Lung CarcinomaNCT07553819
Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers
A study testing Accelerometry, Aerobic Exercise and Biospecimen Collection in people with Lung Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This clinical trial studies whether home-based respiratory muscle training (RMT) and aerobic exercise (AE) programs can be used to improve lung health in current and former cigarette smokers. Lung cancer, the leading cause of cancer death, is overwhelmingly caused by exposure to cigarette smoke. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Accelerometry, Aerobic Exercise and Biospecimen Collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years old
- Current smoker with a ≥ 20-pack-years history
- Former smoker within the past 15 years, with a history of ≥ 20 pack-years (CT scan cohort only)
- Participant must be able to speak, read and comprehend English language
- Cognitively capable of following direction and performing the intervention
- Understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Who cannot join
- Any previous lung cancer diagnoses and or undergoing treatment for any cancer
- Recent pneumonia, bronchitis, or other inflammatory conditions in the lungs, including but limited to chronic obstructive pulmonary disease (COPD) and/or asthma exacerbation within the previous 6 months
- Have uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness/social situations that would limit compliance with study requirements
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
Andrew D. Ray, 716-845-2381, Andrew.Ray@RoswellPark.org
Andrew D. Ray
About this study
Official title: Effects of Respiratory Muscle Training and Aerobic Exercise on Lung Health in Smokers: A Pilot Parallel-Group Study for Lung Cancer Prevention
This clinical trial studies whether home-based respiratory muscle training (RMT) and aerobic exercise (AE) programs can be used to improve lung health in current and former cigarette smokers. Lung cancer, the leading cause of cancer death, is overwhelmingly caused by exposure to cigarette smoke. Research suggests that daily activity reduces lung cancer risk in current and former smokers. However, current and former smokers are generally not active and new approaches to improve lung health are needed. During the home-based RMT program, participants use a handheld device to complete breathing exercise sessions consisting of breathing in and out against adjustable resistance. During the home-based AE program, participants complete aerobic exercises using a stationary bike working at a moderate workload against adjustable resistance. The home-based RMT and AE programs may be effective ways to strengthen the breathing muscles, which may improve lung health in current and former cigarette smokers.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate the feasibility of delivering a home-based AE and RMT program in individuals at high risk for lung cancer.
II. Assess the effects of AE and RMT on patient-reported outcomes (PROs), including QoL, fatigue, dyspnea, performance metrics such as respiratory muscle strength and lower extremity strength; the 6-minute walk test; and daily activity levels in high-risk individuals.
III. Investigate whether RMT and/or AE improve peripheral and exhaled biomarkers associated with lung injury, inflammation, and/or oxidative stress.
OUTLINE: Participants scheduled for a computed tomography (CT) scan are assigned to cohort A, participants who call the New York State Quitline (NYSQL) are assigned to cohort B.
COHORT A: Participants are randomized to 1 of 3 arms.
ARM I: Participants complete RMT sessions via the Power Lung device over 20-30 minutes each consisting of three sets of 15 breaths at a gradual increase in resistance, 5 days a week, for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call once a week (QW) to provide support, enhance safety, and promote training compliance on study.
ARM II: Participants complete tailored intensity AE cycling sessions progressing to over 30 minutes each, 5 days a week, for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call QW to provide support, enhance safety, and promote training compliance on study.
ARM III: Participants receive education on AE and RMT including recommendations aligned with current guidelines 5 days a week for 12 weeks.
COHORT B: Participants are randomized to 1 of 2 arms.
ARM IV: Participants complete RMT sessions as in arm I for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call QW to provide support, enhance safety, and promote training compliance on study.
ARM V: Participants receive education on AE and RMT as in arm III on study.
Additionally, all patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study.
After completion of study intervention, participants may be optionally followed up at week 24.
