Recovery From Disability After Geriatric-home Rehabilitation Versus Standard of Care: Pilot Study

NCT06404138 | Completed

• 2 other identifiers: S65872KCE22-1383
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Disability Physical

Keywords

Disability; Geriatric; Rehabilitation

Outcome Measures

Primary Outcomes (6)

• Feasibility of recruitment - screening

  The number of potential participants screened/not screened for inclusion.

  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).

  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.

  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.

  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.

  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.

  1 year

Secondary Outcomes (6)

• The profiles of study participants

  1 year

• Time spent on study procedures and assessments

  1 year

• The study burden for participants (older persons)

  6 weeks

• The study burden for healthcare professionals

  1 year

• Physical therapists' experiences with the training protocol

  1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

Receives 18 physiotherapy sessions at home over 6 weeks according to the Geriatric Activation program Pellenberg (GAPP, see intervention)

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.

Other: Standard of care

Interventions

The Geriatric Activation Program (GAPP) Home version OTHER

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.

Intervention group

Standard of care OTHER

Standard of care, without any restrictions.

Control group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• CHU UCL Namur: collaborator

Study Sites (2)

CHU UCL Namur

Godinne, 5530, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 40544287 DERIVED

Related Links

• Trial description on funder web page

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Theo van Achterberg, MSc, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study nurse, who assesses the outcomes during home visits (baseline, after six weeks, after one year) will be blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomized 1:1 in one of the two intervention groups

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: May 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: July 2, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)