Physical ActivityNCT04350983
Physical Activity on Prescription and Enhanced Individual Support by Physiotherapist
An observational study of Physical Activity and Sedentary Behavior, run by Vastra Gotaland Region.
Trial summary
Multimorbidity is common, especially in the elderly population and is associated with a higher risk of mortality and disability, lower quality of life, polypharmacy, increased healthcare use and costs. Read more about this study
- Who is it for?
- Ages 20 to 93 years
- Conditions the study is for
- Physical Activity, Sedentary Behavior, Multimorbidity
- What is being tested?
- Increased physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 331 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Apr 2020
- Phase
- Observational
- 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 20 to 93 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of men and women aged 20-93 years who received PAP from health care and enhanced individual support by physiotherapist at PAP-reception in wellness centre in central and western Gothenburg in 2015-2016. The majority of the study population had a multimorbidity and the most common diagnosis was musculoskeletal disease.
Who may be able to join
- Received physical activity on prescription from health care
- Contact with PAP-reception
Who cannot join
None listed.
About this study
Official title: Physical Activity on Prescription and Enhanced Individual Support by Physiotherapist A Comparative Study Between Individuals With One Diagnosis and Multimorbidity
Multimorbidity is common, especially in the elderly population and is associated with a higher risk of mortality and disability, lower quality of life, polypharmacy, increased healthcare use and costs. Physical inactivity increases the risk of multimorbidity and individuals with multimorbidity are more likely to be physically inactive. Physical activity can prevent and treat several diseases. Physical Activity on Prescription (PAP) is an evidence-based method used in health care to increase physical activity. The aim of this study was to investigate whether self-reported physical activity level increase and sedentary time decreases in individuals who have received PAP in health care completed with enhanced individual support by physiotherapist at PAP-reception in wellness center for six months and to compare individuals with one diagnosis to individuals with multimorbidity.
The study population consisted of 331 adults who received PAP in health care and enhanced individual support by a physiotherapist at PAP-reception during six months. Data has been collected retrospectively from a local register with questionnaires from the PAP-reception. Self reported physical activity minutes/week and hours of sedentary time/day were measured at baseline and at six months. Differences in physical activity minutes and sedentary time from baseline to six months have been compared between individuals with one diagnosis and individuals with multimorbidity.
- Conditions
- Physical Activity, Sedentary Behavior, Multimorbidity
- Being tested
- Increased physical activity
- Keywords
- Physical activity on prescription, Individual support, Enhanced support, Person-centered care, Physiotherapist
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased physical activityBehavioural
PAP and enhanced individual support by physiotherapist to increase physical activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity minutes/week
Self-assessment of two physical activity questions
Measured: Change between baseline and six months follow up.
Sedentary time hours/day
Self-assessment of one sedentary behaviour question
Measured: Change between baseline and six months follow up.
Secondary outcomes (3)
Diagnoses
Type and number of diagnoses
Measured: Measured at baseline
Visits and telephone contacts
Number of visits and telephone contacts
Measured: Measured at six months follow up
Socia demographic data
Age (years), sex (female/male)
Measured: Measured at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Jan 2015
- Primary completion31 Dec 2016
- Study completion1 Apr 2020
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.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elin Laurila, Vastra Gotaland Region
- Investigators
- Maria Larsson, PhD, Principal investigator, Sahlgrenska academy, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350983
- Sponsor's protocol ID
- PAP enhanced support 271821
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that supports the findings of this study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity on Prescription and Enhanced Individual Support by Physiotherapist A Comparative Study Between Individuals With One Diagnosis and Multimorbidity
- ClinicalTrials.gov ID
- NCT04350983
- Acronym / sponsor ID
- PAP enhanced support 271821
- Conditions
- Physical Activity, Sedentary Behavior, Multimorbidity
- Keywords
- Physical activity on prescription, Individual support, Enhanced support, Person-centered care, Physiotherapist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 17 Apr 2020 (actual)
- 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.
Multimorbidity is common, especially in the elderly population and is associated with a higher risk of mortality and disability, lower quality of life, polypharmacy, increased healthcare use and costs. Physical inactivity increases the risk of multimorbidity and individuals with multimorbidity are more likely to be physically inactive. Physical activity can prevent and treat several diseases. Physical Activity on Prescription (PAP) is an evidence-based method used in health care to increase physical activity. The aim of this study was to investigate whether self-reported physical activity level increase and sedentary time decreases in individuals who have received PAP in health care completed with enhanced individual support by physiotherapist at PAP-reception in wellness center for six months and to compare individuals with one diagnosis to individuals with multimorbidity.
The study population consisted of 331 adults who received PAP in health care and enhanced individual support by a physiotherapist at PAP-reception during six months. Data has been collected retrospectively from a local register with questionnaires from the PAP-reception. Self reported physical activity minutes/week and hours of sedentary time/day were measured at baseline and at six months. Differences in physical activity minutes and sedentary time from baseline to six months have been compared between individuals with one diagnosis and individuals with multimorbidity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 93 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of men and women aged 20-93 years who received PAP from health care and enhanced individual support by physiotherapist at PAP-reception in wellness centre in central and western Gothenburg in 2015-2016. The majority of the study population had a multimorbidity and the most common diagnosis was musculoskeletal disease.
Key inclusion criteria (2 listed)
- Received physical activity on prescription from health care
- Contact with PAP-reception
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Increased physical activityPAP and enhanced individual support by physiotherapist to increase physical activity | Behavioural | – |
Primary outcome
Physical activity minutes/week
Time frame: Change between baseline and six months follow up.
Self-assessment of two physical activity questions
Sedentary time hours/day
Time frame: Change between baseline and six months follow up.
Self-assessment of one sedentary behaviour question
3 secondary outcomes
Diagnoses
Time frame: Measured at baseline
Visits and telephone contacts
Time frame: Measured at six months follow up
Socia demographic data
Time frame: Measured at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Individual participant dataSharing planned: Yes. The data that supports the findings of this study are available from the corresponding author on reasonable request.
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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.
Maria Larsson, PhD principal investigator
Sahlgrenska academy, University of Gothenburg
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity and Sedentary Behavior, run by Vastra Gotaland Region.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity minutes/week (time frame: Change between baseline and six months follow up.). The study lists 2 primary outcomes in all. 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 17 Apr 2020.