Exercise Intervention in Institutionalized Elderly People (BENENFIT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hanze University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University Medical Centre Groningen
Information provided by (Responsible Party):
Mrs. Elizabeth Weening-Dijksterhuis, Hanze University
ClinicalTrials.gov Identifier:
NCT01646632
First received: July 11, 2012
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Fragility
Physical Disability
Behavioral: Physical exercise intervention
Behavioral: Lifestyle counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Exercise on ADL Performance, Physical Fitness, and Care Dependency in Institutionalized Elderly People

Resource links provided by NLM:


Further study details as provided by Hanze University:

Primary Outcome Measures:
  • ADL performance in institutionalized elderly people [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Physical fitness in institutionalized older people [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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

  • Care dependency in institutionalized older people [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 164
Study Start Date: October 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical exercise intervention
Progressive resistance training, balance training, functional training
Behavioral: Physical exercise intervention
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:
  • strength training
  • muscle training
  • coordination training
Placebo Comparator: Lifestyle counseling
Recreational sessions
Behavioral: Lifestyle counseling
the control intervention included recreational sessions, including talks, video's, music, board games etc. No physical activity was involved in the control intervention.
Other Name: leisure time activities without physical activity

Detailed Description:

To improve physical fitness, a combined exercise program including progressive resistance training, balance training, and functional training will be used in a sample of institutionalized elderly people. The exercise program has a frequency of 2 times a week and a duration of 16 weeks. The intensity is moderate, measured on a 0-10 scale. The level of intensity is specified as follows: on a 10- point scale, where no movement is 0 and maximal effort of a muscle group is 10, moderate-intensity effort is a 5 or 6, and high- intensity effort is a 7 or 8. There is currently insufficient evidence that a combined exercise program, developed to improve physical fitness, can improve ADL performance and care dependency also.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01646632

Locations
Netherlands
Hanze University Applied Sciences
Groningen, Netherlands, 9714 CE
Sponsors and Collaborators
Hanze University
University Medical Centre Groningen
Investigators
Study Chair: Cees P van der Schans, Prof., PhD Hanze University Applied Science Groningen The Netherlands
  More Information

Publications:
Responsible Party: Mrs. Elizabeth Weening-Dijksterhuis, researcher, Hanze University
ClinicalTrials.gov Identifier: NCT01646632     History of Changes
Other Study ID Numbers: ABR NL 24558.042.09
Study First Received: July 11, 2012
Last Updated: July 18, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Hanze University:
institutionalized ADL fitness care-dependency

ClinicalTrials.gov processed this record on September 22, 2014