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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01622829
Other study ID # S-602/2011
Secondary ID
Status Recruiting
Phase N/A
First received June 15, 2012
Last updated June 19, 2012
Start date February 2012
Est. completion date September 2013

Study information

Verified date June 2012
Source Heidelberg University
Contact Stephanie Intorp
Email intorp@stud.uni-heidelberg.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

This study tries to improve patient's activity by a "Prescription for Activity" led by physiotherapists in secondary health care setting.

Three groups are compared in regard to their increase of physical activity.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- aged 40-75 years

- self-dependent

- walk around at home alone

- German-speaking

- Ability to read and write

- Life expectancy > 6 months

- Stable disease process expected for the next 6 months

- Time spend in hospital: > 3 days, < 4 weeks

Exclusion Criteria:

- Patients suffering from dementia

- Planned participation in rehabilitation

- severe functional limitations that precluded any increase in physical activity

- not living independently

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
"Prescription for Activity" and individual instructions
Structured education. "Prescription for Activity". This contains an exercise programme which consists of a 30 minutes muscle strengthening exercises to be performed at home at least three times per week and an endurance sports, chosen by the patient, to be performed at least 2 times per week. Additional the physiotherapists advise them in being more active during their individual daily life ( e.g. using a bike for short distances, regular walking, abandon the lift/escalator).
Other:
"Prescription for Activity", without instructions
Prescription with exercise programme. "Prescription for activity". This contains an exercise program consisting of 30 minutes of muscle strengthening exercises to be performed at home at least three times per week, the patient also needs to perform in an endurance sport at least two times per week.
usual physiotherapy
physiotherapy, treatment as usual

Locations

Country Name City State
Germany Departement of Sports Medicine, University of Heidelberg Heidelberg

Sponsors (1)

Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in levels of physical activity at three months overall activity score measured in MET*h/week assessed by a modified "Recent Physical Activity Questionnaire" (RPAQ) - Change from Baseline in levels of physical activity at 3 months difference Baseline, 3 months Yes
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