Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05664178
• Other study ID #: MCC-21742
• Secondary ID: 1K22CA262352-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 20, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Nathan Parker, PhD, MPH
• Phone: 813-745-0527
• Email: Nathan.Parker[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2025
• Est. primary completion date: February 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Participant Fatigue	Participant fatigue will be measured using the FACT-Fatigue questionnaire (FACT-F)	Up to 6 Months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Moffitt Cancer Center Clinical Trials Search