StrokeNCT03109483
Effectiveness of the Geriatric Activation Program Pellenberg (GAPP) on the Geriatric Rehabilitation Ward
A study testing Geriatric Activation Program Pellenberg in people with Stroke and Hip Fractures, run by KU Leuven at 1 site in Belgium.
Trial summary
The aim of this study is to investigate the effectiveness of our developed week-treatment program GAPP, on strength, balance, speed, functionality and cognition, with the main goal to achieve a better independence for activities of daily living (ADL). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Stroke, Hip Fractures, Abdominal Injury
- What is being tested?
- Geriatric Activation Program Pellenberg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Mar 2017to 30 Mar 2019
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- admitted to the geriatric rehabilitation ward of UZ Leuven, campus Pellenberg
- the ability to walk 10m with help of a person or walking aid
- an expected stay of at least four weeks
- a signed informed consent
Who cannot join
- medically instable
- not able to understand the questions and tasks of the program or testing
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Universitaire Ziekenhuizen Leuven, campus Pellenberg
Pellenberg, 3212
About this study
The aim of this study is to investigate the effectiveness of our developed week-treatment program GAPP, on strength, balance, speed, functionality and cognition, with the main goal to achieve a better independence for activities of daily living (ADL).
Each day of the week an exercise program of 45 minutes is given assigned to a specific aspect of the rehabilitation; strength, balance, speed, functional training and one day is for testing or group therapy.
Participants will be followed for four weeks, with testing on day one, after two weeks and at the last day of the four-week program.
Read the detailed description
The aim of this study is to investigate the effectiveness of our developed week-treatment program GAPP (Geriatric Activation Program Pellenberg), on strength, balance, speed, functionality and cognition, with the main goal to achieve a better independence for ADL.
Each day of the week an exercise program of 45 minutes is given assigned to a specific aspect of the rehabilitation.
Monday: speed and coordination, including as many repetitions as possible in one minute for: quick arm movements in standing, quick trunk movements in sitting, quick weight transfers in standing, stepping.
Tuesday: functional training, including walking stairs, transfers, sitting to lying and reverse, moving objects in the room, functional fit-o-meter.
Wednesday: balance, including maximum weight transfers in all directions, exercises with reduced base of support, reaching.
Thursday: strength, including sit to stand with a weight belt, lifting a weight bimanual of the table, walking with ankle weights, arm extension with therapy bands.
Friday: testing or group activity. One week the following test will be taken: Berg Balance Scale, 10m walking test, Digit Symbol Substitution Test, knee extension and elbow extension strength with the microfet2, Basic-ADL and Geriatric Depression Scale.
The other week there will be a group session, this could be in sitting (like moving on music) or standing (like petanque).
Walking will be practiced every day of the week and individual needs (like specific hand rehabilitation or pain problems) will be addressed besides the program when needed.
- Being tested
- Geriatric Activation Program Pellenberg
- Keywords
- geriatric patients, elderly, multicomponent physical therapy
- Medical subject headings
- Stroke, Hip Fractures, Abdominal Injuries, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric Activation Program PellenbergOther
intensive multicomponent physical therapy week program
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Activation Program Pellenberg | Other | intensive multicomponent physical therapy week program Receives: Other: Geriatric Activation Program Pellenberg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Independence for activities of daily living
Independence for ADL measured with the Basic-ADL
Measured: four weeks
Functional Balance
Functional balance measured with the Berg Balance Scale
Measured: four weeks
Secondary outcomes (5)
Walking speed
Walking speed measured with the 10m walking test
Measured: four weeks
Strength of arm Extension
Strength of arm extension, measured with the microFET2 hand held dynamometer. The mean peak force in Newton of three trail will be used.
Measured: four weeks
Strength of knee extension
Strength of Knee extension, measured with the microFET2 hand held dynamometer. The mean peak force in Newton of three trail will be used.
