- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01646632
Exercise Intervention in Institutionalized Elderly People (BENENFIT)
Effects of Exercise on ADL Performance, Physical Fitness, and Care Dependency in Institutionalized Elderly People
Questions: Does an evidence-based exercise program increase activities of daily living and physical fitness in institutionalized older adults? Does this program decrease the care dependency of institutionalized older adults? Design: A randomized control trial using group-based exercise was performed in 14 assisted-living facilities for the elderly (>70 years old).
Outcome measures: Outcome measures were performance on ADL, physical fitness, and care dependency measures. The exercise program comprised group-based progressive resistance training, balance training, and functional training. The control intervention comprised social group meetings.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Groningen, Netherlands, 9714 CE
- Hanze University Applied Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 70 and older
- Being able to walk at least 10 meters
- Not cognitive impaired
Exclusion Criteria:
- Dementia
- Severe hart failure
- Progressive neurological diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical exercise intervention
Progressive resistance training, balance training, functional training
|
the experimental intervention included group- based progressive resistance training, balance training, and functional training, two times a week, one hour sessions, lasting 16 weeks.
Other Names:
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Placebo Comparator: Lifestyle counseling
Recreational sessions
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the control intervention included recreational sessions, including talks, video's, music, board games etc.
No physical activity was involved in the control intervention.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADL performance in institutionalized elderly people
Time Frame: 16 weeks
|
the intervention was either an group -based exercise program (the experimental intervention), or a recreational program (the control intervention), lasting 16 weeks, two times a week, including one hour sessions
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical fitness in institutionalized older people
Time Frame: 16 weeks
|
the intervention was either an group -based exercise program (the experimental intervention), or a recreational program (the control intervention), lasting 16 weeks, two times a week, including one hour sessions
|
16 weeks
|
Care dependency in institutionalized older people
Time Frame: 16 weeks
|
the intervention was either an group -based exercise program (the experimental intervention), or a recreational program (the control intervention), lasting 16 weeks, two times a week, including one hour sessions
|
16 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Cees P van der Schans, Prof., PhD, Hanze University Applied Science Groningen The Netherlands
Publications and helpful links
General Publications
- Weening-Dijksterhuis E, de Greef MH, Scherder EJ, Slaets JP, van der Schans CP. Frail institutionalized older persons: A comprehensive review on physical exercise, physical fitness, activities of daily living, and quality-of-life. Am J Phys Med Rehabil. 2011 Feb;90(2):156-68. doi: 10.1097/PHM.0b013e3181f703ef.
- Weening-Dijksterhuis E, Kamsma YP, van Heuvelen MJ. Psychometric properties of the PAT: an assessment tool for ADL performance of older people living in residential homes. Gerontology. 2011;57(5):405-13. doi: 10.1159/000318151. Epub 2010 Aug 26.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ABR NL 24558.042.09
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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