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临床试验/NCT05664178
NCT05664178已完成1 期

Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology (Remote REPS - GI)

H. Lee Moffitt Cancer Center and Research Institute2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年2月20日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
22
试验地点
2
主要终点
Percentage of Participants that Enroll and Consent - Enrollment Feasibility

研究概览

简要总结

The purpose of the study is to evaluate a tele-resistance training exercise program for individuals undergoing chemotherapy for advanced upper gastrointestinal cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Tele-Resistance Training (RT)

Experimental

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.

干预措施: Tele-Resistance Training (Behavioral)

Usual Care (UC)

No Intervention

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.

结局指标

主要结局

Percentage of Participants that Enroll and Consent - Enrollment Feasibility

时间窗: Up to 36 Months

Enrollment will be considered feasible if ≥ 70% of eligible and approached patients actually consent and enroll

Participant Muscular Strength - Baseline

时间窗: At 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.

Participant Clinicodemographic Characteristics - Follow-up

时间窗: Up to 6 Months

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.

Exercise Adherence - Feasibility

时间窗: Up to 6 Months

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.

Participant Self-Reported Musculoskeletal Injuries - Safety

时间窗: Up to 6 Months

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.

Participant Muscular Endurance - Follow-up

时间窗: Up to 6 Months

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

Participant Skeletal Muscle Index (SMI) - Baseline

时间窗: At Baseline

Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.

Participant Skeletal Muscle Index (SMI) - Follow-up

时间窗: Up to 6 Months

Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.

Participant Skeletal Muscle Density (SMD) - Follow-up

时间窗: Up to 6 Months

Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.

Participant Muscular Strength - Follow-up

时间窗: Up to 6 Months

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.

Participant Self Reported Exercise - Baseline

时间窗: At Baseline

Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise

Participant Self Reported Exercise - Follow-up

时间窗: Up to 6 Months

Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise

Participant Treatment Outcome

时间窗: Up to 6 Months

Participant relevant treatment outcomes including chemotherapy dose reductions and changes in chemotherapy will be collected from participants' electronic medical records.

Percentage of Participants that Complete Study Assessments - Retention Feasibility

时间窗: Up to 3 Months

Retention will be considered feasible if ≥ 70% of participants who complete baseline measures also complete followup measures

Participant Skeletal Muscle Density (SMD) - Baseline

时间窗: At Baseline

Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.

Participants Health-Related Quality of Life

时间窗: Up to 6 Months

Health-related quality of life will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G)

Participant Fatigue

时间窗: Up to 6 Months

Participant fatigue will be measured using the FACT-Fatigue questionnaire (FACT-F)

Participant Chemotherapy-induced peripheral neuropathy (CIPN)

时间窗: Up to 6 Months

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)

Participant Evaluation of Feasibility and Acceptability - Acceptability

时间窗: Up to 6 Months

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.

Participant Muscular Endurance - Baseline

时间窗: At 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

Participant Physical Functioning

时间窗: Up to 6 Months

Participants physical functioning will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form

Participant Clinicodemographic Characteristics - Baseline

时间窗: At 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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