CClinicalTrials.gg
Status unknownNCT01646632BENENFITUpdated Jul 20, 2012

Exercise Intervention in Institutionalized Elderly People

A Phase 2 interventional study of Physical exercise intervention and Lifestyle counseling in Fragility and Physical Disability, sponsored by Hanze University of Applied Sciences Groningen. Status unknown at 1 site in Netherlands. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-20.

Sponsored by Hanze University of Applied Sciences Groningen · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
70 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Fragility
  • Physical Disability

Keywords

  • institutionalized ADL fitness care-dependency
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In context

Lead sponsor

Hanze University of Applied Sciences Groningen is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 70 and older
  • Being able to walk at least 10 meters
  • Not cognitive impaired

Exclusion criteria

Exclusion Criteria:

  • Dementia
  • Severe hart failure
  • Progressive neurological diseases
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
164 participants (actual)

Study arms

  • Experimental
    Physical exercise intervention

    Progressive resistance training, balance training, functional training

    Behavioral: Physical exercise intervention

  • Placebo comparator
    Lifestyle counseling

    Recreational sessions

    Behavioral: Lifestyle counseling

Interventions

  • BehavioralPhysical 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.

    Also known as: strength training, muscle training, coordination training

  • BehavioralLifestyle counseling

    the control intervention included recreational sessions, including talks, video's, music, board games etc. No physical activity was involved in the control intervention.

    Also known as: leisure time activities without physical activity

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What researchers measure

Primary outcomes

  1. ADL performance in institutionalized elderly people

    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

    Time frame: 16 weeks

Secondary outcomes

  1. Physical fitness in institutionalized older people

    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

    Time frame: 16 weeks

  2. Care dependency in institutionalized older people

    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

    Time frame: 16 weeks

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Study locations

1 site
  • Hanze University Applied Sciences
    Groningen, 9714 CE, Netherlands
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References and documents

Publications

  • 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. PubMed 20798482 ↗
  • 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. PubMed 20881587 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01646632
Lead sponsor
Hanze University of Applied Sciences Groningen
Collaborators
University Medical Center Groningen
Responsible party
Mrs. Elizabeth Weening-Dijksterhuis (researcher, Hanze University of Applied Sciences Groningen) — Principal investigator
First posted
Jul 20, 2012
Start date
Oct 2009
Primary completion
Dec 2012 (estimated)
Completion
Feb 2013 (estimated)
Last update
Jul 20, 2012

Study contacts

Cees P van der Schans, Prof., PhD
study chair · Hanze University Applied Science Groningen The Netherlands

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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