Disability PhysicalRECOVER@HOMENCT06404138
Recovery From Disability After Geriatric-home Rehabilitation Versus Standard of Care: Pilot Study
A study testing The Geriatric Activation Program (GAPP) Home version in people with Disability Physical, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial summary
At discharge after a hospitalization, many older people are not as able as before their hospital stay and have difficulty performing their daily activities at home. For example, washing and dressing themselves, housework or shopping are often more difficult after discharge from hospital. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Disability Physical
- What is being tested?
- The Geriatric Activation Program (GAPP) Home version
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 May 2024to 2 Jul 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 75 years of age or older;
- disability (i.e., dependent in one or more activities of daily living) at hospital discharge;
- rehabilitation potential;
- capable of giving informed consent, and also giving their consent;
Who cannot join
- discharged to a nursing home or rehabilitation centre;
- receiving palliative care;
- enrolled in a specialised rehabilitation programme, e.g. cardiac rehabilitation, stroke rehabilitation, respiratory rehabilitation for COPD, and oncology rehabilitation;
- in active follow-up with a physical therapist, and for whom participation in the intervention would be too demanding or would compromise the integrity of the therapy and its anticipated outcomes.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Recovery From Disability After Geriatric-home Rehabilitation Versus Standard of Care: Pilot Study for a Randomised Multicentre Parallel Group Pragmatic Trial in Older Persons With Disability at Hospital Discharge.
At discharge after a hospitalization, many older people are not as able as before their hospital stay and have difficulty performing their daily activities at home. For example, washing and dressing themselves, housework or shopping are often more difficult after discharge from hospital. However, most older people do not receive any support in regaining their physical status and self-reliance. As a result, they often need permanent help from informal or professional caregivers. Their quality of life is also impacted and they have an increased risk of new hospital admissions.
Rehabilitation centers and hospital rehabilitation wards help the elderly to regain their daily functioning, but the number of places is very limited. This means that support for home rehabilitation is necessary for the vast majority of older people (almost 82,000 people per year). However, most of the time there is no support for home rehabilitation and the effect of such home rehabilitation programs has been little studied. Although studies show that home rehabilitation can improve physical functioning, the effect on impairments in daily activities and the quality of life of older people are not clear.
Read more
In a future multicenter RCT, the investigators want to study whether training and guidance by a physiotherapist contributes to the recovery of older people after discharge from hospital.
Patients will either receive standard care after hospitalization discharge, or intensive guidance from a physiotherapist. The patients guided by the physiotherapist are trained and supervised three times a week, for six weeks, to improve their muscle strength, balance, walking and mobility. The aim of the intensive home rehabilitation program is that the individual benefits from it in the longer term. Therefore, whether individuals who received the program are less limited in their daily functioning than those who did not receive the intensive rehabilitation program is checked after six months. In addition, the quality of life, physical functioning and healthcare costs for these two groups are also compared.
To ensure that the study is feasible, a small pilot study will first be performed. Here, the aim is to assess the feasibility of recruitment (screening and retaining participants, reasons for refusal and participant profiles), study procedures and intervention. This includes time registration by the study team and physiotherapists, assessment of study burden and experiences with the execution of the protocol. The findings of this pilot study will help deciding about progressing to a future definitive RCT.
- Conditions
- Disability Physical
- Being tested
- The Geriatric Activation Program (GAPP) Home version, Standard of care
- Keywords
- Disability, Geriatric, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Geriatric Activation Program (GAPP) Home versionOther
The rehabilitation at home intervention consists of three 45 minutes session per week (total of 18 sessions) with a different focus for each session. The therapy is goal-oriented and includes functional exercises in the home where possible (e.g. transfers such as getting out of bed, walking to the toilet etc.). There are three sessions per week: 1 for training strength, 1 for training balance and 1 for speed, coordination and endurance. Each session will start with gait rehabilitation as a warming-up.
For each session, a set of exercises with varying levels of difficulty is available. As rehabilitation needs are diverse, the therapist is expected to choose the most appropriate exercise and the difficulty level of the exercise for the individual older person. This also includes scaling the exercises to the individual progression of the older person.
Standard of careOther
Standard of care, without any restrictions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Receives 18 physiotherapy sessions at home over 6 weeks according to the Geriatric Activation program Pellenberg (GAPP, see intervention) Receives: Other: The Geriatric Activation Program (GAPP) Home version |
| Control group | Other | Older persons in the control group receive the standard of care, without any restrictions. This implies that some of the older persons in the control group could receive physical therapy, but the standard of care implies that although geriatricians regularly prescribe physical therapy the therapy is actually not started in most cases. Therefore, physical therapy will not often be delivered in the control group, and if it is delivered it will be less structured and at lower intensity and/or frequency. Moreover, physical therapy delivered to participants in the control group will not be supported by a targeted rehabilitation plan and a specific training for the therapists. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment - screening
The number of potential participants screened/not screened for inclusion.
Measured: 1 year
Feasibility of recruitment - retainment
The number of (potential) participants recruited/not recruited, randomised and retained (frequency and proportion of participants that are randomized and completed 6w follow up).
Measured: 1 year
Feasibility of recruitment - reasons for non-participation
Potential participants' reasons for refusing to participate (qualitative), expressed in frequency per reason for declining participation.
Measured: 1 year
Feasibility of study procedures, assessments and data collection
Assessment will focus on the timeliness and practicality of the randomisation, assessment and the data collection in the participants' home, processing and managing the data and study administration. This endpoint is assessed through interviewing study staff about their experiences.
Measured: 1 year
Study participants' experience with the intervention
Semi-structured interviews with participants, assessing how the intervention did or did not meet their needs, intervention elements they did or did not appreciate, their perceived adherence to the therapy sessions, the level of difficulty of intervention elements in relation to their level of disability, the support from their therapist, the perceived benefit or lack thereof, their reasons for engaging or discontinuing the intervention, and reasons for (not) recommending the intervention to others in the same position.
Measured: 1 year
Physical therapists' experience with the intervention
Interviews with physical therapists, addressing feasibility with a view to alternative elements of the intervention, the target group, the setting and their professional capabilities and limitations. Questions will also explore their experience with the adherence of the participants, and their perceptions regarding factors that influenced this.
Measured: 1 year
Secondary outcomes (6)
The profiles of study participants
Demographic information
Measured: 1 year
Time spent on study procedures and assessments
The study nurses and medical doctors participating in the study will log the time they spend on the study in an electronic logbook. This will be done for patient 5 to 12 at each site. Time will be recorded in minutes per day, and will be stratified for screening, informed consent, randomisation, baseline visit, visit at 6 weeks follow-up, administration, and other. Data will be gathered up to six weeks when the intervention protocol is completed and follow-up data at six weeks are gathered. The endpoint will be expressed as the median time to complete the study procedures per participant.
Measured: 1 year
The study burden for participants (older persons)
Audio recorded interviews using open-ended questions will focus on understanding how persons experience study participation and which aspects of the study might be perceived as hindrances or barriers in relation to their daily lives.Second, a modified version of the Perceived Research Burden Assessment instrument (5-point Likert scales) is used to quantify the study burden for individual participants.
Measured: 6 weeks
The study burden for healthcare professionals
Structured interviews, focusing on understanding how they experienced screening for eligibility and how this could be disruptive for their daily practice.
Measured: 1 year
Physical therapists' experiences with the training protocol
Physical therapists' experiences with the training needed to deliver the rehabilitation protocol will be assessed in a structured interview. Interview questions will focus on the format, the delivery, the content, and the duration of the training. Participants will also be asked to suggest changes or improvements. The interview is performed online and after completion of the training, and is audio recorded.
Measured: 1 year
Blinding of outcome assessors
Structured interview addressing for which participants the study nurses feel they know, suspect or do not know to which group a person was randomized, and -if relevant- how they found out. Nurses' ideas of group allocation will be checked against the actual group allocation. This information will be used to construct a Blinding Index. This endpoint will be expressed as the frequency and proportion of participants where blinding was not achieved.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 May 2024
- Primary completion31 Jan 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized 1:1 in one of the two intervention groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire UCLouvain Namur
- Responsible party
- Sponsor
- Investigators
- Theo van Achterberg, MSc, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404138
- Sponsor's protocol ID
- S65872
- Other IDs
- KCE22-1383
- Acronym
- RECOVER@HOME
- Status last verified
- Oct 2025
- First submitted
- 3 May 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared upon publication of the primary endpoint of the full trial, which will have a separate registration on clinicaltrial.gov.
