Hip FracturesNCT05419284
Feasibility of the Geriatric Activation Program Pellenberg With Caregiver Involvement
A study testing GAPP+Care, +Care and Observation of GAPP+Care in people with Hip Fractures and Stroke, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures, Stroke, Frailty
- What is being tested?
- GAPP+Care, +Care and Observation of GAPP+Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Mar 2022to 27 May 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- 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.
- Someone who works on our ward, comes into contact with patients and may experience GAPP+CARE or its effects; nurse, physiotherapist, occupational therapist, social worker, doctor, logistical worker.
Who cannot join
- No available caregiver
- Unable to understand instructions
- Caregivers:
- Physical unable to support the patient
- Unable to understand instructions
- Healthcare providers
- -
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Universitaire Ziekenhuizen Leuven, campus Pellenberg
Pellenberg, 3212
About this study
Official title: Feasibility of the Geriatric Activation Program Pellenberg With the Informal Caregiver as Exercise Partner of the Physiotherapist (GAPP+Care)
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.
Read the 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.
- Conditions
- Hip Fractures, Stroke, Frailty
- Being tested
- GAPP+Care, +Care, Observation of GAPP+Care
- Keywords
- geriatric patients, geriatric rehabilitation, physiotherapy, caregiver involvement
- Medical subject headings
- Hip Fractures, Stroke, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAPP+CareOther
standard physiotherapy 45 minutes per day, 5 day a week (GAPP)
+ 3 extra exercise sessions led by a caregiver (+Care)
+CareOther
3 extra exercise moments led by a caregiver: one physiotherapist-caregiver-patient exercise session: the physiotherapist will educate and train the caregiver on the exercises and hands-on skills.
Two caregiver-patient exercise sessions
Observation of GAPP+CareOther
Healthcare workers in the geriatric rehabilitation ward will be interviewed on their opinions on GAPP+Care
| Study group | Role | What they receive |
|---|---|---|
| patient | Experimental | GAPP+Care Receives: Other: GAPP+Care |
| caregiver | Experimental | +Care Receives: Other: +Care |
| healthcare professional of the ward | Other | observation of GAPP+Care Receives: Other: Observation of GAPP+Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible individuals and their willingness to participate in GAPP+Care
Number of available patients on the ward and number of eligible patients and caregivers and number of patients and caregivers who participate
Measured: 1 year
Secondary outcomes (10)
Feasibility, appropriateness, and the hindering and facilitating factors of GAPP+Care
Semi-structured interviews with patients, caregivers and healthcare providers
Measured: 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
Number of exercise moments with physiotherapist; Noted in exercise diary Number of exercise moments with caregiver; Exercise Diary Number and kind of exercises with caregiver; Exercise Diary
Measured: up to 12 weeks
Retention rate of participants
Number of dropouts
Measured: 1 year
Number of falls during the +Care sessions
number of falls noted in the exercise diary or mentioned during the interviews
Measured: up to 12 weeks
Private physiotherapy after discharge
number of sessions per week
Measured: 6 weeks
Use of the activity monitor MOX, Maastricht Instruments
measuring daily activity in minutes/24hours (sedentary - standing - dynamic)
Measured: first week at baseline, first week after discharge (starting at day of discharge), and week 6 after discharge
Functional balance
Berg Balance Scale (BBS) 0-56, a higher score means a better outcome
Measured: 3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at end of week 6 after discharge
Hand squeeze force
Maximum handgrip with dominant hand, measured with the Martin Vigory dynamometer, in kPa
Measured: 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
Walking speed
4m walking test (4mWT), m/s
Measured: 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
Quality of life patient and caregiver
Visual analog scale of quality of life (VAS QoL), 0-10 a higher score means a better outcome
Measured: 3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at end of week 6 after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start28 Mar 2022
- Primary completion27 Mar 2023
- Study completion27 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Margaretha van Dijk, KU Leuven
- Investigators
- Johan Flamaing, PhD, MD, Principal investigator, KU UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419284
- Sponsor's protocol ID
- S66154
- Status last verified
- Sep 2023
- First submitted
- 18 May 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Geriatric Activation Program Pellenberg With the Informal Caregiver as Exercise Partner of the Physiotherapist (GAPP+Care)
- ClinicalTrials.gov ID
- NCT05419284
- Acronym / sponsor ID
- S66154
- Conditions
- Hip Fractures, Stroke, Frailty
- Keywords
- geriatric patients, geriatric rehabilitation, physiotherapy, caregiver involvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 May 2023 (actual)
- First posted
- 15 Jun 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| patient | Experimental | Other: GAPP+CareGAPP+Care |
| caregiver | Experimental | Other: +Care+Care |
| healthcare professional of the ward | Other | Other: Observation of GAPP+Careobservation of GAPP+Care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- No available caregiver
- Unable to understand instructions
- Physical unable to support the patient
- Unable to understand instructions
- Healthcare providers
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 |
|---|---|---|
| GAPP+Carestandard physiotherapy 45 minutes per day, 5 day a week (GAPP) + 3 extra exercise sessions led by a caregiver (+Care) | Other | patient |
| +Care3 extra exercise moments led by a caregiver: one physiotherapist-caregiver-patient exercise session: the physiotherapist will educate and train the caregiver on the exercises and hands-on skills. Two caregiver-patient exercise sessions | Other | caregiver |
| Observation of GAPP+CareHealthcare workers in the geriatric rehabilitation ward will be interviewed on their opinions on GAPP+Care | Other | healthcare professional of the ward |
Primary outcome
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
10 secondary outcomes
Feasibility, appropriateness, and the hindering and facilitating factors of GAPP+Care
Time frame: 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
Time frame: up to 12 weeks
Retention rate of participants
Time frame: 1 year
Number of falls during the +Care sessions
Time frame: up to 12 weeks
Private physiotherapy after discharge
Time frame: 6 weeks
Use of the activity monitor MOX, Maastricht Instruments
Time frame: first week at baseline, first week after discharge (starting at day of discharge), and week 6 after discharge
Functional balance
Time frame: 3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at end of week 6 after discharge
Hand squeeze force
Time frame: 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
Walking speed
Time frame: 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
Quality of life patient and caregiver
Time frame: 3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at end of week 6 after discharge
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 6 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Johan Flamaing, PhD, MD principal investigator
KU UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GAPP+Care, +Care and Observation of GAPP+Care in people with Hip Fractures and Stroke, run by KU Leuven at 1 site 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 8 inclusion and 7 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 6 Sep 2023. 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 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?
Proportion of eligible individuals and their willingness to participate in GAPP+Care (time frame: 1 year). 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 6 Sep 2023.