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Clinical Trials/NCT05664178
NCT05664178
Recruiting
Phase 1

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

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country100 target enrollmentFebruary 20, 2023

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Gastrointestinal Cancer
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Enrollment
100
Locations
1
Primary Endpoint
Percentage of Participants that Enroll and Consent - Enrollment Feasibility
Status
Recruiting
Last Updated
4 months ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
February 20, 2023
End Date
August 22, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Percentage of Participants that Enroll and Consent - Enrollment Feasibility

Time Frame: Up to 36 Months

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

Participant Muscular Strength - Baseline

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Up to 6 Months

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

Participant Fatigue

Time Frame: Up to 6 Months

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

Participant Chemotherapy-induced peripheral neuropathy (CIPN)

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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