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治験 NCT05664178（対象：消化器癌）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05664178 は 消化器癌 に関する 支持療法 の研究で、第I相・第一段階 第II相・第二段階 介入研究 臨床試験 です。現在は 募集中 で、2023年2月20日 から開始しています。100 名の参加者 の募集が計画されています。この治験は H. Lee Moffitt Cancer Center and Research Institute によって主催され、2026年8月22日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月22日 です。
概要
The purpose of the study is to evaluate a tele-resistance training exercise program for individuals undergoing chemotherapy for advanced upper gastrointestinal cancer.
公式タイトル
Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology (Remote REPS - GI)
疾患／病気
消化器癌その他の研究識別子
- MCC-21742
- 1K22CA262352-01 (米国NIHの助成金/契約)
NCT番号
開始日
2023-02-20
最終更新日
2025-09-22
終了予定日
2026-08-22
目標参加者数
100
試験の種類
介入研究
治験の相・段階
第I相・第一段階
第II相・第二段階
第II相・第二段階
状況
募集中
キーワード
Gastrointestinal Cancer
Remote Resistance Exercise
GI Cancer Stage III
GI Cancer Stage IV
Tele-Resistance Training
Remote Resistance Exercise
GI Cancer Stage III
GI Cancer Stage IV
Tele-Resistance Training
主目的
支持療法
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Tele-Resistance Training (RT) Participants will be encouraged to perform approximately 30 minutes of resistance training exercises approximately twice per week for 12 weeks. Participants will also be encouraged to perform moderate aerobic exercise at least 3 times per week. Participants will wear a FitBit fitness watch to monitor aerobic exercise. | Tele-resistance Training Tele-Resistance training sessions will be supervised and guided by a certified exercise trainer via smartphone, tablet or laptop. Exercises will be performed using resistance tubes (Bodylastics Resistance Bands Set) and a connectable bar (Bionic Body Workout Bar) that mimics a weighted barbell when tubes are attached. The tubes provide up to 142 pounds of resistance (adjustable in increments between 3-10 pounds) when simultaneously connected to handles or bar, and multiple tubes can be attached simultaneously. Participants will engage in brief warm up exercises lasting 2-3 minutes prior to each RT session and will rest at least 1 minute between sets of the same exercise to aid muscle recovery. Participants will perform at least 2 sets of 12 repetitions for each of 6 exercises. Including warm up, training sets, and rest, sessions will last approximately 30 minutes. RT will include six target exercises focusing on major muscle groups of the upper body, lower body, and core. |
非介入Usual Care (UC) Participants randomized to the Usual Care (UC) arm will be provided with information materials outlining resistance training using body weight or basic equipment. Participants will wear a FitBit fitness watch to monitor aerobic exercise. | 該当なし |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Percentage of Participants that Enroll and Consent - Enrollment Feasibility | Enrollment will be considered feasible if ≥ 70% of eligible and approached patients actually consent and enroll | Up to 36 Months |
Percentage of Participants that Complete Study Assessments - Retention Feasibility | Retention will be considered feasible if ≥ 70% of participants who complete baseline measures also complete followup measures | Up to 3 Months |
Exercise Adherence - Feasibility | Exercise adherence will be assessed based on performance of prescribed exercise volume, with tele-RT volumes considered feasible if participants perform ≥ 70% of the volume prescribed. | Up to 6 Months |
Participant Evaluation of Feasibility and Acceptability - Acceptability | Participants evaluation of feasibility and acceptability will be assessed with a questionnaire, adapted to fit the intervention. The questionnaire includes both Likert Scale and open-ended questions. An item-by-item basis and as average item score, with scores ≥4 ("agree" to "strongly agree") indicating acceptability. Open-ended responses will be analyzed qualitatively to inform intervention improvement. | Up to 6 Months |
Participant Self-Reported Musculoskeletal Injuries - Safety | Participants will be asked to report the following information: type (joint or soft tissue or other), location (specific body part), and cause (description of activity during which injury was incurred). Participants will then rate the injury on a scale of 1-4 (1=not related, 2=unlikely related, 3=likely related, 4=definitely related). The severity of the injury will be rated on a scale of 1-4 (1=mild/no change in daily activity, 2=some limitation of daily activity, 3=major limitation of daily activity, 4=life threatening). The duration for which daily activities were impacted will be rated on a scale from 1-5 (1=no change, 2=1-3 days, 3=4-7 days, 4=1-2 weeks, 5=more than 2 weeks). The numerator of the variable used to determine program safety will be the number of musculoskeletal injuries that were rated at least a 3 for relatedness to RT (likely related or definitely related) and caused at least some limitation of daily activity lasting more than 3 days. | Up to 6 Months |
