Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers

Официальное название

Effects of Respiratory Muscle Training and Aerobic Exercise on Lung Health in Smokers: A Pilot Parallel-Group Study for Lung Cancer Prevention

Обзор

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.

Подробное описание

PRIMARY OBJECTIVES:

I. 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.

Вмешательства

• Процедура Accelerometry
  Ancillary studies
• Другое Aerobic Exercise
  Complete tailored intensity AE cycling sessions
• Процедура Biospecimen Collection
  Undergo blood, nasal swab, exhaled breath, and urine sample collection
• Другое Educational Intervention
  Receive AE and RMT education
• Другое Electronic Health Record Review
  Ancillary studies
• Другое Physical Performance Testing
  Ancillary studies
• Процедура Respiratory Muscle Training
  Complete RMT sessions
• Другое Supportive Care
  Receive virtually supervised session/call
• Другое Survey Administration
  Ancillary studies

Первичные конечные точки

• Compliance rate (Feasibility) [Срок оценки: Up to 12 weeks]
• Adherence rate (Feasibility) [Срок оценки: Up to 12 weeks]
• Assessing inspiratory and expiratory muscle strength [Срок оценки: At baseline, 6 weeks, and 12 weeks]
• change in St. George Respiratory Questionnaire (SGRQ) [Срок оценки: At baseline, 6 weeks, and 12 weeks]
• Functional capacity [Срок оценки: At baseline, 6 weeks, and 12 weeks]

Вторичные конечные точки (7)

• Lower extremity strength [Срок оценки: At baseline and 12 weeks]
• Physical performance [Срок оценки: At baseline and 12 weeks]
• Physical activity levels [Срок оценки: Up to 12 weeks]
• Patient-reported outcomes on Fatigue [Срок оценки: At baseline and 12 weeks]
• High-sensitivity C-reactive protein [Срок оценки: At baseline and 12 weeks]
• Cardiac biomarkers [Срок оценки: At baseline and at 12 weeks]
• Dyspnea patient reported response [Срок оценки: Baseline and at 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Roswell Park Cancer Institute — Buffalo

Идентификаторы

NCT: NCT07553819 · I-4565025 · NCI-2026-01887 · I-4565025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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