Exercise Intervention in Institutionalized Elderly People

NCT ID: NCT01646632

Last Updated: 2012-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2013-02-28

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.

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.

Conditions

Fragility; Physical Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical exercise intervention

Progressive resistance training, balance training, functional training

Group Type: EXPERIMENTAL

Physical exercise intervention

Intervention Type: BEHAVIORAL

the experimental intervention included group- based progressive resistance training, balance training, and functional training, two times a week, one hour sessions, lasting 16 weeks.

Lifestyle counseling

Recreational sessions

Group Type: PLACEBO_COMPARATOR

Lifestyle counseling

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

strength training; muscle training; coordination training; leisure time activities without physical activity

Eligibility 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

Hanze University of Applied Sciences Groningen

OTHER

Sponsor Role: lead

Responsible Party

Mrs. Elizabeth Weening-Dijksterhuis

researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cees P van der Schans, Prof., PhD

Role: STUDY_CHAIR

Hanze University Applied Science Groningen The Netherlands

Locations

Hanze University Applied Sciences

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 20798482 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20881587 (View on PubMed)

Other Identifiers

ABR NL 24558.042.09

Identifier Type: -

Identifier Source: org_study_id