Physical InactivityUMEPANCT06658704
Understanding Motivation Towards Exercise to Enhance Physical Activity on Prescription Adherence
A study testing Supervised exercise in a group setting in people with Physical Inactivity, run by Umeå University at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to explore effectiveness on physical activity, function and psychometrics in relation to an exercise intervention in physically inactive middle-aged men and women. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Supervised exercise in a group setting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 6 Nov 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physically inactive persons as defined as not meeting the current recommendations of at least 150 minutes of moderate to vigorous physical activity per week. This criterion is self-assessed by potential participants.
- Age 40-60 years
Who cannot join
- Physical disability that affects the ability to perform the exercise intervention.
- Heart failure or severe degenerative disease, e.g. malignant cancer, multiple sclerosis etc.
- Myocardial infarction or stroke during the last 12 months.
- Heart conditions including angina pectoris that is worsened with exercise.
- Neuromuscular, musculoskeletal, or rheumatic conditions that is worsened with exercise.
- Hypertension grade III, i.e. systolic blood pressure above 180 mmHg and/or diastolic blood pressure over 110 mmHg.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to explore effectiveness on physical activity, function and psychometrics in relation to an exercise intervention in physically inactive middle-aged men and women. The main questions it aims to answer are:
- Is the exercise intervention effective in increasing physical activity, function and motivation towards exercise? Is there an intervention effect in physical activity, function and psychometrics at 6-, 12- and 24 months post baseline?
- Can barriers and facilitators towards increased physical activity be identified in the two groups of the study?
Read more
All participants will first receive standard care for physically inactive patients, i.e. Physical activity on Prescription (PaP), followed by allocation to an exercise intervention (EI) group or a control group. The EI group will be offered an additional exercise intervention for 16 weeks consisting of 1-2 training sessions per week of a combination of aerobic and resistance training at a private fitness centre. The control group will be asked to adhere to their PaP.
Researchers will assess physical activity, function and psychometrics in the two groups at 6-, 12- and 24 months to evaluate the intervention effect. Additionally, interviews with the participants in the control and EI groups will be performed in order to explore barriers and facilitators towards increased physical activity in formerly inactive patients.
- Conditions
- Physical Inactivity
- Being tested
- Supervised exercise in a group setting, Usual care (Physical activity on Prescription)
- Keywords
- Physical Inactivity, Exercise Referral Scheme, Physical activity on Prescription, Exercise intervention
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise in a group settingBehavioural
Participants are invited to a 16 week exercise intervention at a private fitness center after they have received their PaP. The exercise, including a variety of aerobic and resistance training, is performed in a group setting starting with one session per week for the first two weeks and then two sessions per week for week 3-16.
Usual care (Physical activity on Prescription)Behavioural
Participants are prescribed a Physical activity on Prescription (PaP) which means that they will have a motivational interview with a physiotherapist regarding increased physical activity. The physiotherapist will then prescribe a individualized PaP with the goal to increase weekly physical activity that the participant are instructed to adhere to for the remainder of the study. A follow-up session is also included after 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | Participants are prescribed a Physical activity on Prescription (PaP) which means that they will have a motivational interview with a physiotherapist regarding increased physical activity. The physiotherapist will then prescribe a individualized PaP with the goal to increase weekly physical activity that the participant are instructed to adhere to for the remainder of the study. A follow-up session is also included after 16 weeks. Participants are invited to a 16 week exercise intervention at a private fitness center after they have received their PaP. The exercise, including a variety of aerobic and resistance training, is performed in a group setting starting with one session per week for the first two weeks and then two sessions per week for week 3-16. Follow-up tests is also included after 6-, 12- and 24 months. Receives: Behavioral: Supervised exercise in a group setting; Behavioral: Usual care (Physical activity on Prescription) |
| Control | Active comparator | Participants are prescribed a Physical activity on Prescription (PaP) which means that they will have a motivational interview with a physiotherapist regarding increased physical activity. The physiotherapist will then prescribe a individualized PaP with the goal to increase weekly physical activity that the participant are instructed to adhere to for the remainder of the study. A follow-up session is also included after 16 weeks. Follow-up tests is also included after 6-, 12- and 24 months. Receives: Behavioral: Usual care (Physical activity on Prescription) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported exercise and physical activity
One question regarding exercise and one question regarding every day physical activity in a typical week. The question regarding exercise comprises 6 answer alternatives ranging from 0 min to more than 120 min per week. The question regarding every day physical activity comprises 7 answer alternatives raging from 0 min to more than 300 min per week. The questions are produced by the Swedish National Board of Health and Welfare.
