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Clinical Trials/NCT05419284
NCT05419284
Completed
N/A

Feasibility of the Geriatric Activation Program Pellenberg With the Informal Caregiver as Exercise Partner of the Physiotherapist (GAPP+Care)

KU Leuven1 site in 1 country13 target enrollmentMarch 28, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hip Fractures
Sponsor
KU Leuven
Enrollment
13
Locations
1
Primary Endpoint
Proportion of eligible individuals and their willingness to participate in GAPP+Care
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This interventional study aims to see if involving caregivers as exercise partners with the physiotherapist throughout in-hospital geriatric rehabilitation and the first six weeks following discharge is feasible.

Caregivers will receive hands-on training from physiotherapists so that they can assist their family members with their exercises. The caregivers will provide 30-minute exercise sessions three times each week in addition to the standard physiotherapy.

The researchers want to know how many people are eligible for GAPP+CARE and how willing they are to participate. The researchers also want to know about the program's hindering and facilitating elements, as well as its fidelity and retention rate. Apart from that, the researchers want to examine if an effectiveness study and the used outcome measures are viable.

Detailed Description

To meet the WHO guideline for daily exercise during and after hospitalization, physiotherapists must find ways for geriatric patients to be active outside of therapy time. Geriatric patients require assistance or supervision to exercise safely, yet physiotherapists and nurses are short on time. Instead, by providing carers with tools and instruction, the researchers might turn them into exercise partners for the physiotherapist. The investigators designed an exercise program (GAPP+Care) customized to the caregiver's ability to exercise safely with their loved one, based on the ideas and exercises of our standard physiotherapy program, the Geriatric Activation Program Pellenberg (GAPP). Through semi-structured interviews, patients and their caregivers were involved in developing and validating GAPP+Care, including the exercise booklet. GAPP+Care consists of GAPP (the usual physiotherapy treatment) and three additional 30-minute exercise sessions with the caregiver each week (+Care). +Care will continue at home for the first six weeks after discharge, and GAPP will be replaced with physiotherapy performed by a private physiotherapist, as described at discharge (a prescription for home physiotherapy 3 times a week, for 60 sessions F-pathology or 18 sessions). The initial +Care session is with a ward physiotherapist who will show the caregiver how to utilize the GAPP+Care handbook and the exercises and teach them how to support the patient during the exercises. During hospitalization, one of the three weekly sessions will be led by a ward physiotherapist to reinforce the hands-on skills and knowledge. These physiotherapy-patient-caregiver sessions will consist of two home visits and four phone calls after the patient has been discharged. The goal of this exploratory study is to see if GAPP+Care is feasible. The researchers want to know how many people are eligible and how willing they are to participate. The researchers also want to assess the program's hindering and facilitating elements, as well as its fidelity and retention rate. Aside from that, the researchers want to evaluate if an effectiveness study and the used outcome measures are viable.

Registry
clinicaltrials.gov
Start Date
March 28, 2022
End Date
May 27, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
KU Leuven
Responsible Party
Principal Investigator
Principal Investigator

Margaretha van Dijk

Principal Investigator

KU Leuven

Eligibility Criteria

Inclusion Criteria

  • Patients from geriatric rehabilitation unit, with various pathologies
  • ≥ 70 years old
  • ≥ 10m of walking with walking aid and under supervision
  • Berg Balance Scale (BBS) \< 30/56
  • Medically stable as determined by the attending physician
  • Expecting at least 3 weeks of rehabilitation

Exclusion Criteria

  • No available caregiver
  • Unable to understand instructions
  • Caregivers:
  • Inclusion Criteria:
  • A person who is willing to support the patient in performing exercises at least 3 times a week for 30 minutes. An informal carer is defined as an unpaid member of a person's social network who helps the patient with activities of daily living.
  • Exclusion Criteria:
  • Physical unable to support the patient
  • Unable to understand instructions
  • Healthcare providers
  • Inclusion Criteria:

Outcomes

Primary Outcomes

Proportion of eligible individuals and their willingness to participate in GAPP+Care

Time Frame: 1 year

Number of available patients on the ward and number of eligible patients and caregivers and number of patients and caregivers who participate

Secondary Outcomes

  • Retention rate of participants(1 year)
  • Functional balance(3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at end of week 6 after discharge)
  • Walking speed(3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at the end of week 6 after discharge)
  • Feasibility, appropriateness, and the hindering and facilitating factors of GAPP+Care(patients and caregivers 2 times (at day of discharge and at the end of week 6 after discharge), healthcare providers 1 time (in the last 6 months of the study))
  • Fidelity to GAPP+Care(up to 12 weeks)
  • Number of falls during the +Care sessions(up to 12 weeks)
  • Hand squeeze force(3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at the end of week 6 after discharge)
  • Private physiotherapy after discharge(6 weeks)
  • Use of the activity monitor MOX, Maastricht Instruments(first week at baseline, first week after discharge (starting at day of discharge), and week 6 after discharge)
  • Quality of life patient and caregiver(3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at end of week 6 after discharge)

Study Sites (1)

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