Participant Muscular Strength - Baseline | Muscular strength will be measured using four separate 1-repetition maximum (1RM) lifts: chest press, seated row, leg press, and leg extension performed on resistance training machines. If a particular 1RM lift is contraindicated for a given participant (e.g., limited range of motion for a given joint or osteoporosis), the lift will be skipped, or 5-repetition maximum (5RM) will be measured instead of 1RM, and 1RM will be estimated from 5RM. | At Baseline |
Participant Muscular Strength - Follow-up | Muscular strength will be measured using four separate 1-repetition maximum (1RM) lifts: chest press, seated row, leg press, and leg extension performed on resistance training machines. If a particular 1RM lift is contraindicated for a given participant (e.g., limited range of motion for a given joint or osteoporosis), the lift will be skipped, or 5-repetition maximum (5RM) will be measured instead of 1RM, and 1RM will be estimated from 5RM. | Up to 6 Months |
Participant Muscular Endurance - Baseline | Muscular endurance will be measured by the maximum number of repetitions a participant can perform at 70% of the baseline 1-repetition maximum (1RM) for the same four lifts | At Baseline |
Participant Muscular Endurance - Follow-up | Muscular endurance will be measured by the maximum number of repetitions a participant can perform at 70% of the baseline 1-repetition maximum (1RM) for the same four lifts | Up to 6 Months |
Participant Skeletal Muscle Index (SMI) - Baseline | Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up. | At Baseline |
Participant Skeletal Muscle Index (SMI) - Follow-up | Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up. | Up to 6 Months |
Participant Skeletal Muscle Density (SMD) - Baseline | Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up. | At Baseline |
Participant Skeletal Muscle Density (SMD) - Follow-up | Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up. | Up to 6 Months |
Participants Health-Related Quality of Life | Health-related quality of life will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G) | Up to 6 Months |
Participant Fatigue | Participant fatigue will be measured using the FACT-Fatigue questionnaire (FACT-F) | Up to 6 Months |
Participant Physical Functioning | Participants physical functioning will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form | Up to 6 Months |
Participant Chemotherapy-induced peripheral neuropathy (CIPN) | Participant CIPN will be measured using the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20) | Up to 6 Months |
Participant Self Reported Exercise - Baseline | Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise | At Baseline |
Participant Self Reported Exercise - Follow-up | Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise | Up to 6 Months |
Participant Clinicodemographic Characteristics - Baseline | Participant clinicodemographic characteristics including tumor type and cancer stage, chemotherapy type, sex, age, body mass index, race/ethnicity, and marital status will be collected from participants' electronic medical records. | At Baseline |
Participant Clinicodemographic Characteristics - Follow-up | Participant clinicodemographic characteristics including tumor type and cancer stage, chemotherapy type, sex, age, body mass index, race/ethnicity, and marital status will be collected from participants' electronic medical records. | Up to 6 Months |
Participant Treatment Outcome | Participant relevant treatment outcomes including chemotherapy dose reductions and changes in chemotherapy will be collected from participants' electronic medical records. | Up to 6 Months |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Age ≥ 18 years
- Biopsy-proven upper GI cancer, stage III-IV
- ECOG performance status 0-1
- Treatment plan of chemotherapy with planned return to Moffitt Cancer Center for restaging
- Able to read and speak English fluently
- Capable of providing informed consent
- Regular engagement in RT (2x/week targeting all major muscle groups)
- Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q) and Patient-Reported Measurement Information System (PROMIS) screening questions
- Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV).
- Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT
- Numeric pain rating scale of ≥ 7 out of 10
- Myopathic or rheumatologic disease that impacts physical function
H. Lee Moffitt Cancer Center and Research Instituteアメリカ国立がん研究所3028 件のアクティブな治験を探索試験中央連絡先
連絡先: Nathan Parker, PhD, MPH, 813-745-0527, [email protected]
1 1カ国の場所
Florida
Moffitt Cancer Center, Tampa, Florida, 33612, United States
Nathan Parker, PhD, MPH, 連絡先, 813-745-0527, [email protected]
Nathan Parker, PhD, MPH, 研究責任者
Martine Extermann, MD, PhD, 副研究者
Rutika Mehta, MD, MPH, 副研究者
Pamela Hodul, MD, 副研究者
Jose Pimiento, MD, 副研究者
Richard Kim, MD, 副研究者
Dae Won Kim, MD, 副研究者
Mohammed Al-Jumayli, MD, 副研究者
Daniel Anaya Saenz, MD, 副研究者
Jason Denbo, MD, 副研究者
Sean Dineen, MD, 副研究者
Andrew Sinnamon, MD, 副研究者
Jason Fleming, MD, 副研究者
募集中