Physical ActivitySRSNCT02552134
Standardised Regional Sport-club Based Exercise Programmes
A study testing exercise training and recommendation to be active in people with Physical Activity, run by Sportunion Österreich at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- exercise training and recommendation to be active
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Physical Activity
- Being tested
- exercise training, recommendation to be active
- Keywords
- Access to physical activity resources, community based exercise programme, sports-clubs, health resort,
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingOther
recommendation to be activeOther
| Study group | Role | What they receive |
|---|---|---|
| frequent participation | Experimental | 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. Receives: Other: exercise training |
| medium participation | Experimental | 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 Receives: Other: exercise training |
| low participation | Experimental | 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 Receives: Other: exercise training |
| recommendation to be active | Active comparator | 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". Receives: Other: recommendation to be active |
What is being measured
The primary outcome is the main question the study is designed to answer.
the weekly level of accelerometer determined health enhancing physical activity, measured as minutes of moderate and vigorous physical activity
Measured: 7 complete consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startOct 2016
- Primary completionMar 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sportunion Österreich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvia Titze, Dr, Study chair, Institut für Sportwissenschaften der Karl-Franzens-Universität Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552134
- Sponsor's protocol ID
- SPU HEPA
- Acronym
- SRS
- Status last verified
- Sep 2015
- First submitted
- 15 Sep 2015
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lackinger C, Strehn A, Dorner TE, Niebauer J, Titze S. Health resorts as gateways for regional, standardised, sports club based exercise programmes to increase the weekly time of moderate- to vigorous-intensity physical activity: study protocol. BMC Public Health. 2015 Dec 21;15:1265. doi: 10.1186/s12889-015-2581-9.
PubMed 26692015
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEPA Steiermark: Standardised Regional Sport-club Based Exercise Programmes
- ClinicalTrials.gov ID
- NCT02552134
- Acronym / sponsor ID
- SRS / SPU HEPA
- Conditions
- Physical Activity
- Keywords
- Access to physical activity resources, community based exercise programme, sports-clubs, health resort,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Sportunion ÖsterreichUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| frequent participation | Experimental | Other: exercise trainingAfter 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. |
| medium participation | Experimental | Other: exercise trainingAfter 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 |
| low participation | Experimental | Other: exercise trainingAfter 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 |
| recommendation to be active | Active comparator | Other: recommendation to be activeDuring 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". |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise training | Other | frequent participation, low participation, medium participation |
| recommendation to be active | Other | recommendation to be active |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
- Derived from this study: PubMed 26692015Lackinger C, Strehn A, Dorner TE, Niebauer J, Titze S. Health resorts as gateways for regional, standardised, sports club based exercise programmes to increase the weekly time of moderate- to vigorous-intensity physical activity: study protocol. BMC Public Health. 2015 Dec 21;15:1265. doi: 10.1186/s12889-015-2581-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia Titze, Dr study chair
Institut für Sportwissenschaften der Karl-Franzens-Universität Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training and recommendation to be active in people with Physical Activity, run by Sportunion Österreich at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Lackinger, Dr (+4366460613311, c.lackinger@sportunion.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02552134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2015.