Abdominal CancerNCT04114422
A Seven-day Preoperative Exercise Training Program in People With Abdominal Cancer
A study testing Seven-day preoperative exercise training program in people with Abdominal Cancer, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Cancer
- What is being tested?
- Seven-day preoperative exercise training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Oct 2019to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Assistência Médica ao Servidor Público Estadual
São Paulo, 04039-901
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Abdominal Cancer
- Being tested
- Seven-day preoperative exercise training program
- Keywords
- cancer, surgery, exercise training, physical therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seven-day preoperative exercise training programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Seven-day preoperative exercise training program | Experimental | All patients will undergo to seven-day preoperative exercise training program that includes aerobic and resistance exercises Receives: Other: Seven-day preoperative exercise training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: One day before and one day after seven-day preoperative exercise training program
Secondary outcomes (4)
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.
Measured: 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.
Measured: During 7 intervention days
Adverse events
Adverse events (e.g. dizziness, nausea, falls, fatigue) will be systematically recorded throughout the intervention period.
Measured: 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".
Measured: On the day after finishing the intervention (8th day of the protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start10 Oct 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Claudia Lunardi, Universidade Cidade de Sao Paulo
- Investigators
- Adriana Lunardi, PhD, Study director, Universidade Cidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114422
- Sponsor's protocol ID
- UNICID/ 13004319.0.3001.5463
- Status last verified
- Jun 2023
- First submitted
- 30 Sep 2019
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for a Randomized Controlled Trial of a Seven-day Preoperative Exercise Training Program in People With Abdominal Cancer
- ClinicalTrials.gov ID
- NCT04114422
- Acronym / sponsor ID
- UNICID/ 13004319.0.3001.5463
- Conditions
- Abdominal Cancer
- Keywords
- cancer, surgery, exercise training, physical therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seven-day preoperative exercise training program | Experimental | Other: Seven-day preoperative exercise training programAll patients will undergo to seven-day preoperative exercise training program that includes aerobic and resistance exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seven-day preoperative exercise training programThe 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. | Other | Seven-day preoperative exercise training program |
Primary outcome
Preoperative exercise capacity
Time frame: One day before and one day after seven-day preoperative exercise training program
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%).
4 secondary outcomes
Peripheral muscle strength
Time frame: One day before and one day after seven-day preoperative exercise training program
Adherence rates
Time frame: During 7 intervention days
Adverse events
Time frame: During 7 intervention days
Subjective perception of satisfaction and discomfort of participants to the preoperative treatment.
Time frame: On the day after finishing the intervention (8th day of the protocol)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Lunardi, PhD study director
Universidade Cidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seven-day preoperative exercise training program in people with Abdominal Cancer, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative exercise capacity (time frame: One day before and one day after seven-day preoperative exercise training program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.