Adapted Physical Activity for Persistent Fatigue in Patients With Inflammatory Bowel Disease in Remission

NCT07804511 | Not Yet Recruiting

• 1 other identifier: 38RC24.0272
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The cAPAble study aims to evaluate the impact of an adapted physical activity program on persistent fatigue in patients with inflammatory bowel disease in remission. This multicenter randomized study will include 120 participants. Participants will be randomly assigned to either a 6-month adapted physical activity program or usual care. Fatigue will be assessed using the FACIT-F questionnaire at 6 months.

Conditions

Inflammatory Bowel Diseases (IBD); Fatigue; Crohn Disease (CD); Ulcerative Colitis (UC)

Keywords

Inflammatory bowel disease; Persistent fatigue; Adapted physical activity; Disease remission

Outcome Measures

Primary Outcomes (1)

• Mean Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at 6 months.

  Mean Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score in each study arm at 6 months. The FACIT-F scale ranges from 0 to 52, with higher scores indicating less fatigue and better quality of life.

  at 6 months

Secondary Outcomes (16)

• Fatigue assessed by the FACIT-Fatigue (FACIT-F) score at 3 and 12 months

  At 3 months and 12 months

• Quality of life assessed by the Inflammatory Bowel Disease Disability Index (IBD-Disk)

  At 3 months, 6 months and 12 months

• Physical condition assessed by Body weight

  At 6 months and 12 months

• Physical condition assessed by body mass index

  At 6 months and 12 months

• Physical condition assessed by waist circumference

  At 6 months and 12 months

Study Arms (2)

Adapted Physical Activity

EXPERIMENTAL

A 6-month adapted physical activity program tailored to the participant's individual physical abilities and needs.

Behavioral: Adapted Physical Activity

Usual Care

OTHER

Participants will receive usual care according to standard clinical practice.

Other: Usual Care

Interventions

Adapted Physical Activity BEHAVIORAL

A 6-month adapted physical activity program tailored to each participant's physical abilities and individual needs. The program consists of 12 one-hour sessions delivered every two weeks, followed by 2 months of telephone follow-up to support participants in maintaining regular physical activity.

Adapted Physical Activity

Usual Care OTHER

Participants will receive usual care according to standard clinical practice.

Usual Care

Eligibility Criteria

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

You may qualify if:

• Patients with inflammatory bowel disease (IBD) in clinical and biological remission (CRP/fecal calprotectin) for more than 6 months:
• Remission according to PRO2 (Patient-Reported Outcome): liquid stool frequency ≤2/day and abdominal pain score ≤1 for Crohn's disease; stool frequency score ≤1 and rectal bleeding score = 0 for ulcerative colitis.
• CRP \<5 mg/L.
• Fecal calprotectin \<250 µg/g.
• Adults aged 18 years or older.
• Medical certificate confirming fitness to participate in physical activity. If the participant does not have a recent certificate dated within the previous 3 months, a specific consultation with the treating physician will be required. This consultation will be covered by the sponsor.

You may not qualify if:

• Another identified cause of fatigue based on the first-line assessment performed in this context (complete blood count, liver function tests, CRP, blood electrolyte panel, serum creatinine, iron studies, folate, vitamin B12, TSH, fasting blood glucose).
• Unstable cardiovascular or respiratory disease.
• Current pregnancy or pregnancy planned during the study period.
• Inability, for technical or other reasons, to connect to the Internet for telemonitoring and/or telerehabilitation.
• Planned surgery requiring hospitalization.
• Refusal to participate.
• Persons under legal guardianship or deprived of liberty.
• Uncontrolled diagnosed psychiatric disorder.
• Participant who cannot be contacted in case of an emergency.
• Any surgery planned during the first 6 months of the study that requires hospitalization.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38700, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Fatigue; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colitis; Colonic Diseases

Central Study Contacts

Clémence LOMBOIS, Dr

CONTACT

04767673749; CLombois@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): February 1, 2030
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)