Adapted Physical Activity for Persistent Fatigue in Patients With Inflammatory Bowel Disease in Remission (cAPAble)
2026年9月8日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Clémence LOMBOIS, Dr
- 電話番号：04767673749
- メール：CLombois@chu-grenoble.fr
研究場所
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Grenoble、フランス、38700
- CHU Grenoble Alpes
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コンタクト：
- Anna BOROWIK
- 電話番号：0476769314
- メール：ABorowik@chu-grenoble.fr
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コンタクト：
- Mbene FALL
- 電話番号：0695038784
- メール：mfall2@chu-grenoble.fr
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
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.
- 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.
- 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.
Exclusion Criteria:
- 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.
- Patients already meeting the WHO physical activity recommendations before inclusion (IPAQ score ≥1500).
- 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 currently in an exclusion period for another clinical study.
- Participant who cannot be contacted in case of an emergency.
- Any surgery planned during the first 6 months of the study that requires hospitalization.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Adapted Physical Activity
A 6-month adapted physical activity program tailored to the participant's individual physical abilities and needs.
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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.
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他の：Usual Care
Participants will receive usual care according to standard clinical practice.
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Participants will receive usual care according to standard clinical practice.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at 6 months.
時間枠：at 6 months
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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.
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at 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Fatigue assessed by the FACIT-Fatigue (FACIT-F) score at 3 and 12 months
時間枠：At 3 months and 12 months
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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.
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At 3 months and 12 months
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Physical condition assessed by Body weight
時間枠：At 6 months and 12 months
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Body weight (kg) - mean values are compared between the adapted physical activity arm and the standard care arm.
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At 6 months and 12 months
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Physical condition assessed by body mass index
時間枠：At 6 months and 12 months
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Body mass index (kg/m²) - Mean values are compared between the adapted physical activity arm and the standard care arm.
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At 6 months and 12 months
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Physical condition assessed by waist circumference
時間枠：At 6 months and 12 months
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Waist circumference (cm) - Mean values are compared between the adapted physical activity arm and the standard care arm.
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At 6 months and 12 months
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Physical condition assessed by handgrip strength
時間枠：At 6 months and 12 months
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Handgrip strength measured by dynamometer (kg) - Mean values are compared between the adapted physical activity arm and the standard care arm.
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At 6 months and 12 months
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Health care resource use
時間枠：At 6 months and 12 months
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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.
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At 6 months and 12 months
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Health care resource use
時間枠：At 6 months and 12 months
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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.
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At 6 months and 12 months
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Biological disease activity assessed by C-reactive protein (mg/L)
時間枠：At 3 months, 6 months and 12 months
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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.
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At 3 months, 6 months and 12 months
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Biological disease activity assessed by Faecal calprotectin (µg/g)
時間枠：At 3 months, 6 months and 12 months
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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.
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At 3 months, 6 months and 12 months
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Physical activity level assessed by the International Physical Activity Questionnaire (IPAQ)
時間枠：At 3 months, 6 months and 12
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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.
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At 3 months, 6 months and 12
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Functional capacity assessed by the 6-minute walk test
時間枠：At 6 months and 12 months
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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.
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At 6 months and 12 months
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Correlation between a fatigue visual analogue scale and the FACIT-Fatigue score
時間枠：At 3 months, 6 months and 12 months
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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.
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At 3 months, 6 months and 12 months
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Quality of life assessed by the Inflammatory Bowel Disease Disability Index (IBD-Disk)
時間枠：At 3 months, 6 months and 12 months
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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.
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At 3 months, 6 months and 12 months
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State anxiety assessed by the State-Trait Anxiety Inventory - State subscale (STAI-State)
時間枠：At 6 months and 12 months
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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.
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At 6 months and 12 months
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Depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9)
時間枠：At 6 months and 12 months
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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.
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At 6 months and 12 months
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Clinical disease activity assessed by the Patient-Reported Outcomes 2 (PRO2)
時間枠：At 3 months, 6 months and 12 months
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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.
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At 3 months, 6 months and 12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年6月1日
一次修了 (推定)
2028年12月1日
研究の完了 (推定)
2030年2月1日
試験登録日
最初に提出
2026年8月31日
QC基準を満たした最初の提出物
2026年8月31日
最初の投稿 (実際)
2026年9月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月11日
QC基準を満たした最後の更新が送信されました
2026年9月8日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。