailed description
The GAIT2CARE study is a multicenter, non-randomized, quasiexperimental clinical trial designed to evaluate the effectiveness of a home-based, multicomponent exercise intervention supported by a mobile application (VIVIFIL App) compared to a conventional in-person hospital-based program in community-dwelling older adults with a history of falls.
The study was conducted in three public university hospitals in Spain: Hospital Universitario Infanta Leonor, Hospital Universitario de Getafe, and Hospital Universitario de Albacete. A total of 127 participants aged 70 years or older were recruited from specialized fall clinics between December 2023 and March 2024. Eligibility criteria included a history of falls, ability to walk independently or with one or two canes, and absence of terminal illness. Participants were assigned to either the intervention or control group based on their hospital site, as per standard clinical practice.
The intervention group used the VIVIFIL App, a tool specifically designed for older adults to guide daily exercise at home. The App includes tailored training programs based on functional reserve (measured by SPPB), progressive difficulty levels, and real-time communication with healthcare professionals. Participants who lacked smartphones were provided with one and received training on how to use the App.
The control group attended conventional multicomponent exercise sessions (45-60 minutes, 2-4 times per week) at a geriatric day hospital under professional supervision. Both programs included strength, aerobic, flexibility, and balance training.
Primary outcomes included changes in physical performance (SPPB, Timed Up and Go [TUG], 4-meter gait speed), frailty status, and incidence of falls. Assessments were conducted at baseline and after 8 weeks. The study also included an analysis of factors influencing response to the intervention, such as baseline frailty, cognitive status, and adherence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study follows a parallel, non-randomized interventional model. Participants were assigned to one of two arms based on the hospital where they received care, following standard clinical practice. No crossover occurred between groups. Each arm received a multicomponent exercise intervention with similar structure and objectives, delivered either in-person or at home with digital support. The primary comparison focuses on functional outcomes and fall incidence between the two settings.
| Arm | Type | Receives |
|---|---|---|
| Home-based Exercise with Digital Support (ViviFil App) | Experimental | Behavioral: VIVIFIL App ProgramParticipants in this arm followed a personalized multicomponent exercise program at home using the VIVIFIL mobile application. The program included strength, balance, flexibility, and aerobic exercises adapted to each participant's functional capacity (based on SPPB score). The VIVIFIL App was installed on participants' smartphones or provided devices and included daily video-guided sessions, automatic progression, and a chat function for communication with healthcare professionals who provided remote monitoring. |
| In-person Supervised Exercise at Geriatric Day Hospital | Active comparator | Behavioral: Hospital-Based Multicomponent ExerciseParticipants in this arm attended supervised multicomponent exercise sessions at the Geriatric Day Hospital, 2-4 times per week for 8 weeks. Each session lasted 45-60 minutes and was delivered by trained professionals. Exercises included strength training, balance exercises, flexibility, and aerobic conditioning. Programs were tailored based on the participant's initial functional assessment. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Age 70 years or older
- Attending a specialized falls clinic at one of the participating hospitals
- Able to ambulate independently or with the aid of one or two canes
- At least one of the following:
Key exclusion criteria (2 listed)
- Terminal illness with a life expectancy of less than 6 months
- Refusal or inability to provide informed consent
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 |
|---|---|---|
| VIVIFIL App ProgramA digitally supported multicomponent exercise program delivered through the VIVIFIL mobile application. Participants followed a daily home-based routine including strength, balance, flexibility, and aerobic exercises, adapted to their functional reserve. The app provided video instructions, progression tracking, and a chat for remote communication with healthcare professionals. | Behavioural | Home-based Exercise with Digital Support (ViviFil App) |
| Hospital-Based Multicomponent ExerciseA supervised multicomponent exercise program delivered at a geriatric day hospital by trained professionals. Sessions lasted 45-60 minutes, 2-4 times per week for 8 weeks. Exercises included strength training, balance, flexibility, and aerobic components, adjusted to the participant's functional status. | Behavioural | In-person Supervised Exercise at Geriatric Day Hospital |
Primary outcome
Change in Short Physical Performance Battery (SPPB) Score
Time frame: Baseline and 8 weeks
The SPPB is a standardized assessment tool that includes gait speed, chair stand, and balance tests. Scores range from 0 to 12, with higher scores indicating better physical performance. The primary outcome is the change in total SPPB score from baseline to 8 weeks.
1 secondary outcome
Change in 4-Meter Gait Speed
Time frame: Baseline and 8 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 20 Apr 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) underlying published results will be made available after study completion and publication. The data will be fully anonymized and shared upon reasonable request with qualified researchers for academic and non-commercial purposes. Requests must include a methodologically sound proposal and may require approval by an independent ethics committee. Data access will be provided through a secure platform or encrypted file transfer.
Related trials for Falls
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
Active, not recruiting
COMPARATIVE EFFECTS OF SENSORY REWEIGHTING AND PROPRIOCEPTIVE FACILITATION TRAINING ON BALANCE AND FALL RISK IN DIABETIC PERIPHERAL NEUROPATHY
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Exercise and Fall Prevention
Osteopenia, Osteoporosis
Not yet recruiting
Beren Vibration Insole in Stroke Rehabilitation
Stroke
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 VIVIFIL App Program and Hospital-Based Multicomponent Exercise in people with Falls and Frailty Syndrome, run by Spanish National Research Council 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 8 inclusion and 2 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 20 Apr 2025. 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 Short Physical Performance Battery (SPPB) Score (time frame: Baseline and 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 20 Apr 2025.