- Conditions
- Lung Carcinoma
- Being tested
- Accelerometry, Aerobic Exercise, Biospecimen Collection, Educational Intervention, Electronic Health Record Review
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometryProcedure or surgery
Ancillary studies
Aerobic ExerciseOther
Also called Aerobic Activity
Complete tailored intensity AE cycling sessions
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood, nasal swab, exhaled breath, and urine sample collection
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive AE and RMT education
Electronic Health Record ReviewOther
Ancillary studies
Physical Performance TestingOther
Also called Physical Fitness Testing, Physical Function Testing
Ancillary studies
Respiratory Muscle TrainingProcedure or surgery
Also called RMT
Complete RMT sessions
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive virtually supervised session/call
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Cohort A Arm I (RMT) | Experimental | Participants complete RMT sessions via the Power Lung device over 20-30 minutes each consisting of three sets of 15 breaths at a gradual increase in resistance, 5 days a week, for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call QW to provide support, enhance safety, and promote training compliance on study. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study. Receives: Procedure: Accelerometry; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Physical Performance Testing; Procedure: Respiratory Muscle Training; Other: Supportive Care; Other: Survey Administration |
| Cohort A Arm II (AE) | Experimental | Participants complete tailored intensity AE cycling sessions progressing to over 30 minutes each, 5 days a week, for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call QW to provide support, enhance safety, and promote training compliance on study. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study. Receives: Procedure: Accelerometry; Other: Aerobic Exercise; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Physical Performance Testing; Other: Supportive Care; Other: Survey Administration |
| Cohort A Arm III (AE and RMT education) | Active comparator | Participants receive education on AE and RMT including recommendations aligned with current guidelines 5 days a week for 12 weeks. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study. Receives: Procedure: Accelerometry; Procedure: Biospecimen Collection; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Physical Performance Testing; Other: Survey Administration |
| Cohort B Arm IV (RMT) | Experimental | Participants complete RMT sessions as in arm I for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call QW to provide support, enhance safety, and promote training compliance on study. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study. Receives: Procedure: Accelerometry; Procedure: Biospecimen Collection; Other: Physical Performance Testing; Procedure: Respiratory Muscle Training; Other: Supportive Care; Other: Survey Administration |
| Cohort B Arm V (AE and RMT education) | Active comparator | Participants receive education on AE and RMT as in arm III on study. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study. Receives: Procedure: Accelerometry; Procedure: Biospecimen Collection; Other: Educational Intervention; Other: Physical Performance Testing; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate (Feasibility)
The primary objective is in the feasibility of conducting the respiratory muscle training (RMT) and aerobic exercise (AE) intervention relative to the sham control. In the RMT group, overall compliance (e.g., compliant at all time points) will be estimated using 90% confidence intervals (CIs) obtained Clopper-Pearson method. The lower bounds will define a plausible lower limit for true (unobserved) compliance rates. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors using a generalized estimating equation logistic regression model (autoregressive covariance structure). Estimates of compliance rates will be obtained by time-point and tests about the appropriate contrasts of model estimates will be used to determine if there is a time trend.
Measured: Up to 12 weeks
Adherence rate (Feasibility)
The primary objective is in the feasibility of conducting the RMT and AE intervention relative to the sham control. In the RMT group, overall adherence (complete ≥ 70% of sessions) rates will be estimated using 90% CIs obtained Clopper-Pearson method. The lower bounds will define a plausible lower limit for true (unobserved) adherence rates.
Measured: Up to 12 weeks
Assessing inspiratory and expiratory muscle strength
Participants will complete 3 sets of 15 breaths, 5 days/week using commercially available Power Lung. resistance will be increased 5-10% every week . Participants will rate and log their effort
Measured: At baseline, 6 weeks, and 12 weeks
change in St. George Respiratory Questionnaire (SGRQ)
The SGRQ comprises of 50 items and consists of two parts. Scores range from 0-100, with higher scores indicating worse quality of life.
Measured: At baseline, 6 weeks, and 12 weeks
Functional capacity
Measured by the 6-Minute Walk Test. Will be summarized at pre-, 6-week and post-intervention timepoints, regardless of treatment regimen, using the appropriate descriptive statistics and graphically summarized. The outcome will be analyzed using a linear mixed model, with the intervention arms and time points as predictors. Baseline measurements will be included as a covariate to adjust for initial differences. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point. Comparisons at the 6-week and 3-month follow-up visits will be secondary and will only be performed if the primary comparison for the corresponding endpoint reaches statistical significance. For cohort A, Bonferroni's correction will be applied to adjust for three pairwise comparisons.
Measured: At baseline, 6 weeks, and 12 weeks
Secondary outcomes (7)
Lower extremity strength
Measured using the 30-Second Sit-to-Stand Test. The outcome will be analyzed using a linear mixed model, with the intervention arms and time points as predictors. Baseline measurements will be included as a covariate to adjust for initial differences. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point.
Measured: At baseline and 12 weeks
Physical performance
Measured using the Short Physical Performance Battery. The outcome will be analyzed using a linear mixed model, with the intervention arms and time points as predictors. Baseline measurements will be included as a covariate to adjust for initial differences. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point.
Measured: At baseline and 12 weeks
Physical activity levels
daily step counts and minutes at various intensity levels will be monitored with an activity tracker. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point.
Measured: Up to 12 weeks
Patient-reported outcomes on Fatigue
he Functional Assessment of Chronic Illness Therapy (FACIT- fatigue scale) is a 13-item patient-reported measure of fatigue. Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so". To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. The higher the score, the lower the score the greater the fatigue severity
Measured: At baseline and 12 weeks
High-sensitivity C-reactive protein
The outcome will be analyzed using a linear mixed model, with the intervention arms and time points as predictors. Baseline measurements will be included as a covariate to adjust for initial differences. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point.
Measured: At baseline and 12 weeks
Cardiac biomarkers
Will assess cardiac biomarkers, such as high-sensitivity troponin T and N-terminal pro-brain natriuretic peptide. The outcome will be analyzed using a linear mixed model, with the intervention arms and time points as predictors. Baseline measurements will be included as a covariate to adjust for initial differences. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point. Biomarker data will be appropriately transformed prior to analysis to meet model assumptions.
Measured: At baseline and at 12 weeks
Dyspnea patient reported response
he Dyspnea-12 describes the different qualitative dimensions of breathlessness. Each 12- item (seven for the physical and five for the affective components) score ranges from 'none' (score 0) to 'severe' (score 3) with a total score ranging from 0 to 36 (lower is better), a physical score ranging from 0 to 21 and an affective score ranging from 0 to 15
Measured: Baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew D Ray, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553819
- Sponsor's protocol ID
- I-4565025
- Other IDs
- NCI-2026-01887, I-4565025
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Muscle Training and Aerobic Exercise on Lung Health in Smokers: A Pilot Parallel-Group Study for Lung Cancer Prevention
- ClinicalTrials.gov ID
- NCT07553819
- Acronym / sponsor ID
- I-4565025
- Conditions
- Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies whether home-based respiratory muscle training (RMT) and aerobic exercise (AE) programs can be used to improve lung health in current and former cigarette smokers. Lung cancer, the leading cause of cancer death, is overwhelmingly caused by exposure to cigarette smoke. Research suggests that daily activity reduces lung cancer risk in current and former smokers. However, current and former smokers are generally not active and new approaches to improve lung health are needed. During the home-based RMT program, participants use a handheld device to complete breathing exercise sessions consisting of breathing in and out against adjustable resistance. During the home-based AE program, participants complete aerobic exercises using a stationary bike working at a moderate workload against adjustable resistance. The home-based RMT and AE programs may be effective ways to strengthen the breathing muscles, which may improve lung health in current and former cigarette smokers.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate the feasibility of delivering a home-based AE and RMT program in individuals at high risk for lung cancer.
II. Assess the effects of AE and RMT on patient-reported outcomes (PROs), including QoL, fatigue, dyspnea, performance metrics such as respiratory muscle strength and lower extremity strength; the 6-minute walk test; and daily activity levels in high-risk individuals.
III. Investigate whether RMT and/or AE improve peripheral and exhaled biomarkers associated with lung injury, inflammation, and/or oxidative stress.
OUTLINE: Participants scheduled for a computed tomography (CT) scan are assigned to cohort A, participants who call the New York State Quitline (NYSQL) are assigned to cohort B.
COHORT A: Participants are randomized to 1 of 3 arms.
ARM I: Participants complete RMT sessions via the Power Lung device over 20-30 minutes each consisting of three sets of 15 breaths at a gradual increase in resistance, 5 days a week, for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call once a week (QW) to provide support, enhance safety, and promote training compliance on study.
ARM II: Participants complete tailored intensity AE cycling sessions progressing to over 30 minutes each, 5 days a week, for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call QW to provide support, enhance safety, and promote training compliance on study.
ARM III: Participants receive education on AE and RMT including recommendations aligned with current guidelines 5 days a week for 12 weeks.
COHORT B: Participants are randomized to 1 of 2 arms.
ARM IV: Participants complete RMT sessions as in arm I for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call QW to provide support, enhance safety, and promote training compliance on study.
ARM V: Participants receive education on AE and RMT as in arm III on study.
Additionally, all patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study.
After completion of study intervention, participants may be optionally followed up at week 24.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A Arm I (RMT) | Experimental | Procedure: Accelerometry, Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Physical Performance Testing, Procedure: Respiratory Muscle Training, Other: Supportive Care, Other: Survey AdministrationParticipants complete RMT sessions via the Power Lung device over 20-30 minutes each consisting of three sets of 15 breaths at a gradual increase in resistance, 5 days a week, for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call QW to provide support, enhance safety, and promote training compliance on study. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study. |
| Cohort A Arm II (AE) | Experimental | Procedure: Accelerometry, Other: Aerobic Exercise, Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Physical Performance Testing, Other: Supportive Care, Other: Survey AdministrationParticipants complete tailored intensity AE cycling sessions progressing to over 30 minutes each, 5 days a week, for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call QW to provide support, enhance safety, and promote training compliance on study. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study. |
| Cohort A Arm III (AE and RMT education) | Active comparator | Procedure: Accelerometry, Procedure: Biospecimen Collection, Other: Educational Intervention, Other: Electronic Health Record Review, Other: Physical Performance Testing, Other: Survey AdministrationParticipants receive education on AE and RMT including recommendations aligned with current guidelines 5 days a week for 12 weeks. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study. |
| Cohort B Arm IV (RMT) | Experimental | Procedure: Accelerometry, Procedure: Biospecimen Collection, Other: Physical Performance Testing, Procedure: Respiratory Muscle Training, Other: Supportive Care, Other: Survey AdministrationParticipants complete RMT sessions as in arm I for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call QW to provide support, enhance safety, and promote training compliance on study. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study. |
| Cohort B Arm V (AE and RMT education) | Active comparator | Procedure: Accelerometry, Procedure: Biospecimen Collection, Other: Educational Intervention, Other: Physical Performance Testing, Other: Survey AdministrationParticipants receive education on AE and RMT as in arm III on study. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 50 years old
- Current smoker with a ≥ 20-pack-years history
- Former smoker within the past 15 years, with a history of ≥ 20 pack-years (CT scan cohort only)
- Participant must be able to speak, read and comprehend English language
- Cognitively capable of following direction and performing the intervention
Key exclusion criteria (5 listed)
- Any previous lung cancer diagnoses and or undergoing treatment for any cancer
- Recent pneumonia, bronchitis, or other inflammatory conditions in the lungs, including but limited to chronic obstructive pulmonary disease (COPD) and/or asthma exacerbation within the previous 6 months
- Have uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness/social situations that would limit compliance with study requirements
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccelerometryAncillary studies | Procedure or surgery | Cohort A Arm I (RMT), Cohort A Arm II (AE), Cohort A Arm III (AE and RMT education), Cohort B Arm IV (RMT), Cohort B Arm V (AE and RMT education) |
