Physical InactivityUMEPA-FNCT05691803
Understanding Motivation Towards Exercise to Enhance Physical Activity on Prescription Adherence - Feasibility Study
A study testing Exercise intervention 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 feasibility and evaluate methods to investigate changes in 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?
- Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 3 Feb 2023to 29 Sep 2023
- 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 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 feasibility and evaluate methods to investigate changes in 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 feasible regarding retention and user experience?
- Is the evaluation methods on physical activity, function and psychometrics suitable for the present study?
- Is there an intervention effect in physical activity, function and psychometrics at three and six month 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. The EI group will be offered an additional exercise intervention for 12 weeks consisting of 1-2 training sessions per week of a combination of aerobic and resistance training at a private fitness center.
Feasibility of the exercise intervention will be evaluated based on retention rates and user experience.
Additionally, researchers will assess physical activity, function and psychometrics in the EI group at three and six months to evaluate the suitability of the chosen methods and to get preliminary data on the intervention effect. Finally, interviews with the participants in the control and EI groups will be performed at the end of the study in order to explore barriers and facilitators towards increased physical activity in formally inactive patients.
Edit after registration of the study: Due to a lower number of recruited participants than expected (20 instead of the anticipated 30), the protocol was updated by removing the control group that would initially consist of 10 participants. The remaining 20 participants were all allocated to the exercise intervention group to assess feasibility of the intervention.
- Conditions
- Physical Inactivity
- Being tested
- Exercise intervention
- Keywords
- Physical inactivity, Exercise Referral Scheme, Physical activity on Prescription, Exercise intervention, Feasibility study
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
The 6 month intervention consists of usual care (PaP) plus an initial 12 weeks of instructor led exercise (described below) followed by a 12 week period in where the participant will have to conduct their physical activity on their own.
Exercise intervention:
Participants are invited to a 12 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 three weeks and then two sessions per week for week 4-12. A follow-up session is also included after 12 weeks in where a physiotherapist contact the participant and discuss how they will adhere to their Physical activity on prescription.
| 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 12 weeks.
Participants are invited to a 12 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 three weeks and then two sessions per week for week 4-12. A follow-up session is also included after 12 weeks. Receives: Behavioral: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the exercise intervention
Number of completed training sessions in the exercise intervention group
Measured: Documented continuously during the 12 week intervention period
Retention rate
The proportion of participants starting the intervention that completes outcome assessment in either group
Measured: 3 months post baseline
Secondary outcomes (10)
Time spent in moderate and vigorous physical activity
Objectively measured physical activity, measured with an accelerometer for 7 consecutive days. Raw data are then recalculated to minutes spent in different intensity zones and finally minutes in moderate and vigorous physical activity are calculated.
Measured: Baseline, 3 months and 6 months
Daily step-count
Objectively measured physical activity, measured with an accelerometer for 7 consecutive days is used to collect step-count which is presented as steps taken per day.
Measured: Baseline, 3 months and 6 months
Cardio-respiratory capacity
Ekblom-Bak cycle ergometer test will be used to assess cardio-respiratory fitness.
Measured: Baseline, 3 months and 6 months
Upper limb strength
Hand grip strength om 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, 3 months and 6 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, 3 months and 6 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, 3 months and 6 months
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, 3 months and 6 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, 3 months and 6 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, 3 months and 6 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: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start3 Feb 2023
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
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
- Not applicable
- Intervention model
- Single group
- Model description
- A one arm intervention study with allocation to usual care (Physical activty on Prescription) + an exercise intervention.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Hult, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691803
- Sponsor's protocol ID
- UMEPA01
- Acronym
- UMEPA-F
- Status last verified
- May 2023
- First submitted
- 21 Dec 2022
- Last updated
- 2 Apr 2025
- 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 2 Apr 2025. 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 - Feasibility Study
- ClinicalTrials.gov ID
- NCT05691803
- Acronym / sponsor ID
- UMEPA-F / UMEPA01
- Conditions
- Physical Inactivity
- Keywords
- Physical inactivity, Exercise Referral Scheme, Physical activity on Prescription, Exercise intervention, Feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 20 Jan 2023 (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 feasibility and evaluate methods to investigate changes in 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 feasible regarding retention and user experience?
- Is the evaluation methods on physical activity, function and psychometrics suitable for the present study?
- Is there an intervention effect in physical activity, function and psychometrics at three and six month 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. The EI group will be offered an additional exercise intervention for 12 weeks consisting of 1-2 training sessions per week of a combination of aerobic and resistance training at a private fitness center.
Feasibility of the exercise intervention will be evaluated based on retention rates and user experience.
Additionally, researchers will assess physical activity, function and psychometrics in the EI group at three and six months to evaluate the suitability of the chosen methods and to get preliminary data on the intervention effect. Finally, interviews with the participants in the control and EI groups will be performed at the end of the study in order to explore barriers and facilitators towards increased physical activity in formally inactive patients.
Edit after registration of the study: Due to a lower number of recruited participants than expected (20 instead of the anticipated 30), the protocol was updated by removing the control group that would initially consist of 10 participants. The remaining 20 participants were all allocated to the exercise intervention group to assess feasibility of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A one arm intervention study with allocation to usual care (Physical activty on Prescription) + an exercise intervention.
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Behavioral: Exercise interventionParticipants 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 12 weeks. Participants are invited to a 12 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 three weeks and then two sessions per week for week 4-12. A follow-up session is also included after 12 weeks. |
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 |
|---|---|---|
| Exercise interventionThe 6 month intervention consists of usual care (PaP) plus an initial 12 weeks of instructor led exercise (described below) followed by a 12 week period in where the participant will have to conduct their physical activity on their own. Exercise intervention: Participants are invited to a 12 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 three weeks and then two sessions per week for week 4-12. A follow-up session is also included after 12 weeks in where a physiotherapist contact the participant and discuss how they will adhere to their Physical activity on prescription. | Behavioural | Exercise intervention |
Primary outcome
Adherence to the exercise intervention
Time frame: Documented continuously during the 12 week intervention period
Number of completed training sessions in the exercise intervention group
Retention rate
Time frame: 3 months post baseline
The proportion of participants starting the intervention that completes outcome assessment in either group
10 secondary outcomes
Time spent in moderate and vigorous physical activity
Time frame: Baseline, 3 months and 6 months
Daily step-count
Time frame: Baseline, 3 months and 6 months
Cardio-respiratory capacity
Time frame: Baseline, 3 months and 6 months
Upper limb strength
Time frame: Baseline, 3 months and 6 months
Lower limb muscle strength
Time frame: Baseline, 3 months and 6 months
Health related quality of life
Time frame: Baseline, 3 months and 6 months
Self-reported exercise and physical activity
Time frame: Baseline, 3 months and 6 months
Motivational stages of self-determination for exercise
Time frame: Baseline, 3 months and 6 months
Confidence in one's own ability to exercise
Time frame: Baseline, 3 months and 6 months
Basic psychological needs connected to physical activity satisfaction
Time frame: 3 months and 6 months
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 2 Apr 2025.
- Individual participant dataSharing planned: No. Sharing of individual data is not in accordance with the ethical permission granted from the Swedish ethics review authority.
Related trials for Physical Inactivity
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
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.
The record lists no contact. Use the official record to reach the sponsor.
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 intervention 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: finished, as of the sponsor's last update on 2 Apr 2025. 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?
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?
Adherence to the exercise intervention (time frame: Documented continuously during the 12 week intervention period). 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 2 Apr 2025.