Pre Radiotherapy Daily Exercise Training in Non-Small Cell Lung Cancer

NCT ID: NCT03066271

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-03
• Study Completion Date: 2023-12-31

Brief Summary

The aim of this study is to evaluate the feasibility and the effect of daily, individual, supervised and structured exercise training before radiotherapy in patients diagnosed with Non-Small Cell Lung Cancer. Primary outcome is maximal oxygen uptake (VO2peak). The hypotheses are that patients who undergo daily exercise training will increase VO2peak, functional capacity (measured by 6-minute walk test (6MWD)) and lung function (forced expired volume in one second (FEV1)).

Detailed Description

Pre intervention screening: Each patient was screened by a clinical nurse specialist prior to participating in the study. Before baseline and post test the patient was screened by a research physiotherapist and/or human physiology students. If one of the following criteria were met, the patient was prohibited from being tested on that day: diastolic blood pressure <45 or >95, heart rate (HR) at rest >115/min, temperature > 38 0C, respiratory rate at rest >30/min, infection requiring treatment, fresh bleeding, total leucocyte count <1.0 109/L or platelets <50 109/L.

Control - Usual care: The patients randomized to the control group received no training but conducted baseline and post test (6MWD, spirometry, VO2peak and questionnaires) just as the intervention group. Furthermore, patients in control were equipped with a Garmin vivo-smart HR® activity tracker every day in 24h during the course of radiotherapy treatment.

Intervention - The patients randomized to the intervention group received daily training and conducted baseline and post test (6MWD, spirometry, VO2peak and questionnaires). Furthermore, patients were equipped with a Garmin vivo-smart HR® activity tracker every day in 24h during the course of radiotherapy treatment.

The supervised daily training was carried out individually and each session had a duration of 20 minutes before patients individual prescribed radiotherapy. Training was conducted at National Hospital of Denmark: Department of Radiation Oncology , section 3981, entry 39. supervised by a research physiotherapist and/or human physiology students.

Statistical analysis sample size: According to the sample size the calculation is performed on the basis of alteration in VO2peak from the study "EXHALE" (55 patients who completed a 6 weeks training period). The calculation is based on an increase of 200 ml/min in VO2peak for patients in the intervention group (SD = 2,48) and it is assumed that the patients in the control group will have a reduction of 100 ml/min (SD = 2,48). Assumptions for calculation of patient numbers are as follows: Type 1 error 0.05, type 2 error 0.20, SD 2.48.

This leads to a total number of 24 patients (12 in each arm). A drop-out rate of 40% is included. Therefore another 16 patients is added, which gives a sample size of 40 patients (20 in each arm).

Data entry is carried out in the Open Clinica and data analyses will be performed using the computer programs R-Studio/R and SPSS. Data from questionnaires will be analyzed by SPSS. All other data will be analyzed by R.

Differences between groups will be analyzed by an unparried t-test whereas differences within groups will be analyzed by a parried t-test. All categorical data are analyzed using the Pearson χ2 tests. Other data (e.g., from questionnaires) are analyzed using logistic regression and chi square or Mantel Haenzel test. Significance level is set at 0.05.

Conditions

Non-Small Cell Lung Cancer Stage; Chemoradiation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Exercise + usual care

The supervised exercise training is carried out on a ergometer cycle as individual daily (mon-fri) training and each exercise training session consists of 20min.

The training comprised a warm-up phase followed by 3 exercise phases. Warm-up consisted of 5min light stationary cycling, adjusted to 50-60% of the patients peak power output determine at the incremental cycle test (iPPO). The first exercise phase comprised of 5min interval training consisting of 5x30 sec intervals at 80-95% of the patient's iPPO. Between each interval, there is a 30 sec pause. The 2nd exercise phase consisted of 5min continuous cycling at an intensity equaling 80% of the patient's iPPO. The 3rd exercise phase was similar to the first exercise phase. Intensities increased progressively from the first week to the last week (from 50%, 80% and 70% of iPPO according to the three different phases to 60%, 95% and 80 % of iPPO respectively.

Group Type: EXPERIMENTAL

Exercise +

Intervention Type: OTHER

Usual care

Control - usual care

The patients randomized to the control group received no training but will be wearing the activity tracker during the intervention.

Group Type: EXPERIMENTAL

Control +

Intervention Type: OTHER

Usual care

Interventions

Exercise +

Usual care

Intervention Type: OTHER

Control +

Usual care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with NSCLC who are treated with concomitant chemo- and radiotherapy.
• Age: > 18 year
• WHO performance status 0-1

Exclusion Criteria

• Patients with any symptoms or circumstances that advise against physical activity.
• Symptomatic heart disease e.g. arrhythmia or myocardial infarction within the last three months.
• Congestive heart failure
• Patients who do not read and speak Danish.
• Brain or bone metastases;
• Prolonged bone marrow suppression
• Anti-coagulant treatment
• Inability to provide informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Morten Quist

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Morten Quist, Post. doc

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

University Hospital of Copenhagen

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-16048479

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

JRTE

Identifier Type: -

Identifier Source: org_study_id