Physical ActivityNCT01622829
Activity on Prescription to Promote Physical Activity in Hospitalized Patients
A study testing "Prescription for Activity" and individual instructions, "Prescription for Activity", without instructions and usual physiotherapy in people with Physical Activity, run by Heidelberg University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Physical Activity
- What is being tested?
- "Prescription for Activity" and individual instructions, "Prescription for Activity", without instructions and usual physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Sep 2013
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients suffering from dementia
- Planned participation in rehabilitation
- severe functional limitations that precluded any increase in physical activity
- not living independently
Trial locations and contacts
1 site in 1 country.
Stephanie Intorp contact
Germany1 site, 1 recruiting
- Recruiting
Departement of Sports Medicine, University of Heidelberg
Heidelberg, 69120
Peter Baertsch, MD, +496221568101, peter.bartsch@med.uni-heidelberg.de
About this study
Official title: Pilot Study on Physical Activity
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.
- Conditions
- Physical Activity
- Being tested
- "Prescription for Activity" and individual instructions, "Prescription for Activity", without instructions, usual physiotherapy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Prescription for Activity" and individual instructionsProcedure or surgery
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).
"Prescription for Activity", without instructionsOther
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 physiotherapyOther
physiotherapy, treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| group1 | Experimental | Usual Physiotherapy, additional: "Prescription for Activity" with a structured fitness program and individual instructions to become more active in the daily living situation Receives: Procedure: "Prescription for Activity" and individual instructions |
| group 2 | Experimental | usual Physiotherapy , additional: "Prescription for Activity" without instructions Receives: Other: "Prescription for Activity", without instructions |
| group 3 | No intervention | control, usual physiotherapy Receives: Other: usual physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Schommer, MD, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622829
- Sponsor's protocol ID
- S-602/2011
- Status last verified
- Jun 2012
- First submitted
- 15 Jun 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Physical Activity
- ClinicalTrials.gov ID
- NCT01622829
- Acronym / sponsor ID
- S-602/2011
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 19 Jun 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group1 | Experimental | Procedure: "Prescription for Activity" and individual instructionsUsual Physiotherapy, additional: "Prescription for Activity" with a structured fitness program and individual instructions to become more active in the daily living situation |
| group 2 | Experimental | Other: "Prescription for Activity", without instructionsusual Physiotherapy , additional: "Prescription for Activity" without instructions |
| group 3 | No intervention | Other: usual physiotherapycontrol, usual physiotherapy |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- aged 40-75 years
- self-dependent
- walk around at home alone
- German-speaking
- Ability to read and write
Key exclusion criteria (4 listed)
- Patients suffering from dementia
- Planned participation in rehabilitation
- severe functional limitations that precluded any increase in physical activity
- not living independently
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 |
|---|---|---|
| "Prescription for Activity" and individual instructionsStructured 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). | Procedure or surgery | group1 |
| "Prescription for Activity", without instructionsPrescription 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. | Other | group 2 |
| usual physiotherapyphysiotherapy, treatment as usual | Other | group 3 |
Primary outcome
Change from baseline in levels of physical activity at three months
Time frame: Baseline, 3 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
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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.
Stephanie Intorp contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Prescription for Activity" and individual instructions, "Prescription for Activity", without instructions and usual physiotherapy in people with Physical Activity, run by Heidelberg University at 1 site in Germany.
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 8 inclusion and 4 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 20 Jun 2012. 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 Germany. 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 Stephanie Intorp (intorp@stud.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in levels of physical activity at three months (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2012.