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

NCT ID: NCT05691803

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-03
• Study Completion Date: 2023-09-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise intervention

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.

Group Type: EXPERIMENTAL

Exercise intervention

Intervention Type: 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.

Interventions

Exercise intervention

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Andreas Hult

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Umeå University

Umeå, Västerbotten County, Sweden

Countries

Sweden

Other Identifiers

UMEPA01

Identifier Type: -

Identifier Source: org_study_id