Effectiveness of the Geriatric Activation Program Pellenb... | NCT03109483

Studies
Effectiveness of the Geriatric Activation Program Pellenberg (GAPP) on the Geriatric Rehabilitation Ward

NCT03109483

Sponsor

KU Leuven

Status

Completed

Last Update Posted

Jul 23, 2019Actual

Enrollment

111Actual

Phase

Not Applicable

Conditions

Stroke
Hip Fractures
Abdominal Injury
Chronic Obstructive Pulmonary Disease

Interventions

Geriatric Activation Program Pellenberg

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2017Actual

Primary Completion Date

Mar 30, 2019Actual

Completion Date

Mar 30, 2019Actual

First Submitted Date

Apr 3, 2017

First Submission Date that Met QC Criteria

Apr 11, 2017

First Posted Date

Apr 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2019

Last Update Posted Date

Jul 23, 2019Actual

Name	Class
Universitaire Ziekenhuizen KU Leuven	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

111Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Geriatric Activation Program Pellenberg	Other	intensive multicomponent physical therapy week program	Other: Geriatric Activation Program Pellenberg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Geriatric Activation Program Pellenberg	Other	intensive multicomponent physical therapy week program	Geriatric Activation Program Pellenberg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Independence for activities of daily living	Independence for ADL measured with the Basic-ADL	four weeks
Functional Balance	Functional balance measured with the Berg Balance Scale	four weeks

Secondary Outcomes

Measure	Description	Time Frame
Walking speed	Walking speed measured with the 10m walking test	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

medically instable
not able to understand the questions and tasks of the program or testing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitaire Ziekenhuizen Leuven, campus Pellenberg		Pellenberg		3212	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D006620	Hip Fractures
D000007	Abdominal Injuries
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided