Clinical trial NCT06106607: Physical Activity and Sedentary Behaviour in Patients With Inflammatory Bowel Disease
Official title: Physical Activity and Sedentary Behaviour in Patients With Inflammatory Bowel Disease - Epidemiology and Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Physical Activity
Sedentary Behavior
Feasibility Study
Lead sponsor: Center for Clinical Research and Prevention
Sponsor class: NETWORK
Collaborators: name: Bispebjerg Hospital
First posted: 2023-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Recruitment
timeFrame: Assessed at 3 months after baseline
measure: Retention
timeFrame: Assessed at 5 months (20 weeks)
measure: Intervention adherence
timeFrame: Assessed at 5 months (20 weeks)
measure: Intervention acceptability
timeFrame: Assessed at 5 months (20 weeks)
Secondary outcomes:
measure: Objectively measured physical activity measured by SENS monitor
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Self-reported physical activity and sitting time measured by the Physical Activity Scale (PAS)
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Exercise self-efficacy measured by the Exercise Self-Efficacy Scale
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Health-related quality of life measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Fatigue measured by The Multi-dimensional Fatigue Inventory (MFI-20)
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Fatigue measured by the visual analogue scale for fatigue (VAS-Fatigue)
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Pain intensity measured by the visual analogue scale for pain (VAS-Pain)
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Mental health measured by The Hospital Anxiety and Depression Scale (HADS) questionnaire
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: IBD-related disease activity measured by fecal calprotectin
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Serum lipids measured by blood sample
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Glycosylated hemoglobin (HbA1c) measured by blood sample
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Disease activity measured by a C-Reactive Protein (CRP) test
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Blood pressure measurements
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Body weight in kilograms
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Waist circumference measured in centimeters
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Hip circumference measured in centimeters
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Waist-hip-ratio
timeFrame: Assessed at baseline and at 5 months (20 weeks)
measure: Body mass Index (BMI)
timeFrame: Assessed at baseline and at 5 months (20 weeks)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Digestive Disease Center, BFH
Study officials:
affiliation: Professor at Center for Clinical Research and Prevention
name: Mette Aadahl, PhD
role: PRINCIPAL_INVESTIGATOR
References: