Physical Activity and Sedentary Behaviour in Patients With Inflammatory Bowel Disease

NCT ID: NCT06106607

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2024-09-03

Brief Summary

Emerging research suggests that physical activity may improve health-related quality of life (HrQoL) in patients with inflammatory bowel disease (IBD) and positively influence physical symptoms, fatigue, stress and anxiety. However, little is known about detailed movement patterns and their specific health effects in IBD patients or about patients' wishes, motivation and preferences for physical activity in their everyday lives.

Based on exisiting evidence, the investigators' hypothesis is that an individually tailored, behavioural intervention focusing on reducing sedentary behaviour and increasing daily physical activity is feasible and effective in patients with IBD. Therefore, the overall aim of this randomized feasibility study is to determine the feasibility of the behavioural intervention, including the testing of recruitment procedures, intervention adherence, retention and outcome assessments.

Intervention participants will undergo:

1. A group session with information about IBD and the effects and recommendations of physical activity and exercise

2. Four motivational interviews with a project nurse, including goal-setting and action plans

3. An optional part, where each participant will have the possibility of choosing between:

• An one-hour individual session with a physiotherapist
• Being teamed up with 1-2 'exercise buddies' (other intervention participants) and/or
• Access to four short 2-3 minutes videos/'reels' of a physiotherapist explaining and demonstrating beneficial physical exercises

Results from the present feasibility study will determine if and how to proceed with a large-scale randomized controlled trial evaluating the efficacy of the intervention.

Detailed Description

Although existing literature indicates potential health benefits of physical activity and exercise in patients with IBD, there is little consistency in the proposed interventions for promoting physical activity, and large variations in the applied physical activity intensities and types in the existing physical activity intervention studies. Patients with IBD experience barriers to engaging in physical activity that are related to both stigmatization and disease symptoms. These are barriers that might be overcome if the physical intervention is focusing on variation in physical activity intensity and is tailored to the individual patient. The investigators' hypothesis is that an individually tailored, behavioural intervention focusing on physical activity in a 24-hour perspective, including sedentary behaviour and physical activity from light to vigorous intensity, is feasible and effective in patients with IBD.

The present feasibility study aims to test the behavioural intervention for feasibility and acceptability in a small sample (N=30) of patients with IBD from the gastroenterology outpatient clinic at Bispebjerg Hospital, Copenhagen, Denmark. By conducting a feasibility study with a small sample size, the investigators want to follow the course and applicability of an intervention that has been developed as an individual offer with possibilities and solutions for the individual patient, but still operated within a controlled and standardized research frame. Assessment of feasibility will include identification of barriers for recruitment, acceptance of group/randomization status, delivery methods, retention, outcome assessments and logistics. Outcome measures that will be tested for feasibility include objectively measured physical activity levels (over a 7-day period), health-related quality of life, fatigue, pain, mental health and cardio-metabolic biomarkers.

The intervention will address the individual patient's knowledge, motivation, resources and opportunities for reducing sedentary behaviour and increasing daily physical activity and exercise in the individual's everyday life.

The 20-week intervention will consist of a basic part for all participants, which will include

1. A group session with education about IBD in general and about physical activity and exercise in relation to IBD (definitions, evidence and recommendations). Following this session, the participants will also be offered access to a video with general information about IBD, physical activity and exercise

2. Four individual motivational counselling sessions (two physical and two telephone sessions) with a project nurse. The counselling sessions will involve identifying the individual's motivation and opportunities for increasing physical activity, behavioral goal setting and action planning.

An optional intervention part will then follow, where the individual participant will have the possibility of choosing between (or all of)

1. A one-hour individual session with a physiotherapist from Bispebjerg/Frederiksberg Hospitals, which will involve guidance in physical activity and exercise tailored to the individual participant. This could be the case if a participant experiences specific symptoms or limitations when engaging in physical activity and/or exercise and needs individual guidance related to this.

2. Being teamed up with 1-2 'exercise buddies' (other participants from the overall intervention group).

3. Access to 4 short 2-3 minutes videos/'reels' of a physiotherapist explaining and demonstrating beneficial physical exercises. The videos aim to provide participants with new inspiration and practical suggestions to increase their physical activity and exercise.

The main setting of the intervention will be the participants' everyday lives (family, work/school, leisure-time activities). However, the Gastroenterology Department, Bispebjerg Hospital, and potentially, local municipal health centres and sports clubs will be the actual physical places for the specific intervention elements (e.g. education, counselling sessions, physiotherapist-led sessions, exercising in small communities ('exercise buddies').

Participants randomized to the control group will be encouraged to maintain their usual lifestyle and activities. They will be expected to undergo the same baseline - and outcome assessment as the participants in the intervention group.

Results from the present feasibility study will determine if and how to proceed with a large-scale randomized controlled trial evaluating the efficacy of the intervention.

Conditions

Inflammatory Bowel Diseases; Physical Activity; Sedentary Behavior; Feasibility Study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention group

This group will undergo a 20-week individually tailored, behavioral intervention

Group Type: EXPERIMENTAL

Intervention group

Intervention Type: BEHAVIORAL

A 20-week intervention with a basic part, including

1. A group session with education about IBD,physical activity and exercise in relation to IBD (definitions, evidence and recommendations). Furthermore, access to a video with general information about IBD, physical activity and exercise

2. Four individual motivational counselling sessions (two physical, two by telephone) with a project nurse. These will involve identifying individual motivation and opportunities for increasing physical activity and behavioral goal setting.

An optional intervention part will follow, including choises between (or all of)

1. A one-hour individual session with a physiotherapist, involving guidance in physical activity and exercise tailored to the individual.

2. Being teamed up with 1-2 'exercise buddies' (other participants from the overall intervention group).

3. Access to 4 short 2-3 minutes videos/'reels' of a physiotherapist explaining and demonstrating beneficial physical exercises.

Control group

This group will be encouraged to maintain usual lifestyle and activities.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention group

A 20-week intervention with a basic part, including

1. A group session with education about IBD,physical activity and exercise in relation to IBD (definitions, evidence and recommendations). Furthermore, access to a video with general information about IBD, physical activity and exercise

2. Four individual motivational counselling sessions (two physical, two by telephone) with a project nurse. These will involve identifying individual motivation and opportunities for increasing physical activity and behavioral goal setting.

An optional intervention part will follow, including choises between (or all of)

1. A one-hour individual session with a physiotherapist, involving guidance in physical activity and exercise tailored to the individual.

2. Being teamed up with 1-2 'exercise buddies' (other participants from the overall intervention group).

3. Access to 4 short 2-3 minutes videos/'reels' of a physiotherapist explaining and demonstrating beneficial physical exercises.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• A diagnosis of IBD (Crohn's disease or ulcerative colitis) > 1 year
• Over 18 years of age
• Minimum three months stable medication type and dose without use of steroids as part of the medical treatment during the last three months
• Speak and understand Danish

Exclusion Criteria

• Unable to give informed consent
• Active inflammatory disease in joints, skin, pancreas, thyroid, lungs or liver that can hinder engagement in physical activity and exercise
• Cognitive and/or mental disabilities that can hinder engagement in physical activity and exercise
• Engaging in high-intensity physical activity -/> 8 hours pr week

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: collaborator

Center for Clinical Research and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Tanja Thomsen

Postdoc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mette Aadahl, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor at Center for Clinical Research and Prevention

Locations

Digestive Disease Center, BFH

Copenhagen, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H-22040390

Identifier Type: -

Identifier Source: org_study_id