| Aerobic ExerciseAlso: Aerobic ActivityComplete tailored intensity AE cycling sessions | Other | Cohort A Arm II (AE) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood, nasal swab, exhaled breath, and urine sample collection | Procedure or surgery | Cohort A Arm I (RMT), Cohort A Arm II (AE), Cohort A Arm III (AE and RMT education), Cohort B Arm IV (RMT), Cohort B Arm V (AE and RMT education) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive AE and RMT education | Other | Cohort A Arm III (AE and RMT education), Cohort B Arm V (AE and RMT education) |
| Electronic Health Record ReviewAncillary studies | Other | Cohort A Arm I (RMT), Cohort A Arm II (AE), Cohort A Arm III (AE and RMT education) |
| Physical Performance TestingAlso: Physical Fitness Testing, Physical Function TestingAncillary studies | Other | Cohort A Arm I (RMT), Cohort A Arm II (AE), Cohort A Arm III (AE and RMT education), Cohort B Arm IV (RMT), Cohort B Arm V (AE and RMT education) |
| Respiratory Muscle TrainingAlso: RMTComplete RMT sessions | Procedure or surgery | Cohort A Arm I (RMT), Cohort B Arm IV (RMT) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive virtually supervised session/call | Other | Cohort A Arm I (RMT), Cohort A Arm II (AE), Cohort B Arm IV (RMT) |
| Survey AdministrationAncillary studies | Other | Cohort A Arm I (RMT), Cohort A Arm II (AE), Cohort A Arm III (AE and RMT education), Cohort B Arm IV (RMT), Cohort B Arm V (AE and RMT education) |
Primary outcome
Compliance rate (Feasibility)
Time frame: Up to 12 weeks
The primary objective is in the feasibility of conducting the respiratory muscle training (RMT) and aerobic exercise (AE) intervention relative to the sham control. In the RMT group, overall compliance (e.g., compliant at all time points) will be estimated using 90% confidence intervals (CIs) obtained Clopper-Pearson method. The lower bounds will define a plausible lower limit for true (unobserved) compliance rates. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors using a generalized estimating equation logistic regression model (autoregressive covariance structure). Estimates of compliance rates will be obtained by time-point and tests about the appropriate contrasts of model estimates will be used to determine if there is a time trend.
Adherence rate (Feasibility)
Time frame: Up to 12 weeks
The primary objective is in the feasibility of conducting the RMT and AE intervention relative to the sham control. In the RMT group, overall adherence (complete ≥ 70% of sessions) rates will be estimated using 90% CIs obtained Clopper-Pearson method. The lower bounds will define a plausible lower limit for true (unobserved) adherence rates.
Assessing inspiratory and expiratory muscle strength
Time frame: At baseline, 6 weeks, and 12 weeks
Participants will complete 3 sets of 15 breaths, 5 days/week using commercially available Power Lung. resistance will be increased 5-10% every week . Participants will rate and log their effort
change in St. George Respiratory Questionnaire (SGRQ)
Time frame: At baseline, 6 weeks, and 12 weeks
The SGRQ comprises of 50 items and consists of two parts. Scores range from 0-100, with higher scores indicating worse quality of life.
Functional capacity
Time frame: At baseline, 6 weeks, and 12 weeks
Measured by the 6-Minute Walk Test. Will be summarized at pre-, 6-week and post-intervention timepoints, regardless of treatment regimen, using the appropriate descriptive statistics and graphically summarized. The outcome will be analyzed using a linear mixed model, with the intervention arms and time points as predictors. Baseline measurements will be included as a covariate to adjust for initial differences. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point. Comparisons at the 6-week and 3-month follow-up visits will be secondary and will only be performed if the primary comparison for the corresponding endpoint reaches statistical significance. For cohort A, Bonferroni's correction will be applied to adjust for three pairwise comparisons.
7 secondary outcomes
Lower extremity strength
Time frame: At baseline and 12 weeks
Physical performance
Time frame: At baseline and 12 weeks
Physical activity levels
Time frame: Up to 12 weeks
Patient-reported outcomes on Fatigue
Time frame: At baseline and 12 weeks
High-sensitivity C-reactive protein
Time frame: At baseline and 12 weeks
Cardiac biomarkers
Time frame: At baseline and at 12 weeks
Dyspnea patient reported response
Time frame: Baseline and at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew D Ray principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometry, Aerobic Exercise and Biospecimen Collection in people with Lung Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance rate (Feasibility) (time frame: Up to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.