Physical Activity and Sedentary Behaviour in Patients With Inflammatory Bowel Disease

NCT06106607 | Completed DMC

• 1 other identifier: H-22040390
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Recruitment

  Recruitment rates will be calculated as the proportion of patients randomised/proportion of patients eligible

  Assessed at 3 months after baseline

• Retention

  Retention rates will be calculated as the proportion of patients providing the outcomes of interest/proportion of patients randomised

  Assessed at 5 months (20 weeks)

• Intervention adherence

  Adherence to intervention protocol will be calculated as the number of group and motivational counselling sessions attended out of the total number of sessions available

  Assessed at 5 months (20 weeks)

• Intervention acceptability

  Acceptability of intervention protocol will be calculated as the number of received optional elements of the intervention out of the total number of optional intervention elements available

  Assessed at 5 months (20 weeks)

Secondary Outcomes (18)

• Objectively measured physical activity measured by SENS monitor

  Assessed at baseline and at 5 months (20 weeks)

• Self-reported physical activity and sitting time measured by the Physical Activity Scale (PAS)

  Assessed at baseline and at 5 months (20 weeks)

• Exercise self-efficacy measured by the Exercise Self-Efficacy Scale

  Assessed at baseline and at 5 months (20 weeks)

• Health-related quality of life measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)

  Assessed at baseline and at 5 months (20 weeks)

• Fatigue measured by The Multi-dimensional Fatigue Inventory (MFI-20)

  Assessed at baseline and at 5 months (20 weeks)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Intervention group

Control group

NO INTERVENTION

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

Interventions

Intervention group 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center for Clinical Research and Prevention: lead
• Bispebjerg Hospital: collaborator

Study Sites (1)

Digestive Disease Center, BFH

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Behavior

Study Officials

• Mette Aadahl, PhD

  Professor at Center for Clinical Research and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Allocation status of study participants will not be revealed for the project nurses that conduct the outcome assessments
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: November 15, 2023
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)