Measured: four weeks
Cognitive function
The Digit Symbol Substitution Test will be used to measure response speed, sustained attention
Measured: four weeks
General state of mind
General state of mind measured with the Geriatric Depression Scale 15
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start17 Mar 2017
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- explorative study
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Margreet van Dijk, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109483
- Sponsor's protocol ID
- S59948 / B322201731432
- Status last verified
- Jul 2019
- First submitted
- 3 Apr 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Geriatric Activation Program Pellenberg (GAPP) on the Geriatric Rehabilitation Ward
- ClinicalTrials.gov ID
- NCT03109483
- Acronym / sponsor ID
- S59948 / B322201731432
- Keywords
- geriatric patients, elderly, multicomponent physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 12 Apr 2017 (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.
The aim of this study is to investigate the effectiveness of our developed week-treatment program GAPP, on strength, balance, speed, functionality and cognition, with the main goal to achieve a better independence for activities of daily living (ADL).
Each day of the week an exercise program of 45 minutes is given assigned to a specific aspect of the rehabilitation; strength, balance, speed, functional training and one day is for testing or group therapy.
Participants will be followed for four weeks, with testing on day one, after two weeks and at the last day of the four-week program.
Detailed description
The aim of this study is to investigate the effectiveness of our developed week-treatment program GAPP (Geriatric Activation Program Pellenberg), on strength, balance, speed, functionality and cognition, with the main goal to achieve a better independence for ADL.
Each day of the week an exercise program of 45 minutes is given assigned to a specific aspect of the rehabilitation.
Monday: speed and coordination, including as many repetitions as possible in one minute for: quick arm movements in standing, quick trunk movements in sitting, quick weight transfers in standing, stepping.
Tuesday: functional training, including walking stairs, transfers, sitting to lying and reverse, moving objects in the room, functional fit-o-meter.
Wednesday: balance, including maximum weight transfers in all directions, exercises with reduced base of support, reaching.
Thursday: strength, including sit to stand with a weight belt, lifting a weight bimanual of the table, walking with ankle weights, arm extension with therapy bands.
Friday: testing or group activity. One week the following test will be taken: Berg Balance Scale, 10m walking test, Digit Symbol Substitution Test, knee extension and elbow extension strength with the microfet2, Basic-ADL and Geriatric Depression Scale.
The other week there will be a group session, this could be in sitting (like moving on music) or standing (like petanque).
Walking will be practiced every day of the week and individual needs (like specific hand rehabilitation or pain problems) will be addressed besides the program when needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- explorative study
| Arm | Type | Receives |
|---|---|---|
| Geriatric Activation Program Pellenberg | Other | Other: Geriatric Activation Program Pellenbergintensive multicomponent physical therapy week program |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- admitted to the geriatric rehabilitation ward of UZ Leuven, campus Pellenberg
- the ability to walk 10m with help of a person or walking aid
- an expected stay of at least four weeks
- a signed informed consent
Key exclusion criteria (2 listed)
- medically instable
- not able to understand the questions and tasks of the program or testing
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 |
|---|---|---|
| Geriatric Activation Program Pellenbergintensive multicomponent physical therapy week program | Other | Geriatric Activation Program Pellenberg |
Primary outcome
Independence for activities of daily living
Time frame: four weeks
Independence for ADL measured with the Basic-ADL
Functional Balance
Time frame: four weeks
Functional balance measured with the Berg Balance Scale
5 secondary outcomes
Walking speed
Time frame: four weeks
Strength of arm Extension
Time frame: four weeks
Strength of knee extension
Time frame: four weeks
Cognitive function
Time frame: four weeks
General state of mind
Time frame: four weeks
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 23 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric Activation Program Pellenberg in people with Stroke and Hip Fractures, 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 4 inclusion and 2 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 23 Jul 2019. 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?
Independence for activities of daily living (time frame: four weeks). The study lists 2 primary outcomes in all. 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 23 Jul 2019.