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Exercise Intervention in Institutionalized Elderly People (BENENFIT)

This study is ongoing, but not recruiting participants.
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
History of Changes
  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:

U.S. FDA Resources

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
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 May 23, 2013