- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01247636
Home-Exercise vs General Physical Activity: Effect on Health-related Quality of Life
November 23, 2010 updated by: Oslo University Hospital
Effect of Progressive Home-Exercise on Health-related Quality of Life, Balance and Mobility in Older People Discharge From an Outpatient Geriatric Clinic.
The purpose of this randomized controlled trial is to evaluate the effectiveness of an exercised-based programme developed for older people admitted at a geriatric outpatient clinic and to see if a home-exercise program enhances the effect.
The outcomes considered is health-related quality of life, balance-self confidence, balance and mobility.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Older people discharge from hospital often have decreased functional and physiological reserve that make them vulnerable of being dependent of others.
Research have shown that older people discharge from hospital are vulnerable for functional decline during hospital stay and this decline can persist 6 to 18 months after discharge from hospital.Exercise interventions are proven to have effect on mobility, balance and falls among community-dwelling older people and several studies have shown that deconditioning as a consequence of disuse is reversible with training even in very old individuals.
However, few studies have evaluated the effects of physical activity promotion and exercise intervention among elderly recently discharge from a geriatric outpatient clinic.
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Oslo, Norway
- Ullevål University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- home-dwelling patients who were admitted at the geriatric clinic.
- Assessed by a doctor to tolerate training
- Able to walk in the corridor for 3 min with or without assistive device
Exclusion Criteria:
- Cognitive disorders mini mental status < 24
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home-exercise
|
Balance-training admitted at the geriatric hospital Home-exercise or advice to be generally active
Other Names:
The aim of the intervention was to enhance health-related quality of life, self-efficacy and physical function through education and exercise.
The education program consisted of information given both oral and in writing regarding the benefits of physical activity.
The aim was to increase the participants knowledge about the benefits of physical activity and to stimulate them to integrate physical activity into their immediate environment during daily routines.
They were given an exercise-log and were advised to write down all their daily activities and exercise.
The exercise program were conducted 2 times per week for 45 min per session.
The content of these sessions were balance training with main focus on balance-exercises considered essential for daily living.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Health-related quality of life
Time Frame: 3 months
|
3 months
|
Health-related quality of life
Time Frame: by the time of discharge mean 2 weeks after admission
|
by the time of discharge mean 2 weeks after admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional balance (Berg Balance Scale)
Time Frame: by the time of discharge mean 2 weeks after admission and after 3 months
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by the time of discharge mean 2 weeks after admission and after 3 months
|
|
Functional mobility
Time Frame: by the time of discharge mean 2 weeks after admission, and after 3 months
|
Timed up and go test and 6 min walk test
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by the time of discharge mean 2 weeks after admission, and after 3 months
|
Functional strength
Time Frame: by the time of discharge mean 2 weeks after admission and after 3 months
|
by the time of discharge mean 2 weeks after admission and after 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Astrid Bergland, Professor, No afflication
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
November 18, 2010
First Submitted That Met QC Criteria
November 23, 2010
First Posted (Estimate)
November 24, 2010
Study Record Updates
Last Update Posted (Estimate)
November 24, 2010
Last Update Submitted That Met QC Criteria
November 23, 2010
Last Verified
January 1, 2005
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- S-03247
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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