Measured: Baseline, 6-, 12- and 24 months
Secondary outcomes (9)
Device measured physical activity level
Device measured physical activity, measured with an accelerometer for 7 consecutive days. Raw data are then recalculated to minutes spent in light, moderate and vigouros physical acticity intensity zones.
Measured: Baseline, 6-, 12- and 24 months
Daily step count
Data from device measured physical activity, measured with an accelerometer for 7 consecutive days, are used to collect daily step counts.
Measured: Baseline, 6-, 12- and 24 months
Cardio-respiratory capacity
Ekblom-Bak cycle ergometer test will be used to assess cardio-respiratory fitness.
Measured: Baseline, 6-, 12- and 24 months
Upper limb strength
Hand grip strength of the non dominant hand is measured with a hand dynamometer to the nearest kg. Three consecutive trials is performed in a seated position with the elbow held at a 90 degree angle and the highest value is recorded. A higher value indicate higher upper limb strength.
Measured: Baseline, 6-, 12- and 24 months
Lower limb muscle strength
Five repetition sit to stand test. From a seated position, the participant is instructed to stand up and then sit down again for a total of five times. The total time of five repetition sit to stand cycles is then recorded in seconds with a stopwatch. A lower total time indicate higher lower limb muscle strength.
Measured: Baseline, 6-, 12- and 24 months
Motivational stages of self-determination for exercise
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) will be used. The questionnaire contains 19 questions, belonging to one of the five categories Amotivation, External regulation, Introjected regulation, Identified regulation and Intrinsic regulation. The scale assesses where a person is on the continuum of self-determination in where higher, positive scores indicate greater relative autonomy; lower, negative scores indicate more controlled regulation.
Measured: Baseline, 6-, 12- and 24 months
Confidence in one's own ability to exercise
The Swedish Exercise Self-Efficacy Scale (ESES-S) will be used. The questionnaire comprises 10 questions on exercise self-efficacy, each with four answer alternatives. The composite score ranges from 10 to 40 and a higher score indicate a higher precised self-efficacy towards exercise.
Measured: Baseline, 6-, 12- and 24 months
Basic psychological needs connected to physical activity satisfaction
The Basic Psychological Needs in Exercise Scale (BPNES) will be used. This questionnaire contains 12 questions related to one of three basic psychological needs; Autonomy, Competence and Relatedness in the exercise domain. Answers are given on a five point Likert scale and results are presented for the individual needs and as a collective, global need. The maximal score for each question is 5 and the minimal score is 1. Mean values for each need is presented together with a mean score of all 12 questions. A higher score indicate a higher need fulfillment.
Measured: Baseline, 6-, 12- and 24 months
Health related quality of life
RAND-36 health survey will be used (RAND is not an acronym but the name of a research corporation). The RAND-36 survey contains 36 questions belonging to eight health concepts that can be further categorized into two summary scores; physical and mental health. The answers from the survey is re-coded into points in where higher points indicate better perceived health. The points, ranging from 0 to 100, are then presented for the different concepts, the two summary scores and the overall score for the 36 questions.
Measured: Baseline, 6-, 12- and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start6 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two arm intervention study with allocation to usual care (Physical activity on Prescription) or usual care (Physical activity on Prescription) + an exercise intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Hult, Umeå University
- Investigators
- Andreas Hult, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658704
- Sponsor's protocol ID
- Dnr 2024-03415
- Acronym
- UMEPA
- Status last verified
- Apr 2026
- First submitted
- 18 Oct 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of individual data is not in accordance with the ethical permission granted from the Swedish ethics review authority.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Motivation Towards Exercise to Enhance Physical Activity on Prescription Adherence
- ClinicalTrials.gov ID
- NCT06658704
- Acronym / sponsor ID
- UMEPA / Dnr 2024-03415
- Conditions
- Physical Inactivity
- Keywords
- Physical Inactivity, Exercise Referral Scheme, Physical activity on Prescription, Exercise intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 26 Oct 2024 (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.
The goal of this clinical trial is to explore effectiveness on physical activity, function and psychometrics in relation to an exercise intervention in physically inactive middle-aged men and women. The main questions it aims to answer are:
- Is the exercise intervention effective in increasing physical activity, function and motivation towards exercise? Is there an intervention effect in physical activity, function and psychometrics at 6-, 12- and 24 months post baseline?
- Can barriers and facilitators towards increased physical activity be identified in the two groups of the study?
All participants will first receive standard care for physically inactive patients, i.e. Physical activity on Prescription (PaP), followed by allocation to an exercise intervention (EI) group or a control group. The EI group will be offered an additional exercise intervention for 16 weeks consisting of 1-2 training sessions per week of a combination of aerobic and resistance training at a private fitness centre. The control group will be asked to adhere to their PaP.
Researchers will assess physical activity, function and psychometrics in the two groups at 6-, 12- and 24 months to evaluate the intervention effect. Additionally, interviews with the participants in the control and EI groups will be performed in order to explore barriers and facilitators towards increased physical activity in formerly inactive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A two arm intervention study with allocation to usual care (Physical activity on Prescription) or usual care (Physical activity on Prescription) + an exercise intervention.
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Behavioral: Supervised exercise in a group setting, Behavioral: Usual care (Physical activity on Prescription)Participants are prescribed a Physical activity on Prescription (PaP) which means that they will have a motivational interview with a physiotherapist regarding increased physical activity. The physiotherapist will then prescribe a individualized PaP with the goal to increase weekly physical activity that the participant are instructed to adhere to for the remainder of the study. A follow-up session is also included after 16 weeks. Participants are invited to a 16 week exercise intervention at a private fitness center after they have received their PaP. The exercise, including a variety of aerobic and resistance training, is performed in a group setting starting with one session per week for the first two weeks and then two sessions per week for week 3-16. Follow-up tests is also included after 6-, 12- and 24 months. |
| Control | Active comparator | Behavioral: Usual care (Physical activity on Prescription)Participants are prescribed a Physical activity on Prescription (PaP) which means that they will have a motivational interview with a physiotherapist regarding increased physical activity. The physiotherapist will then prescribe a individualized PaP with the goal to increase weekly physical activity that the participant are instructed to adhere to for the remainder of the study. A follow-up session is also included after 16 weeks. Follow-up tests is also included after 6-, 12- and 24 months. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Physically inactive persons as defined as not meeting the current recommendations of at least 150 minutes of moderate to vigorous physical activity per week. This criterion is self-assessed by potential participants.
- Age 40-60 years
Key exclusion criteria (6 listed)
- Physical disability that affects the ability to perform the exercise intervention.
- Heart failure or severe degenerative disease, e.g. malignant cancer, multiple sclerosis etc.
- Myocardial infarction or stroke during the last 12 months.
- Heart conditions including angina pectoris that is worsened with exercise.
- Neuromuscular, musculoskeletal, or rheumatic conditions that is worsened with exercise.
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 |
|---|---|---|
| Supervised exercise in a group settingParticipants are invited to a 16 week exercise intervention at a private fitness center after they have received their PaP. The exercise, including a variety of aerobic and resistance training, is performed in a group setting starting with one session per week for the first two weeks and then two sessions per week for week 3-16. | Behavioural | Exercise intervention |
| Usual care (Physical activity on Prescription)Participants are prescribed a Physical activity on Prescription (PaP) which means that they will have a motivational interview with a physiotherapist regarding increased physical activity. The physiotherapist will then prescribe a individualized PaP with the goal to increase weekly physical activity that the participant are instructed to adhere to for the remainder of the study. A follow-up session is also included after 16 weeks. | Behavioural | Control, Exercise intervention |
Primary outcome
Self-reported exercise and physical activity
Time frame: Baseline, 6-, 12- and 24 months
One question regarding exercise and one question regarding every day physical activity in a typical week. The question regarding exercise comprises 6 answer alternatives ranging from 0 min to more than 120 min per week. The question regarding every day physical activity comprises 7 answer alternatives raging from 0 min to more than 300 min per week. The questions are produced by the Swedish National Board of Health and Welfare.
9 secondary outcomes
Device measured physical activity level
Time frame: Baseline, 6-, 12- and 24 months
Daily step count
Time frame: Baseline, 6-, 12- and 24 months
Cardio-respiratory capacity
Time frame: Baseline, 6-, 12- and 24 months
Upper limb strength
Time frame: Baseline, 6-, 12- and 24 months
Lower limb muscle strength
Time frame: Baseline, 6-, 12- and 24 months
Motivational stages of self-determination for exercise
Time frame: Baseline, 6-, 12- and 24 months
Confidence in one's own ability to exercise
Time frame: Baseline, 6-, 12- and 24 months
Basic psychological needs connected to physical activity satisfaction
Time frame: Baseline, 6-, 12- and 24 months
Health related quality of life
Time frame: Baseline, 6-, 12- and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. Sharing of individual data is not in accordance with the ethical permission granted from the Swedish ethics review authority.
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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.
Andreas Hult, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise in a group setting in people with Physical Inactivity, run by Umeå University at 1 site in Sweden.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Self-reported exercise and physical activity (time frame: Baseline, 6-, 12- and 24 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 1 May 2026.