Publications
Van Grootven B, van Dijk M, Islam F, Coucke B, Fieuws S, Van Pottelbergh G, Flamaing J, Van Den Noortgate N, Velghe A, De Cock AM, Gillain S, Meeuwissen J, Bautmans I, Beckwee D, de Saint-Hubert M, van Uffelen J, Schoevaerdts D, Tournoy J, van Achterberg T. Recovery from disability after geriatric-home rehabilitation versus standard of care: protocol for a pilot study in older persons with disability at hospital discharge. Pilot Feasibility Stud. 2025 Jun 21;11(1):87. doi: 10.1186/s40814-025-01668-8.
PubMed 40544287
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery From Disability After Geriatric-home Rehabilitation Versus Standard of Care: Pilot Study for a Randomised Multicentre Parallel Group Pragmatic Trial in Older Persons With Disability at Hospital Discharge.
- ClinicalTrials.gov ID
- NCT06404138
- Acronym / sponsor ID
- RECOVER@HOME / S65872
- Conditions
- Disability Physical
- Keywords
- Disability, Geriatric, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire UCLouvain Namur
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 8 May 2024 (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.
At discharge after a hospitalization, many older people are not as able as before their hospital stay and have difficulty performing their daily activities at home. For example, washing and dressing themselves, housework or shopping are often more difficult after discharge from hospital. However, most older people do not receive any support in regaining their physical status and self-reliance. As a result, they often need permanent help from informal or professional caregivers. Their quality of life is also impacted and they have an increased risk of new hospital admissions.
Rehabilitation centers and hospital rehabilitation wards help the elderly to regain their daily functioning, but the number of places is very limited. This means that support for home rehabilitation is necessary for the vast majority of older people (almost 82,000 people per year). However, most of the time there is no support for home rehabilitation and the effect of such home rehabilitation programs has been little studied. Although studies show that home rehabilitation can improve physical functioning, the effect on impairments in daily activities and the quality of life of older people are not clear.
In a future multicenter RCT, the investigators want to study whether training and guidance by a physiotherapist contributes to the recovery of older people after discharge from hospital.
Patients will either receive standard care after hospitalization discharge, or intensive guidance from a physiotherapist. The patients guided by the physiotherapist are trained and supervised three times a week, for six weeks, to improve their muscle strength, balance, walking and mobility. The aim of the intensive home rehabilitation program is that the individual benefits from it in the longer term. Therefore, whether individuals who received the program are less limited in their daily functioning than those who did not receive the intensive rehabilitation program is checked after six months. In addition, the quality of life, physical functioning and healthcare costs for these two groups are also compared.
To ensure that the study is feasible, a small pilot study will first be performed. Here, the aim is to assess the feasibility of recruitment (screening and retaining participants, reasons for refusal and participant profiles), study procedures and intervention. This includes time registration by the study team and physiotherapists, assessment of study burden and experiences with the execution of the protocol. The findings of this pilot study will help deciding about progressing to a future definitive RCT.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomized 1:1 in one of the two intervention groups
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: The Geriatric Activation Program (GAPP) Home versionReceives 18 physiotherapy sessions at home over 6 weeks according to the Geriatric Activation program Pellenberg (GAPP, see intervention) |
| Control group | Other | Other: Standard of careOlder persons in the control group receive the standard of care, without any restrictions. This implies that some of the older persons in the control group could receive physical therapy, but the standard of care implies that although geriatricians regularly prescribe physical therapy the therapy is actually not started in most cases. Therefore, physical therapy will not often be delivered in the control group, and if it is delivered it will be less structured and at lower intensity and/or frequency. Moreover, physical therapy delivered to participants in the control group will not be supported by a targeted rehabilitation plan and a specific training for the therapists. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 75 years of age or older;
- disability (i.e., dependent in one or more activities of daily living) at hospital discharge;
- rehabilitation potential;
- capable of giving informed consent, and also giving their consent;
Key exclusion criteria (4 listed)
- discharged to a nursing home or rehabilitation centre;
- receiving palliative care;
- enrolled in a specialised rehabilitation programme, e.g. cardiac rehabilitation, stroke rehabilitation, respiratory rehabilitation for COPD, and oncology rehabilitation;
- in active follow-up with a physical therapist, and for whom participation in the intervention would be too demanding or would compromise the integrity of the therapy and its anticipated outcomes.
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 |
|---|---|---|
| The Geriatric Activation Program (GAPP) Home versionThe rehabilitation at home intervention consists of three 45 minutes session per week (total of 18 sessions) with a different focus for each session. The therapy is goal-oriented and includes functional exercises in the home where possible (e.g. transfers such as getting out of bed, walking to the toilet etc.). There are three sessions per week: 1 for training strength, 1 for training balance and 1 for speed, coordination and endurance. Each session will start with gait rehabilitation as a warming-up. For each session, a set of exercises with varying levels of difficulty is available. As rehabilitation needs are diverse, the therapist is expected to choose the most appropriate exercise and the difficulty level of the exercise for the individual older person. This also includes scaling the exercises to the individual progression of the older person. | Other | Intervention group |
| Standard of careStandard of care, without any restrictions. | Other | Control group |
Primary outcome
Feasibility of recruitment - screening
Time frame: 1 year
The number of potential participants screened/not screened for inclusion.
Feasibility of recruitment - retainment
Time frame: 1 year
The number of (potential) participants recruited/not recruited, randomised and retained (frequency and proportion of participants that are randomized and completed 6w follow up).
Feasibility of recruitment - reasons for non-participation
Time frame: 1 year
Potential participants' reasons for refusing to participate (qualitative), expressed in frequency per reason for declining participation.
Feasibility of study procedures, assessments and data collection
Time frame: 1 year
Assessment will focus on the timeliness and practicality of the randomisation, assessment and the data collection in the participants' home, processing and managing the data and study administration. This endpoint is assessed through interviewing study staff about their experiences.
Study participants' experience with the intervention
Time frame: 1 year
Semi-structured interviews with participants, assessing how the intervention did or did not meet their needs, intervention elements they did or did not appreciate, their perceived adherence to the therapy sessions, the level of difficulty of intervention elements in relation to their level of disability, the support from their therapist, the perceived benefit or lack thereof, their reasons for engaging or discontinuing the intervention, and reasons for (not) recommending the intervention to others in the same position.
Physical therapists' experience with the intervention
Time frame: 1 year
Interviews with physical therapists, addressing feasibility with a view to alternative elements of the intervention, the target group, the setting and their professional capabilities and limitations. Questions will also explore their experience with the adherence of the participants, and their perceptions regarding factors that influenced this.
6 secondary outcomes
The profiles of study participants
Time frame: 1 year
Time spent on study procedures and assessments
Time frame: 1 year
The study burden for participants (older persons)
Time frame: 6 weeks
The study burden for healthcare professionals
Time frame: 1 year
Physical therapists' experiences with the training protocol
Time frame: 1 year
Blinding of outcome assessors
Time frame: 1 year
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 17 Nov 2025.
- Derived from this study: PubMed 40544287Van Grootven B, van Dijk M, Islam F, Coucke B, Fieuws S, Van Pottelbergh G, Flamaing J, Van Den Noortgate N, Velghe A, De Cock AM, Gillain S, Meeuwissen J, Bautmans I, Beckwee D, de Saint-Hubert M, van Uffelen J, Schoevaerdts D, Tournoy J, van Achterberg T. Recovery from disability after geriatric-home rehabilitation versus standard of care: protocol for a pilot study in older persons with disability at hospital discharge. Pilot Feasibility Stud. 2025 Jun 21;11(1):87. doi: 10.1186/s40814-025-01668-8.
- Trial description on funder web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will be shared upon publication of the primary endpoint of the full trial, which will have a separate registration on clinicaltrial.gov.
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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.
Theo van Achterberg, MSc, PhD principal investigator
KU Leuven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Geriatric Activation Program (GAPP) Home version in people with Disability Physical, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
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 4 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Feasibility of recruitment - screening (time frame: 1 year). The study lists 6 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 NCT06404138, which also lists 1 linked publication.
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 17 Nov 2025.