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

8. september 2026 oppdatert av: University Hospital, Grenoble

Impact of Adapted Physical Activity on Persistent Fatigue in Patients With Inflammatory Bowel Disease in Remission

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic conditions that can affect patients' daily lives even when the disease is in remission. Persistent fatigue is a common and disabling symptom that may remain despite control of intestinal inflammation.

The cAPAble study will evaluate whether an adapted physical activity (APA) program can help reduce persistent fatigue in patients with IBD in remission. This is a multicenter randomized interventional study. Participants will be randomly assigned to an adapted physical activity program or usual care.

The APA program is designed to be adapted to each participant's physical abilities and needs and will be delivered over 6 months. The program aims to progressively increase physical activity and support participants in maintaining regular physical activity in their daily lives.

The main purpose of the study is to determine whether participation in the APA program improves persistent fatigue. The study will also explore potential effects on physical activity, quality of life, psychological well-being and other aspects of participants' health and daily functioning.

Participants will be followed throughout the study according to the protocol, with assessments performed at predefined time points using validated questionnaires and other study assessments. The results of the study may help improve the management of persistent fatigue in people with IBD in remission and contribute to the development of supportive non-drug approaches for these patients.

Studietype

Intervensjonell

Registrering (Antatt)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. 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.
  2. Patients with significant fatigue (FACIT-F score ≤40) persisting for at least 3 months before inclusion, confirmed by two successive FACIT-F questionnaire assessments: the first at the screening visit (M-3), after obtaining informed consent, serving as the baseline value, and the second at the inclusion visit (M0), confirming persistence of fatigue for at least 3 months.
  3. Adults aged 18 years or older.
  4. 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.

Exclusion Criteria:

