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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01247636
Other study ID # S-03247
Secondary ID
Status Completed
Phase Phase 2
First received November 18, 2010
Last updated November 23, 2010
Start date January 2005
Est. completion date January 2007

Study information

Verified date January 2005
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Data Protection Authority
Study type Interventional

Clinical Trial Summary

The purpose of this randomized controlled trial is to evaluate the effectiveness of an exercised-based programme developed for older people admitted at a geriatric outpatient clinic and to see if a home-exercise program enhances the effect. The outcomes considered is health-related quality of life, balance-self confidence, balance and mobility.


Description:

Older people discharge from hospital often have decreased functional and physiological reserve that make them vulnerable of being dependent of others. Research have shown that older people discharge from hospital are vulnerable for functional decline during hospital stay and this decline can persist 6 to 18 months after discharge from hospital.Exercise interventions are proven to have effect on mobility, balance and falls among community-dwelling older people and several studies have shown that deconditioning as a consequence of disuse is reversible with training even in very old individuals. However, few studies have evaluated the effects of physical activity promotion and exercise intervention among elderly recently discharge from a geriatric outpatient clinic.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- home-dwelling patients who were admitted at the geriatric clinic.

- Assessed by a doctor to tolerate training

- Able to walk in the corridor for 3 min with or without assistive device

Exclusion Criteria:

- Cognitive disorders mini mental status < 24

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:
Balance- training and home-exercise
Balance-training admitted at the geriatric hospital Home-exercise or advice to be generally active
Balance-training and home-exercise
The aim of the intervention was to enhance health-related quality of life, self-efficacy and physical function through education and exercise. The education program consisted of information given both oral and in writing regarding the benefits of physical activity. The aim was to increase the participants knowledge about the benefits of physical activity and to stimulate them to integrate physical activity into their immediate environment during daily routines. They were given an exercise-log and were advised to write down all their daily activities and exercise. The exercise program were conducted 2 times per week for 45 min per session. The content of these sessions were balance training with main focus on balance-exercises considered essential for daily living.

Locations

Country Name City State
Norway Ulleval University Hospital Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital Norwegian Fund for Postgraduate Training in Physiotherapy

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health-related quality of life by the time of discharge mean 2 weeks after admission No
Primary Health-related quality of life 3 months No
Secondary Functional balance (Berg Balance Scale) by the time of discharge mean 2 weeks after admission and after 3 months No
Secondary Functional mobility Timed up and go test and 6 min walk test by the time of discharge mean 2 weeks after admission, and after 3 months No
Secondary Functional strength by the time of discharge mean 2 weeks after admission and after 3 months No
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