Impact of Prehabilitation in Oncology Via Exercise- Esophageal (IMPROVE-Esophageal)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About this trial
The goal of this study is to determine the feasibility of a prehabilitation exercise and nutrition program (exercise and nutrition before a medical treatment) in adults with esophageal cancer before surgery (esophagectomy). The pre-surgery exercise and nutrition program will include resistance and aerobic training and nutrition supplementation during the weeks before surgery. We will also assess pre-surgical care needs in adults with esophageal cancer. Researchers will compare the exercise and nutrition intervention to usual care- which is standard medical care and post-surgery surveillance/follow-up to understand the impact of exercise and nutrition before surgery. We will follow-up with participants before surgery, and after surgery at 2 weeks, 6 weeks, and 4-months at appointments that coincide with clinical follow-ups.
The main questions of this trials are:
* Is exercise and nutrition supplementation before surgery for esophageal cancer feasible and acceptable to patients? * How does exercise and nutrition supplementation before surgery change physical function and psychosocial health? * What are important pre-surgical needs for adults with esophageal cancer?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women, age ≥ 18 years old
Diagnosed with esophageal cancer
Identified as esophagectomy surgery candidates at Hillman Cancer Center, UPMC Shadyside, or UPMC Passavant
≥ 2 weeks until scheduled esophagectomy
Disqualifiers
Evidence in the medical record of an absolute contraindication for exercise (e.g., Heart insufficiency > NYHA III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability)
Any other comorbidities or musculoskeletal complications that preclude participation in the exercise programs as deemed by the exercise interventionist
Receiving non-esophagectomy related chemotherapy and/or radiotherapy
Active infections, hemorrhages, and cytopenias that could place surgical patients at risk for further adverse events, deemed by the exercise interventionist, physician, and/or nurse
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise and Nutrition
BehavioralThe exercise and nutrition intervention will last up to 8 weeks and will include: * 3-5 times per week of resistance training and 3-5 times per week of aerobic training. The prescribed exercise will be personalized based on the participant's baseline functionality. * Ensure Complete nutrition supplement drinks: 2 per day starting on the same day the exercise begins, up until 5 days prior to surgery.
Usual Care Group
BehavioralThe CONT group will not receive any intervention during study participation and undergo usual medical treatment and surveillance during the duration of the study.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Home-based prehabilitation exercise and nutrition (PRE)Experimental treatment 1 intervention
Group B: Usual Care (CONT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Acceptability of Intervention
Acceptability is defined as the proportion of approached participants who agree to participate and complete the baseline assessments and be randomized.
Time frame
From enrollment through surgical admission, up to 8 weeks2
Adherence to Intervention
Exercise adherence will be calculated as the proportion of completed exercise sessions over the number of prescribed sessions.
Time frame
From enrollment through surgical admission, up to 8 weeks3
Feasibility of Intervention
The intervention will be considered feasible if 50% of participants complete approximately 70% of prescribed prehabilitation sessions prior to their surgical admission.
Time frame
From enrollment through surgical admission, up to 8 weeksSecondary outcomes
1
Six-minute walk test (6MWT)
Cardiorespiratory fitness will be measured using the six minute walk test. The 6MWT is an objective evaluation of functional exercise capacity. Its results are highly correlated with those of the 12-minute walk test from which it was derived and with those of cycle ergometer or treadmill-based exercise tests.
Time frame
Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy2
2-Minute Step Test
Cardiorespiratory fitness will be measured with the 2-minute step test. Participants will be marching in place for 2 minutes and are encouraged to use a chair for balance or do the assessment seated if standing is too difficult. They should be lifting their legs about 6 inches off the ground, as if they were stepping onto a curb from the road. The tester will count the number of times the participant raises their right leg off the ground.
Time frame
Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy3
30-second chair stand test (30CST)
Lower body strength will be evaluated using the 30 second chair stand test. The participant is seated in the middle of the chair, back straight, feet approximately shoulder width apart and placed on the floor. Arms are crossed at the wrists and held against the chest. At the signal "go," the participant rises to a full body stand and then returns to the initial seated position. The participant is encouraged to complete as many full stands as possible within 30 seconds.
Time frame
Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomy4
Timed-Up-and-Go (TUG) test
The TUG evaluates lower body strength, balance, and agility. The patient sits in a chair and on the command "go", the patient rises from the chair, walks 3 meters at a self-selected pace, turns around an obstacle, walks back to the chair and sits down. Test results may also be quantified assessing the time (seconds) needed to complete the assessment.
Time frame
Baseline, Time of Admission, and 2 Weeks/6 Weeks/4 Months post esophagectomySponsors and contacts
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Source ClinicalTrials.gov