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Completed

NCT Number: NCT01068210

Lung Cancer Exercise Training Study

The purpose of the study is look at the effects of different types of exercise training with a stretching group and its effect on lung cancer patients. Subjects will take part in a 16 week training intervention that can consist of aerobic, resistance, aerobic & resistance, or a control group. Pre and Post testing will include stress tests, echos, blood, and urine samples.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent prior to initiation of study-related procedures
  • Age 21 - 80 years
  • Weight < 205 kgs
  • ECOG ≤ 1
  • Diagnosed with histologically confirmed lung cancer, regardless of disease stage and receiving any prior line of any therapy in the context of metastatic disease
  • An interval of at least three months following the completion of primary resection, if appropriate
  • An interval of no longer than ten years following completion of primary therapy, if appropriate
  • Life expectancy ≥ 4 months
  • Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week
  • Exercise intolerance (i.e., patients must have a VO2peak below that predicted for active age and sex-matched individuals)
  • Willing to be randomized to one of the study arms
  • Willing to commit to the study program and comply with all related protocol procedures
  • Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:
  • achieving a plateau in oxygen consumption, concurrent with an increase in power output;
  • a respiratory exchange ratio ≥ 1.10;
  • attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]);
  • volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
  • Able to complete an acceptable baseline CPET in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the PI.
  • Ability to achieve and complete an acceptable baseline one-repetition maximum muscular strength test as defined by the effective execution of protocol-specific joint and muscle ranges of motion without remarkable signs or symptoms of pain, discomfort or distress.

Exclusion criteria

  • Presence of a concurrent, actively treated other malignancy, or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer);
  • Room air desaturation at rest ≤ 85%;
  • Mental impairment leading to inability to cooperate.
  • Any of the following absolute contraindications to cardiopulmonary exercise testing:
  • Acute myocardial infarction (within 3-5 days of any planned study procedures);
  • Unstable angina;
  • Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
  • Recurrent syncope;
  • Active endocarditis;
  • Acute myocarditis or pericarditis;
  • Symptomatic severe aortic stenosis;
  • Uncontrolled heart failure;
  • Acute (within 3 months) pulmonary embolus or pulmonary infarction;
  • Thrombosis of lower extremities;
  • Suspected dissecting aneurysm;
  • Uncontrolled asthma;
  • Pulmonary edema;
  • Respiratory failure;
  • Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)

Treatment and study plan

Aerobic training

Behavioral

The overall goal for all the exercise training groups will be 3 supervised exercise sessions per week an intensity between 50 to 100% of the individually determined VO2peak for aerobic training and an intensity between 50% to 85% of 1-RM for resistance training. All the exercise interventions are designed such that participants begin exercising at a low intensity (~50%-60% VO2peak / 1RM) that is subsequently increased to more moderate to vigorous intensity (~70%-100% VO2peak / ~70-85% 1RM) when appropriate. All interventions will be individually tailored to each patient following the principles of aerobic or resistance training prescription guidelines for adults.

Progressive Stretching

Behavioral

The ultimate goal for the progressive stretching program is 3 individual stretching sessions. All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.

Resistance training

Behavioral

The ultimate goal for resistance training alone is 3 resistance training session/week at an intensity above 50% to 85% of 1-RM for 30-60 minutes/session. Resistance trainings will be performed on stationary weight machines, modification in equipment may be made by Exercise Physiologist. Participants will be progressively trained to perform two to three sets of 75-85% of maximal strength.

Aerobic and resistance training

Behavioral

The ultimate goal will be three combined exercise sessions per week at an intensity above 50% VO2speak and above 50% 1-RM for aerobic and resistance training, respectively for 30-90 minutes/session.

Primary outcomes

  1. Changes in VO2peak (on Exercise Capacity)

    Time frame: 17 weeks

    To compare the efficacy of different types of exercise training modalities, relative to progressive stretching (attention control group)

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Duke University
  • National Cancer Institute (NCI)

Registry information

Official study title

Lung Cancer Exercise Training Study: A Randomized Trial of Aerobic Training, Resistance Training, or Both in Lung Cancer Patients

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2010
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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