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TerminatedNCT06513663Updated Apr 27, 2026

Exercise as Maintenance Therapy in Advanced Lung Cancer

An interventional study of Exercise Intervention in Lung Cancer, Non Small Cell Lung Cancer and Metastatic Lung Cancer, sponsored by Indiana University. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by Indiana University · Not applicable, Interventional, and Supportive care

Why this study was terminated
trial stopped due to low accrual
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

This study is a randomized control trial at a single institution comparing advanced lung cancer patients undergoing supervised home-based exercise program versus usual care. The intervention is a supervised home-based exercise program that will be coordinated by the MOVE program. The regimen will be 12 weeks in duration, three times a week, and administered by a trained professional virtually.

Participants will be randomized 1:1 to the exercise or usual care arm. Participants will be stratified on baseline frailty by the SPPB.

Primary Objective To compare changes patient-reported fatigue (by FACT-F survey) from baseline to post-intervention in patients with locally advanced and advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.

Secondary Objectives

  1. To compare changes in cardiorespiratory fitness measured by VO2peak, estimated as time on the treadmill during ramp treadmill test, from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
  2. To compare changes in physical function measured by the short physical performance battery from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
  3. To compare changes in muscle mass and muscle density measured on CT scans for disease monitoring and bioimpedance analysis from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
  4. To compare changes in depression scores by HADS survey from baseline to post-intervention in patients with locally advanced and/or advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
  5. To compare the proportion of patients who are "fatigued," defined as a FACT-F score of \<43 at post-intervention between the exercise and usual care arms.
  6. To evaluate uptake and adherence of supervised home-based exercise program in patients with locally advanced and/or advanced lung cancer receiving maintenance immunotherapy or targeted therapy, measured by the percentage of patients who consented to the study and percentage of training sessions attended by patients in the exercise arm.
02

Conditions studied

  • Lung Cancer
  • Non Small Cell Lung Cancer
  • Metastatic Lung Cancer

Keywords

  • lung cancer
  • exercise
  • non small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 2 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years
  2. Known diagnosis of locally advanced (stage III) or metastatic NSCLC
  3. Patient is currently receiving maintenance immunotherapy for at least 1 month and planned for at least 3 additional months of therapy

    1. Patients receiving maintenance therapy refers to patients with stable disease or partial response to therapy, including patients who have had a history of disease progression but are currently stable or responding to a different therapy
    2. Patients previously receiving chemotherapy are eligible as long as at least one month has elapsed since completing chemotherapy. Those currently receiving chemotherapy are not eligible.
  4. Patient is willing and able to participate in a supervised home-based exercise program as determined by the MOVE program

    a.Participants must have internet access and equipment to participate in virtual exercise

  5. ECOG performance status of 0-2

Exclusion criteria

Exclusion Criteria:

  1. Already meeting exercise guidelines and participating in at least 150 minutes of moderate or vigorous exercise per IPAQ
  2. Unable to participate in the supervised home-based exercise program as determined by the MOVE program
  3. Medical co-morbidities that preclude patient from participating in supervised exercise, including but not limited to:

    • Advanced heart failure
    • Advanced respiratory disease requiring home oxygen use
    • Uncontrolled psychiatric disorders
    • History of fragility fracture
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Exercise 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.

    Behavioral: Exercise Intervention

  • No intervention
    Usual Care

    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.

Interventions

  • BehavioralExercise 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.

06

What researchers measure

Primary outcomes

  1. Change in patient-reported fatigue

    Measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) survey

    Time frame: baseline, week 12, and week 24

Secondary outcomes

  1. Change in cardiorespiratory fitness

    Measured by VO2peak, estimated as time on the treadmill

    Time frame: baseline, week 12, and week 24

  2. Change in physical performance battery

    total score on short physical performance battery

    Time frame: baseline, week 12, and week 24

  3. Change in muscle mass

    measured by mg/kg2 on HU on CT scans

    Time frame: baseline, and week 12

  4. Change in muscle density

    measured by mg/kg2 on HU on CT scans

    Time frame: baseline, and week 12

  5. Change in depression

    measured by total score of HADS survey

    Time frame: baseline, week 12, and week 24

  6. Proportion of patients who are "fatigued"

    measured by FACT-F score of \<43

    Time frame: baseline, week 12, and week 24

  7. Uptake of the study

    the proportion of total patients approached, screened, and ultimately completing the baseline assessments

    Time frame: date open to accrual until closed to accrual, up to 5 years

  8. Adherence with the intervention defined

    the proportion of scheduled sessions attended by participants randomized to the exercise intervention arm

    Time frame: baseline to post 12-week intervention

07

Study locations

3 sites
  • Indiana University Health Methodist Hospital
    Indianapolis, Indiana 46202, United States
  • Indiana University Melvin & Bren Simon Comprehensive Cancer Center
    Indianapolis, Indiana 46202, United States
  • Sidney and Lois Eskenazi Hospital
    Indianapolis, Indiana 46202, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06513663
Lead sponsor
Indiana University
Responsible party
Tarah J Ballinger, MD (Assistant Professor of Clinical Medicine, Indiana University) — Principal investigator
First posted
Jul 22, 2024
Start date
Oct 15, 2024
Primary completion
Jun 4, 2025
Completion
Jun 4, 2025
Last update
Apr 27, 2026

Study contacts

Tarah J Ballinger, MD
principal investigator · Indiana University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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