Understanding Motivation Towards Exercise to Enhance Physical Activity on Prescription Adherence - Feasibility Study

NCT05691803 | Completed

• 1 other identifier: UMEPA01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Inactivity

Keywords

Physical inactivity; Exercise Referral Scheme; Physical activity on Prescription; Exercise intervention; Feasibility study

Outcome Measures

Primary Outcomes (2)

• Adherence to the exercise intervention

  Number of completed training sessions in the exercise intervention group

  Documented continuously during the 12 week intervention period

• Retention rate

  The proportion of participants starting the intervention that completes outcome assessment in either group

  3 months post baseline

Secondary Outcomes (10)

• Time spent in moderate and vigorous physical activity

  Baseline, 3 months and 6 months

• Daily step-count

  Baseline, 3 months and 6 months

• Cardio-respiratory capacity

  Baseline, 3 months and 6 months

• Upper limb strength

  Baseline, 3 months and 6 months

• Lower limb muscle strength

  Baseline, 3 months and 6 months

Other Outcomes (2)

• Feasibility of the exercise intervention

  3 months

• Exploring barriers and facilitators towards physical activity

  6 months

Study Arms (1)

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.

Behavioral: Exercise intervention

Interventions

Exercise intervention BEHAVIORAL

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.

Exercise intervention

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Umeå University

Umeå, Västerbotten County, SE-90187, Sweden

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A one arm intervention study with allocation to usual care (Physical activty on Prescription) + an exercise intervention.

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 20, 2023
• Study Start: February 3, 2023
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: April 2, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)