Clinical trial NCT06658704: Understanding Motivation Towards Exercise to Enhance Physical Activity on Prescription Adherence
Official title: Understanding Motivation Towards Exercise to Enhance Physical Activity on Prescription Adherence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Physical Inactivity
Keywords: Physical Inactivity
Exercise Referral Scheme
Physical activity on Prescription
Exercise intervention
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.


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: Self-reported exercise and physical activity
timeFrame: Baseline, 6-, 12- and 24 months
Secondary outcomes:
measure: Device measured physical activity level
timeFrame: Baseline, 6-, 12- and 24 months
measure: Daily step count
timeFrame: Baseline, 6-, 12- and 24 months
measure: Cardio-respiratory capacity
timeFrame: Baseline, 6-, 12- and 24 months
measure: Upper limb strength
timeFrame: Baseline, 6-, 12- and 24 months
measure: Lower limb muscle strength
timeFrame: Baseline, 6-, 12- and 24 months
measure: Motivational stages of self-determination for exercise
timeFrame: Baseline, 6-, 12- and 24 months
measure: Confidence in one's own ability to exercise
timeFrame: Baseline, 6-, 12- and 24 months
measure: Basic psychological needs connected to physical activity satisfaction
timeFrame: Baseline, 6-, 12- and 24 months
measure: Health related quality of life
timeFrame: Baseline, 6-, 12- and 24 months
Other outcomes:
measure: Exploring barriers and facilitators towards physical activity
timeFrame: 12- and/or 24 months
Locations:
city: Umeå
country: Sweden
facility: Umeå University
state: Västerbotten
Study officials:
affiliation: Umeå University
name: Andreas Hult, PhD
role: PRINCIPAL_INVESTIGATOR
References: