Recovery From Disability After Geriatric-home Rehabilitation Versus Standard of Care: Pilot Study (RECOVER@HOME)

November 14, 2025 updated by: Universitaire Ziekenhuizen KU Leuven

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.

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 Overview

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Godinne, Belgium, 5530
        • Chu Ucl Namur
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Receives 18 physiotherapy sessions at home over 6 weeks according to the Geriatric Activation program Pellenberg (GAPP, see intervention)

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.

Other: Control group
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.
Standard of care, without any restrictions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of recruitment - screening
Time Frame: 1 year
The number of potential participants screened/not screened for inclusion.
1 year
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).
1 year
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.
1 year
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.
1 year
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.
1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent on study procedures and assessments
Time Frame: 1 year
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.
1 year
The study burden for participants (older persons)
Time Frame: 6 weeks
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.
6 weeks
The study burden for healthcare professionals
Time Frame: 1 year
Structured interviews, focusing on understanding how they experienced screening for eligibility and how this could be disruptive for their daily practice.
1 year
Physical therapists' experiences with the training protocol
Time Frame: 1 year
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.
1 year
Blinding of outcome assessors
Time Frame: 1 year
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.
1 year
The profiles of study participants
Time Frame: 1 year
Demographic information
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Theo van Achterberg, MSc, PhD, KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

July 2, 2025

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • S65872
  • KCE22-1383 (Other Grant/Funding Number: KCE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be shared upon publication of the primary endpoint of the full trial, which will have a separate registration on clinicaltrial.gov.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Disability Physical

Clinical Trials on The Geriatric Activation Program (GAPP) Home version

Subscribe