Lung Cancer Exercise Training Study

NCT01068210 | Completed Results DMC

• 1 other identifier: 15-215
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Exercise Intervention; Lung Cancer; 15-215

Outcome Measures

Primary Outcomes (1)

• Changes in VO2peak (on Exercise Capacity)

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

  17 weeks

Study Arms (4)

Aerobic Training

EXPERIMENTAL

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.

Behavioral: Aerobic Training

Resistance Training

EXPERIMENTAL

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.

Behavioral: Resistance Training

Combined Aerobic and Resistance Training

EXPERIMENTAL

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.

Behavioral: Aerobic and Resistance Training

Progressive Stretching Group (Attention-Control)

ACTIVE COMPARATOR

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.

Behavioral: Progressive Stretching

Interventions

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.

Aerobic Training

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.

Progressive Stretching Group (Attention-Control)

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.

Resistance Training

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.

Combined Aerobic and Resistance Training

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Duke University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (2)

• Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.

  PMID: 39606939 DERIVED

• Scott JM, Thomas SM, Herndon JE 2nd, Douglas PS, Yu AF, Rusch V, Huang J, Capaci C, Harrison JN, Stoeckel KJ, Nilsen T, Edvardsen E, Michalski MG, Eves ND, Jones LW. Effects and tolerability of exercise therapy modality on cardiorespiratory fitness in lung cancer: a randomized controlled trial. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1456-1465. doi: 10.1002/jcsm.12828. Epub 2021 Oct 17.

  PMID: 34658160 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Lee Jones, PhD
• Organization: Memorial Sloan Kettering Cancer Center

jonesl3@mskcc.org

646-888-8103

Study Officials

• Lee Jones, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: February 12, 2010
• Study Start: October 1, 2015
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-03

Locations

US (1)