NCT01646632

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

July 20, 2012

Status Verified

July 1, 2012

Enrollment Period

3.2 years

First QC Date

July 11, 2012

Last Update Submit

July 18, 2012

Conditions

FragilityPhysical Disability

Keywords

institutionalized ADL fitness care-dependency

Outcome Measures

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

    16 weeks

Secondary Outcomes (2)

  • Physical fitness in institutionalized older people

    16 weeks

  • Care dependency in institutionalized older people

    16 weeks

Study Arms (2)

Physical exercise intervention

EXPERIMENTAL

Progressive resistance training, balance training, functional training

Behavioral: Physical exercise intervention

Lifestyle counseling

PLACEBO COMPARATOR

Recreational sessions

Behavioral: Lifestyle counseling

Interventions

Physical exercise interventionBEHAVIORAL

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
Physical exercise intervention
Lifestyle counselingBEHAVIORAL

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
Lifestyle counseling

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Dementia
  • Severe hart failure
  • Progressive neurological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanze University Applied Sciences

Groningen, Provincie Groningen, 9714 CE, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 20798482BACKGROUND

  • 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.

    PMID: 20881587BACKGROUND

MeSH Terms

Interventions

Resistance TrainingExercise

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Cees P van der Schans, Prof., PhD

    Hanze University Applied Science Groningen The Netherlands

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 20, 2012

Study Start

October 1, 2009

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

July 20, 2012

Record last verified: 2012-07

Locations

NL(1)