A Seven-day Preoperative Exercise Training Program in People With Abdominal Cancer

A Feasibility Study for a Randomized Controlled Trial of a Seven-day Preoperative Exercise Training Program in People With Abdominal Cancer

Background: Preoperative exercise training programs of long duration, that delay surgical resection of tumors, may not be feasible in the treatment of malignant disease. In people with lung cancer, improvements in postoperative outcomes have been demonstrated with short duration (i.e. up to seven days) preoperative exercise training programs. However, the feasibility of short duration preoperative exercise training programs in people with abdominal cancer has not been investigated.

Objective: In people undergoing surgical resection for abdominal cancer, to investigate the effects of a seven-day preoperative exercise training program on preoperative exercise capacity and peripheral muscle strength as well as adherence rates, adverse events and subjective perception of satisfaction and discomfort of participants to the preoperative treatment.

Design: A feasibility study. Setting: Participants will be recruited from the surgical ward of a public hospital in São Paulo, Brazil.

Participants: 22 inpatients over 18 years old, awaiting surgical resection for colorectal, esophageal, gastric, hepatic or pancreatic cancer.

Intervention: The participants will undergo a seven-day, inpatient preoperative exercise training program that includes aerobic and resistance exercises.

Measurements: preoperative exercise capacity, peripheral muscle strength, adherence rates (consent rates, recruitment rates, completion rates and adherence), adverse events, the reasons for ineligibility and the reasons for declining participation and the subjective perception of satisfaction and discomfort of the participants to the preoperative treatment.

Study Overview

• Status: Withdrawn
• Conditions: Abdominal Cancer
• Intervention / Treatment: Other: Seven-day preoperative exercise training program

Detailed Description

Patients from the General Surgery ward at the Institute of Medical Assistance to Employed of São Paulo, Brazil, will be identified. Potential participants will be provided with a participant information sheet and, for those willing to participate in the study, a written informed consent will be obtained. The reasons for ineligibility and the reasons for declining participation will be recorded. Both before and following the intervention period, participants will complete assessments over a single day. Measures will be collected of: anthropometric and clinical data, preoperative exercise capacity and peripheral muscle strength. Following the completion of the intervention period, adherence rates (consent rates, recruitment rates, completion rates and adherence), adverse events and the subjective perception of satisfaction and discomfort of the participants to the preoperative treatment will also be recorded. The preoperative exercise training program will be supervised by a physiotherapist and will comprise aerobic exercise on a treadmill as well as strengthening exercises for the upper and lower limbs. The protocol will include 7 daily sessions of 60 minutes in duration. The first session will occur the day following the initial assessments. The treadmill exercise will start with a 5-minute warm-up and will progress to 30 minutes of exercise with a speed corresponding to 70% of the maximum speed reached in the incremental shuttle walk test. It will finish with a 5-minute cool down period. The intensity goal for the treadmill exercise will be to generate a rate of perceived exertion (on the dyspnea scale that ranges between 6 and 20) between 12 and 16. Exercise intensity (i.e. walking speed) will be progressively increased if the participant is able to walk for 30 minutes continuously reporting tolerable symptoms (dyspnea<12 points). Participants will also perform three strengthening exercises for the lower limbs (hip flexion, knee flexion and extension) and three for the upper limbs (shoulder flexion, elbow flexion and extension). The initial strengthening exercises intensity will be set at 60% of 1 Maximum Repetition and will be progressively increased. Patients will perform 3 sets of 8 to 12 repetitions for each exercise. The increment in exercise intensity will occur when the participant is able to perform at least 2 sets of 15 repetitions reporting tolerable symptoms (i.e. dyspnea<12 points).

Heart rate, peripheral oxygen saturation, dyspnea and blood pressure will be measured before, during (if needed; i.e. if symptoms are reported) and after each exercise training session. The session may be interrupted at any time if the patient presents major symptoms of dizziness, nausea or intolerable dyspnea/fatigue. Following surgery, all participants will receive routine physiotherapy care by the Physiotherapy team of the Institute of Medical Assistance to Employed of São Paulo

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adriana Lunardi, PhD; Phone Number: +551121781310; Email: adriana.lunardi@unicid.edu.br
• Study Contact Backup: Name: Isabel Garcia; Phone Number: +5511949914965; Email: isabelfialho@hotmail.com

Study Locations

• Brazil
  • São Paulo, Brazil, 04039-901
    • Instituto de Assistência Médica ao Servidor Público Estadual
    • Contact: Ivens Giacomassi; Phone Number: +5511967171732

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients are over 18 years of age;
• Diagnosis of colorectal, esophageal, gastric, hepatic or pancreatic cancer;
• Hospitalization at the Institute of Medical Assistance to Employed of São Paulo, awaiting major abdominal resection (i.e. ≥ 180 minutes in duration) with a curative intent;
• Being scheduled to be hospitalized for at least 11 days before surgical resection;
• Without previous treatment for their malignancy.

