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

NCT05691803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-02

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Umeå University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2023-09-29
Completion
2023-09-29

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05691803 on ClinicalTrials.gov