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

NCT04114422 | Withdrawn DMC

• 1 other identifier: UNICID/ 13004319.0.3001.5463
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Cancer

Keywords

cancer; surgery; exercise training; physical therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Peripheral muscle strength

  One day before and one day after seven-day preoperative exercise training program

• Adherence rates

  During 7 intervention days

• Adverse events

  During 7 intervention days

• Subjective perception of satisfaction and discomfort of participants to the preoperative treatment.

  On the day after finishing the intervention (8th day of the protocol)

Study Arms (1)

Seven-day preoperative exercise training program

EXPERIMENTAL

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

Other: Seven-day preoperative exercise training program

Interventions

Seven-day preoperative exercise training program OTHER

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.

Seven-day preoperative exercise training program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

Study Sites (1)

Instituto de Assistência Médica ao Servidor Público Estadual

São Paulo, 04039-901, Brazil

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Adriana Lunardi, PhD

  Universidade Cidade de São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 3, 2019
• Study Start: October 10, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

BR (1)