Clinical trial NCT04114422: A Seven-day Preoperative Exercise Training Program in People With Abdominal Cancer
Official title: A Feasibility Study for a Randomized Controlled Trial of a Seven-day Preoperative Exercise Training Program in People With Abdominal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Abdominal Cancer
Keywords: cancer
surgery
exercise training
physical therapy
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Preoperative exercise capacity
timeFrame: One day before and one day after seven-day preoperative exercise training program
Secondary outcomes:
measure: Peripheral muscle strength
timeFrame: One day before and one day after seven-day preoperative exercise training program
measure: Adherence rates
timeFrame: During 7 intervention days
measure: Adverse events
timeFrame: During 7 intervention days
measure: Subjective perception of satisfaction and discomfort of participants to the preoperative treatment.
timeFrame: On the day after finishing the intervention (8th day of the protocol)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Assistência Médica ao Servidor Público Estadual
Study officials:
affiliation: Universidade Cidade de São Paulo
name: Adriana Lunardi, PhD
role: STUDY_DIRECTOR
References: