Lung Cancer Exercise Training Study

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Lung Cancer

Treatments: Behavioral: Resistance Training; Behavioral: Aerobic and Resistance Training; Behavioral: Progressive Stretching; Behavioral: Aerobic Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01068210

15-215

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 4 patient groups

Aerobic Training

Experimental group

Description:

A customized and supervised endurance exercise training program that will last 4 months (16 weeks). The regimen will be tailored to the individual fitness level. The exercise program will consist of three supervised sessions per week. During each session, the participant will cycle on a stationary bicycle at moderate intensity for approximately 30-60 minutes.

Treatment:

Behavioral: Aerobic Training

Resistance Training

Experimental group

Description:

A customized and supervised resistance exercise training program that will last 4 months (16 weeks). Resistance training will be performed on stationary weight machines, modification in equipment may be made by Exercise Physiologist. Patients will be progressively trained to perform two to three sets of 75-85% of maximal strength The participant will be trained to perform different resistance exercise, alternating between lower and upper body muscle groups. The exercise program will consist of three supervised sessions per week. Each session will last approximately 30-60 minutes.

Treatment:

Behavioral: Resistance Training

Combined Aerobic and Resistance Training

Experimental group

Description:

A customized and supervised endurance exercise training program that will last 4 months (16 weeks). The regimen will be tailored to the individual fitness level, and will be a combination of Arm A and Arm B, described above. At each session, the participant will complete aerobic training on a stationary bicycle and also resistance training using stationary weight machines. The exercise program will consist of three supervised sessions per week. Each session will last approximately 30-90 minutes.

Treatment:

Behavioral: Aerobic and Resistance Training

Progressive Stretching Group (Attention-Control)

Active Comparator group

Description:

A customized and supervised progressive stretching program that will last 4 months (16 weeks). The progressive stretching program will consist of a series of stretching exercises alternating between lower and upper body muscle groups/joints. This program will consist of three exercise sessions a week. Each session will last approximately 30-60 minutes.

Treatment:

Behavioral: Progressive Stretching