Standardised Regional Sport-club Based Exercise Programmes

Physical Activity Clinical Trial

— SRS  

Official title:

HEPA Steiermark: Standardised Regional Sport-club Based Exercise Programmes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02552134
• Other study ID #: SPU HEPA
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2015
• Last updated: October 23, 2015
• Start date: October 2016
• Est. completion date: October 2018

Study information

• Verified date: September 2015
• Source: Sportunion Österreich
• Contact: Christian Lackinger, Dr
• Phone: +4366460613311
• Email: c.lackinger[@]sportunion.at
• Is FDA regulated: No
• Health authority: Austria: Gesundheitsfonds Steiermark
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: October 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Physical Activity

Intervention

Other:
• exercise training

• recommendation to be active

Locations

Country	Name	City	State
Austria	University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Sportunion Österreich

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the weekly level of accelerometer determined health enhancing physical activity, measured as minutes of moderate and vigorous physical activity		7 complete consecutive days	No