Exclusion Criteria:

• musculoskeletal conditions or cognitive impairment that interferes with the proposed assessments and intervention;
• serious diseases such as heart disease (moderate to severe pulmonary aortic stenosis, decompensated heart failure, advanced cardiac arrhythmias, myocarditis, unstable coronary insufficiency, for example), lung disease (obstructive pulmonary disease and / or decompensated asthma, for example), decompensated diabetes and decompensated systemic arterial hypertension
• participation in pulmonary rehabilitation or engagement in regular physical activity in the previous 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Seven-day preoperative exercise training program; All patients will undergo to seven-day preoperative exercise training program that includes aerobic and resistance exercises

Other: Seven-day preoperative exercise training program; The preoperative exercise training program will be supervised by a physiotherapist and will comprise aerobic exercise on a treadmill as well as strengthening exercises for the upper and lower limbs. The protocol will include 7 daily sessions of 60 minutes in duration. The treadmill exercise will start with a 5-minute warm-up and will progress to 30 minutes of exercise with a speed corresponding to 70% of the maximum speed reached in the incremental shuttle walk test. It will finish with a 5-minute cool down period. Participants will also perform three strengthening exercises for the lower limbs (hip flexion, knee flexion and extension) and three for the upper limbs (shoulder flexion, elbow flexion and extension). The initial strengthening exercises intensity will be set at 60% of 1RM and will be progressively increased. Patients will perform 3 sets of 8 to 12 repetitions for each exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative exercise capacity	Preoperative exercise capacity will be assessed via the incremental shuttle walk test. The test consists of walking on a 10 m course, around two cones positioned 9 m from each other and 0.5 m before of each end. The speed is dictated by audio signals recorded on a cell phone and progressively increases every minute. Participants will be instructed to follow the speed dictated by the audio signals until they are no longer able to keep up with the speed. The test will be terminated by either the participant, due to symptoms that make it impossible to maintain the required speed, or the assessor, if the participant fails to complete two shuttles in the time given or if the assessor judges the participant is unable to continue (e.g. peripheral oxygen saturation below 80%).	One day before and one day after seven-day preoperative exercise training program

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral muscle strength	Peripheral muscle strength will be assessed by a maximum repetition test (1RM). First, the participant will perform 3-5 minutes of light activities involving the muscle groups to be tested (hip flexors, knee flexors and extensors, elbow flexors and extensors). After one minute of light stretching, the patient will perform a warm up that includes eight repetitions at 50% of 1RM perceived, followed by three repetitions at 70% of 1RM perceived. The 1RM test will be conducted following a 5 minutes interval. Additional weights will be added as needed, and three to five attempts will be performed. The maximum weight lifted in a single movement will be recorded.	One day before and one day after seven-day preoperative exercise training program
Adherence rates	Adherence rates will be assessed by: consent rates (proportion of patients who agreed to participate in the study relative to those who were selected); recruitment rates (proportion of participants recruited relative to those who were eligible), completion rates (proportion of participants allocated that completed the intervention) and adherence (proportion of exercise training sessions completed). The reasons for ineligibility will be recorded. Reasons for declining participation will also be recorded for each patient who refuses to participate in the study.	During 7 intervention days
Adverse events	Adverse events (e.g. dizziness, nausea, falls, fatigue) will be systematically recorded throughout the intervention period.	During 7 intervention days
Subjective perception of satisfaction and discomfort of participants to the preoperative treatment.	Subjective perception of satisfaction and discomfort of participants to the preoperative treatment will be assessed, via 2 questions, on completion of the intervention period. Participants will rate their satisfaction and discomfort on a scale ranging between 0 and 10. For the question about treatment satisfaction, 0 will indicate "total dissatisfaction" and 10 "maximum satisfaction". In the question is about discomfort of treatment, 0 will indicate "no discomfort" and 10 "maximum discomfort".	On the day after finishing the intervention (8th day of the protocol)

Collaborators and Investigators

• Sponsor: Universidade Cidade de Sao Paulo
• Investigators: Study Director: Adriana Lunardi, PhD, Universidade Cidade de Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: cancer; surgery; physical therapy; exercise training
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Abdominal Neoplasms
• Other Study ID Numbers: UNICID/ 13004319.0.3001.5463

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No