MedDataX Logo

Exercise Intervention in Institutionalized Elderly People

NCT ID: NCT01646632

Last Updated: 2012-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Fragility Physical Disability

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

institutionalized ADL fitness care-dependency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

University Medical Center Groningen

OTHER

Sponsor Role collaborator

Hanze University of Applied Sciences Groningen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mrs. Elizabeth Weening-Dijksterhuis

researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cees P van der Schans, Prof., PhD

Role: STUDY_CHAIR

Hanze University Applied Science Groningen The Netherlands

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hanze University Applied Sciences

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

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

Review additional registry numbers or institutional identifiers associated with this trial.

ABR NL 24558.042.09

Identifier Type: -

Identifier Source: org_study_id