  1. 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).
  2. Unstable cardiovascular or respiratory disease.
  3. Patients already meeting the WHO physical activity recommendations before inclusion (IPAQ score ≥1500).
  4. Current pregnancy or pregnancy planned during the study period.
  5. Inability, for technical or other reasons, to connect to the Internet for telemonitoring and/or telerehabilitation.
  6. Planned surgery requiring hospitalization.
  7. Refusal to participate.
  8. Persons under legal guardianship or deprived of liberty.
  9. Uncontrolled diagnosed psychiatric disorder.
  10. Participant currently in an exclusion period for another clinical study.
  11. Participant who cannot be contacted in case of an emergency.
  12. Any surgery planned during the first 6 months of the study that requires hospitalization.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Adapted Physical Activity
A 6-month adapted physical activity program tailored to the participant's individual physical abilities and needs.
Atferdsmessig: Adapted Physical Activity
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.
Annen: Usual Care
Participants will receive usual care according to standard clinical practice.
Annen: Usual Care
Participants will receive usual care according to standard clinical practice.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at 6 months.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fatigue assessed by the FACIT-Fatigue (FACIT-F) score at 3 and 12 months
Tidsramme: At 3 months and 12 months
The FACIT-Fatigue subscale is a 13-item self-administered questionnaire. The total score ranges from 0 to 52; a higher score indicates less fatigue (better outcome). Mean scores are compared between the adapted physical activity arm and the standard care arm.
At 3 months and 12 months
Physical condition assessed by Body weight
Tidsramme: At 6 months and 12 months
Body weight (kg) - mean values are compared between the adapted physical activity arm and the standard care arm.
At 6 months and 12 months
Physical condition assessed by body mass index
Tidsramme: At 6 months and 12 months
Body mass index (kg/m²) - Mean values are compared between the adapted physical activity arm and the standard care arm.
At 6 months and 12 months
Physical condition assessed by waist circumference
Tidsramme: At 6 months and 12 months
Waist circumference (cm) - Mean values are compared between the adapted physical activity arm and the standard care arm.
At 6 months and 12 months
Physical condition assessed by handgrip strength
Tidsramme: At 6 months and 12 months
Handgrip strength measured by dynamometer (kg) - Mean values are compared between the adapted physical activity arm and the standard care arm.
At 6 months and 12 months
Health care resource use
Tidsramme: At 6 months and 12 months
Number of participants with at least one of the following events, collected using a study-specific health care use questionnaire: hospitalisation, corticosteroid course, change in inflammatory bowel disease therapy, consultation with a general practitioner, consultation with a psychologist, and use of complementary or alternative medicine. Compared between the adapted physical activity arm and the standard care arm.
At 6 months and 12 months
Health care resource use
Tidsramme: At 6 months and 12 months
Proportion of participants with at least one of the following events, collected using a study-specific health care use questionnaire: hospitalisation, corticosteroid course, change in inflammatory bowel disease therapy, consultation with a general practitioner, consultation with a psychologist, and use of complementary or alternative medicine. Compared between the adapted physical activity arm and the standard care arm.
At 6 months and 12 months
Biological disease activity assessed by C-reactive protein (mg/L)
Tidsramme: At 3 months, 6 months and 12 months
C-reactive protein (mg/L) - a higher value indicates greater disease activity. Mean values are compared between the adapted physical activity arm and the standard care arm.
At 3 months, 6 months and 12 months
Biological disease activity assessed by Faecal calprotectin (µg/g)
Tidsramme: At 3 months, 6 months and 12 months
Faecal calprotectin (µg/g) - a higher value indicates greater disease activity. Mean values are compared between the adapted physical activity arm and the standard care arm.
At 3 months, 6 months and 12 months
Physical activity level assessed by the International Physical Activity Questionnaire (IPAQ)
Tidsramme: At 3 months, 6 months and 12
The International Physical Activity Questionnaire (IPAQ) is a self-administered questionnaire; physical activity is expressed in MET-minutes per week. A higher value indicates a higher level of physical activity. Mean values are compared between the adapted physical activity arm and the standard care arm.
At 3 months, 6 months and 12
Functional capacity assessed by the 6-minute walk test
Tidsramme: At 6 months and 12 months
Maximal distance walked during the 6-minute walk test, expressed in metres. A greater distance indicates better functional capacity. Mean values are compared between the adapted physical activity arm and the standard care arm.
At 6 months and 12 months
Correlation between a fatigue visual analogue scale and the FACIT-Fatigue score
Tidsramme: At 3 months, 6 months and 12 months
Correlation coefficient between the fatigue visual analogue scale (VAS-F, scored from 0 to 10, a higher score indicating more fatigue) and the FACIT-Fatigue score (scored from 0 to 52, a higher score indicating less fatigue), at each assessment time point. This outcome measure is assessed in the whole study population and is not a between-arm comparison.
At 3 months, 6 months and 12 months
Quality of life assessed by the Inflammatory Bowel Disease Disability Index (IBD-Disk)
Tidsramme: At 3 months, 6 months and 12 months
The Inflammatory Bowel Disease Disability Index (IBD-Disk) is a 10-item self-administered instrument. Each item is rated on a numerical scale from 0 to 10, resulting in a total score ranging from 0 to 100. Higher scores indicate greater disability and poorer quality of life. Mean IBD-Disk scores will be compared between the adapted physical activity arm and the standard care arm.
At 3 months, 6 months and 12 months
State anxiety assessed by the State-Trait Anxiety Inventory - State subscale (STAI-State)
Tidsramme: At 6 months and 12 months
The State-Trait Anxiety Inventory - State subscale (STAI-State) is a 20-item self-administered instrument assessing current state anxiety. The total score ranges from 20 to 80, with higher scores indicating greater state anxiety. Mean STAI-State scores will be compared between the adapted physical activity arm and the standard care arm.
At 6 months and 12 months
Depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: At 6 months and 12 months
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-administered instrument assessing depressive symptoms. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. Mean PHQ-9 scores will be compared between the adapted physical activity arm and the standard care arm.
At 6 months and 12 months
Clinical disease activity assessed by the Patient-Reported Outcomes 2 (PRO2)
Tidsramme: At 3 months, 6 months and 12 months
The Patient-Reported Outcomes 2 (PRO2) is a patient-reported measure of ulcerative colitis disease activity based on stool frequency and rectal bleeding. The total score ranges from 0 to 6, with higher scores indicating greater clinical disease activity. Mean PRO2 scores will be compared between the adapted physical activity arm and the standard care arm.
At 3 months, 6 months and 12 months

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Sponsor

University Hospital, Grenoble

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2027

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. februar 2030

Datoer for studieregistrering

Først innsendt

31. august 2026

Først innsendt som oppfylte QC-kriteriene

31. august 2026

Først lagt ut (Faktiske)

4. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 38RC24.0272

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