Clinical trial · Interventional
Inspiratory Muscle Training and Behavioral Support to Alleviate Dyspnea and Promote Walking in Lung Cancer Survivors: A Pilot Study
Tele-rehabilitation Following Curative Intent Therapy of Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a pilot randomized study to investigate the feasibility, acceptability, safety, and effects of a novel tele-rehabilitation intervention for stage I-IIIA lung cancer survivors following curative intent therapy. The specific aims and hypotheses are: Specific Aim 1: Conduct a pilot, phase IIb, parallel randomized (1:1) study to investigate the feasibility, acceptability, and safety of inspiratory muscle training and behavioral support to promote walking in tele-rehabilitation with stage I-IIIA lung cancer survivors following curative intent therapy (N=40). Hypothesis 1a: ≥ 20% eligible patients will enroll; ≥75% of participants will achieve ≥75% adherence to the tele-rehabilitation program. Hypothesis 1b: ≥75% of participants will perceive tele-rehabilitation as acceptable (Telemedicine Satisfaction and Usefulness Questionnaire ≥4). There will be 0 intervention adverse events. Specific Aim 2: Explore the effects of the tele-rehabilitation program (N=40). Hypothesis 2: At 12 weeks, participants in the tele-rehabilitation (experimental) arm, compared to education only (control) arm, will have a trend of greater improvements in outcomes, including: 1. accelerometry-measured physical activity (primary outcome); and 2. functional capacity, self-reported physical activity, control of dyspnea and anxiety symptoms, sleep quality, and quality of life (secondary outcomes).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Education only | Other | — | UNRESOLVED |
| Tele-rehabilitation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tele-rehabilitation
- description
- Participants in the tele-rehabilitation arm will receive a home-based, remotely delivered rehabilitation program.
- interventionNames
- Behavioral: Tele-rehabilitation
- type
- ACTIVE_COMPARATOR
- label
- Education only
- description
- Participants in the education arm will receive educational materials only, delivered through telecommunication messages.
- interventionNames
- Other: Education only
Primary outcomes (1)
- measure
- Difference in change in accelerometry-measured physical activity between baseline and week 12
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * history of stage I-IIIA lung cancer; * completed curative intent therapy (i.e., lung cancer resection surgery, definitive radiation, or concurrent chemoradiation) within 1-6 months; * access to a mobile phone or personal computer with internet access; * willingness to wear activity trackers Exclusion Criteria: * dementia (or cognitive impairment identified by chart review) resulting in inability to follow directions or provide written informed consent; * acute myocardial infarction, ventricular tachycardia, ventricular fibrillation, acute cerebrovascular event, or acute asthma exacerbation in past 2 months; * spontaneous pneumothorax in past 12 months; * Parkinson's disease; * multiple sclerosis; * amyotrophic lateral sclerosis; * additional movement/gait disorders that may be identified by chart review
References
Publications (1)
- RESULTHa DM, Comer A, Dollar B, Bedoy R, Ford M, Gozansky WS, Zeng C, Arch JJ, Leach HJ, Malhotra A, Prochazka AV, Keith RL, Boxer RS. Telemedicine-based inspiratory muscle training and walking promotion with lung cancer survivors following curative intent therapy: a parallel-group pilot randomized trial. Support Care Cancer. 2023 Sep 1;31(9):546. doi: 10.1007/s00520-023-07999-7. PMID 37656252