Clinical trial NCT05691803: Understanding Motivation Towards Exercise to Enhance Physical Activity on Prescription Adherence - Feasibility Study
Official title: Understanding Motivation Towards Exercise to Enhance Physical Activity on Prescription Adherence - Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Keywords: Physical inactivity
Exercise Referral Scheme
Physical activity on Prescription
Exercise intervention
Feasibility study
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A one arm intervention study with allocation to usual care (Physical activty on Prescription) + an exercise intervention.
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Adherence to the exercise intervention
timeFrame: Documented continuously during the 12 week intervention period
measure: Retention rate
timeFrame: 3 months post baseline
Secondary outcomes:
measure: Time spent in moderate and vigorous physical activity
timeFrame: Baseline, 3 months and 6 months
measure: Daily step-count
timeFrame: Baseline, 3 months and 6 months
measure: Cardio-respiratory capacity
timeFrame: Baseline, 3 months and 6 months
measure: Upper limb strength
timeFrame: Baseline, 3 months and 6 months
measure: Lower limb muscle strength
timeFrame: Baseline, 3 months and 6 months
measure: Health related quality of life
timeFrame: Baseline, 3 months and 6 months
measure: Self-reported exercise and physical activity
timeFrame: Baseline, 3 months and 6 months
measure: Motivational stages of self-determination for exercise
timeFrame: Baseline, 3 months and 6 months
measure: Confidence in one's own ability to exercise
timeFrame: Baseline, 3 months and 6 months
measure: Basic psychological needs connected to physical activity satisfaction
timeFrame: 3 months and 6 months
Other outcomes:
measure: Feasibility of the exercise intervention
timeFrame: 3 months
measure: Exploring barriers and facilitators towards physical activity
timeFrame: 6 months
Locations:
city: Umeå
country: Sweden
facility: Umeå University
state: Västerbotten
Study officials:
References: