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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01204567
Other study ID # 2009/184a
Secondary ID
Status Completed
Phase N/A
First received September 10, 2010
Last updated August 23, 2012
Start date January 2010
Est. completion date August 2012

Study information

Verified date August 2012
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Data Protection Authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effect of aerobic fitness training on mental health (health-related quality of life),cognitive and physical capacity in older people discharge from hospital and to assess if further aerobic training at home enhances the effect.

Design: Randomized controlled trial conducted at Oslo University Hospital, department of Medicine in conjunction with Oslo University College. The subjects will be randomized into one intervention group (training group) or one control group.

Outcome measure:

Health-related quality of life Physical function Cognitive capacity Physical activity Body composition Physical activity level


Description:

Research has indicated that participation in a regular exercise program is an effective intervention to maintain and enhance cognitive and physical function in older individuals.Despite good evidence regarding the positive effects of exercise, a sedentary or inactive lifestyle is common among people over 65 years of old, especially among persons with chronic diseases. Research shows that good mental health and physical capacity is of vital importance for living independently in the community and we know that participation in physical activity offers good opportunities to extend years of active independent life. Nevertheless our knowledge is sparse regarding the evidence of effective programs for health promotion in groups of elderly, especially after discharge from hospital. Our knowledge is also sparse as to which intervention program is the most effective, group-based training or home- based training.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 70 Years and older
Eligibility Inclusion Criteria:

- 70 years or older

- Be able to perform the Timed Up and Go test without use of assistive device

Exclusion Criteria:

- Chronic disease with expected lifespan < 1 year

- Exercise regularly more than twice a week

- Cognitive impairment MMS < 24

- Assessed by a doctor not to tolerate aerobic exercises

- Exercise limiting cardiovascular or musculoskeletal disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Aerobic training
Group-based Aerobic Interval Training twice a week in 12 weeks, based on the Ulleval model. The Norwegian Ulleval Model is a group-based aerobic interval training program which is widely used in Scandinavian hospitals for patients with coronary disease. It is designed to improve physical capacity, body awareness and emotional well-being.

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital Oslo University College

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health-related quality of life. Short form Health Survey (SF-36, version 2 3 and 12 months No
Secondary Senior fitness test, Cognitive capacity, PASE 3 and 12 months No
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