100 Participants Needed

Exercise for Lung Cancer

Recruiting at 2 trial locations
NK
MP
Tarah J. Ballinger, MD | IU Health
Overseen ByTarah Ballinger, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
Must be taking: Immunotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine how a multimodality (having or using a variety of methods to do something) exercise intervention may improve survival, function, and quality of life in participants with advanced lung cancer.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, you must be on maintenance immunotherapy for at least one month and cannot be currently receiving chemotherapy.

What data supports the effectiveness of the treatment Exercise Intervention, Physical Activity Intervention, Exercise Program, Aerobic and Resistance Training for lung cancer?

Research shows that exercise can improve physical and functional capacity, quality of life, and reduce anxiety and depression in lung cancer patients. Studies indicate that structured exercise programs, including aerobic and resistance training, are beneficial for lung cancer patients, although more decisive evidence is needed for advanced stages.12345

Is exercise safe for people with lung cancer?

Research shows that exercise is generally safe for people with lung cancer, with studies focusing on its safety, feasibility, and effectiveness. However, the reporting of adverse events (unwanted effects) in exercise trials is not always consistent, so more standardized reporting is needed to fully understand safety.23678

How is the exercise intervention treatment for lung cancer different from other treatments?

The exercise intervention for lung cancer is unique because it focuses on improving physical strength and endurance through activities like aerobic and resistance training, rather than using medication or surgery. It is considered a safe and feasible addition to traditional treatments, helping to enhance quality of life and manage symptoms across all stages of lung cancer.39101112

Research Team

TJ

Tarah J Ballinger, MD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for adults over 18 with advanced lung cancer (stage III or metastatic NSCLC) who are on maintenance immunotherapy. They must have internet and equipment for virtual exercise, be stable or responding to current therapy, and not already doing regular moderate/vigorous exercise. Excluded are those with severe heart/respiratory conditions, uncontrolled psychiatric disorders, or a history of fragile bones.

Inclusion Criteria

Participants must have internet access and equipment to participate in virtual exercise
My lung cancer is at stage III or has spread beyond.
I have been on immunotherapy for at least 1 month and will continue for 3 more months.
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Exclusion Criteria

Already meeting exercise guidelines and participating in at least 150 minutes of moderate or vigorous exercise per IPAQ
Unable to participate in the supervised home-based exercise program as determined by the MOVE program
I do not have severe heart or lung problems, uncontrolled mental health issues, or a history of easy bone fractures that would stop me from doing supervised exercise.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a supervised home-based exercise program three times weekly for 12 weeks

12 weeks
36 virtual sessions

Follow-up

Participants are monitored for changes in fatigue, cardiorespiratory fitness, physical function, muscle mass, and depression scores

12 weeks
Assessments at baseline, week 12, and week 24

Long-term follow-up

Participants are monitored for long-term outcomes and adherence to the exercise program

Up to 5 years

Treatment Details

Interventions

  • Exercise Intervention
Trial Overview The study tests how an at-home multimodal exercise program affects survival, function, and quality of life in patients with advanced lung cancer. Participants will engage in supervised exercises virtually while continuing their maintenance immunotherapy treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise InterventionExperimental Treatment1 Intervention
Eligible and consented participants randomized to the exercise arm will work with an exercise trainer three times weekly for 12 weeks. Training sessions will be delivered virtually using HIPPA Complaint IU Health Zoom. These sessions will last 60 minutes and include cardiovascular exercise, resistance training, and balance or stretching exercise. The participants will be able to use any equipment they already have at home but will be provided a heart monitor and a set of resistance bands. All sessions will have a moderate-intensity training goal, defined as 40-80% of heart rate reserve (HRR). Cardiovascular exercise will include any at-home equipment available to the participants or follow a Tabata-style program. Resistance training will include a full body workout, emphasizing all major muscle groups. Trainers will progress or regress intensity levels based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session.
Group II: Usual CareActive Control1 Intervention
Participants randomized to usual care arm will receive care per their treatment team. Usual care participants are encouraged to exercise but will not be provided components of the intervention. Participants in the usual care arm will be given usual care handouts at baseline.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Findings from Research

Lung cancer survivors showed a preference for starting exercise programs during adjuvant treatment, especially those who had undergone lung surgery, indicating the importance of tailoring exercise timing to individual treatment experiences.
Exercise levels significantly declined after diagnosis, but engaging in exercise post-treatment was associated with improved quality of life and reduced fatigue, highlighting the potential benefits of exercise for recovery in lung cancer survivors.
Exercise preferences, levels and quality of life in lung cancer survivors.Leach, HJ., Devonish, JA., Bebb, DG., et al.[2018]
The study assessed the feasibility of an 8-week hospital-based exercise program for 25 patients with advanced non-small cell lung cancer, finding that while 80% started the program, only 44% completed all sessions.
Patients who completed the exercise program reported significant improvements in lung cancer symptoms without any decline in their functional capacity, suggesting that structured exercise can be beneficial for those who can adhere to it.
A structured exercise program for patients with advanced non-small cell lung cancer.Temel, JS., Greer, JA., Goldberg, S., et al.[2021]
Exercise interventions for lung cancer patients significantly reduce post-operative complications and improve exercise capacity, based on a systematic review of 30 studies involving a total of 6440 participants.
While exercise showed benefits in pre- and post-operative settings, health-related quality of life improvements were mostly non-significant, indicating a need for further high-quality research, especially in non-surgical populations.
Exercise across the Lung Cancer Care Continuum: An Overview of Systematic Reviews.Edbrooke, L., Bowman, A., Granger, CL., et al.[2023]

References

Exercise preferences, levels and quality of life in lung cancer survivors. [2018]
A structured exercise program for patients with advanced non-small cell lung cancer. [2021]
Exercise across the Lung Cancer Care Continuum: An Overview of Systematic Reviews. [2023]
"EXHALE": exercise as a strategy for rehabilitation in advanced stage lung cancer patients: a randomized clinical trial comparing the effects of 12 weeks supervised exercise intervention versus usual care for advanced stage lung cancer patients. [2021]
Effects of Preoperative High-Intensity Interval Training Combined With Team Empowerment Education in Lung Cancer Patients With Surgery: A Quasi-experimental Trial. [2023]
Exercise for Individuals With Lung Cancer: A Systematic Review and Meta-Analysis of Adverse Events, Feasibility, and Effectiveness. [2021]
Physical Activity and Exercise in Lung Cancer Care: Will Promises Be Fulfilled? [2021]
Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]
Physical activity and lung cancer survivorship. [2015]
The importance of exercise in lung cancer treatment. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Exercise therapy across the lung cancer continuum. [2021]
Physical activity for people with lung cancer. [2020]