- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02552134
Standardised Regional Sport-club Based Exercise Programmes (SRS)
HEPA Steiermark: Standardised Regional Sport-club Based Exercise Programmes
Background: More than 10% of the adult population in Styria, a federal state in the south of Austria, is allotted to a stationary stay at a health resort each year. In practice approximately 50.000 adults receive these stays that are financed from the health insurance companies and that last up to 3 weeks. The target group for theses stays is the general population aged between 30 and 65 years that shows minor health deficits like back pain or risk factors for cardio-metabolic diseases. The treatment during the stays consists of exercise, nutritional and psychological interventions. Thus the increase of physical activity is an important goal that is focussed during the stationary stay. Because of the absence of regional facilities that are linked to the resorts and that provide accesses to standardised regional programmes sustainability is questionable.
Methods/Design: This prospective controlled open label study compares two study groups. After a stationary stay at a health resort patient are allocated to a standardised, regional sports-club based exercise programme or to another group, where only written hand-outs are provided. The primary outcome is the weekly level of health enhancing physical activity which is objectively measured with an accelerometer and an activity log-book. Additionally, social determinants are requested, fitness and anthropometric measurements are done at baseline until 12 months. Beside the changes in measurable parameters, processes are evaluated accurately. Consequently the gateway - function of the health resort is analysed.
Discussion: The structured cooperation between the health sector, where health resorts informing and assigning patients to regional sports-clubs and the sports sector potentially provides a wide network of standardised programmes. Within this study we aim to evaluate the sustainability of stationary stays and a continuing regional standardised exercise programme.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Styria
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Graz, Styria, Austria, 8020
- Recruiting
- University of Graz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Austrian physical activity recommendations for substantial health benefits are not reached. (Weekly < 150 Minutes of aerobic moderate intense physical activity, or < 75 minutes of aerobic vigorous intense physical activity or an equal combination as well as and/or muscle-strengthening activities at least twice a week are not realised.)
- Stationary stay at a health resort
- Physical activity in the patient's responsibility is recommended
- Systolic blood pressure at rest ≤ 90 mm/Hg
- Diastolic blood pressure at rest ≤ 140 mm/Hg
Exclusion Criteria:
- More than 10% planned or unplanned weight loss / weight gain during the last 6 months
- Pregnancy
- Indication for stationary or outpatient rehabilitation based on the
- Untreated coronary heart disease
- Untreated micro- or macrovascular artery disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: frequent participation
After termination of a stationary stay in a health resort, participants will visit an initial standardised regional sport club based exercise programme for 12 sessions at the place of the residence.
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Experimental: medium participation
After termination of a stationary stay in a health resort, participants will visit an initial standardised regional sport club based exercise programme for 12 sessions at the place of the residence
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Experimental: low participation
After termination of a stationary stay in a health resort, participants will visit an initial standardised regional sport club based exercise programme for 12 sessions at the place of the residence
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Active Comparator: recommendation to be active
During the stay in the health care resort participants are introduced to be active in the future.
They will receive a brochure "Physical Activity: Health for all".
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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the weekly level of accelerometer determined health enhancing physical activity, measured as minutes of moderate and vigorous physical activity
Time Frame: 7 complete consecutive days
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7 complete consecutive days
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sylvia Titze, Dr, Institut für Sportwissenschaften der Karl-Franzens-Universität Graz
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SPU HEPA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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