Telemedicine-based inspiratory muscle training and walking promotion with lung cancer survivors following curative intent therapy: a parallel-group pilot randomized trial

Duc M Ha, Angela Comer, Blythe Dollar, Ruth Bedoy, Morgan Ford, Wendolyn S Gozansky, Chan Zeng, Joanna J Arch, Heather J Leach, Atul Malhotra, Allan V Prochazka, Robert L Keith, Rebecca S Boxer, Duc M Ha, Angela Comer, Blythe Dollar, Ruth Bedoy, Morgan Ford, Wendolyn S Gozansky, Chan Zeng, Joanna J Arch, Heather J Leach, Atul Malhotra, Allan V Prochazka, Robert L Keith, Rebecca S Boxer

Abstract

Purpose: Following curative-intent therapy of lung cancer, many survivors experience dyspnea and physical inactivity. We investigated the feasibility, acceptability, safety, and potential efficacy of inspiratory muscle training (IMT) and walking promotion to disrupt a postulated "dyspnea-inactivity" spiral.

Methods: Between January and December 2022, we recruited lung cancer survivors from Kaiser Permanente Colorado who completed curative-intent therapy within 1-6 months into a phase-IIb, parallel-group, pilot randomized trial (1:1 allocation). The 12-week intervention, delivered via telemedicine, consisted of exercise training (IMT + walking), education, and behavior change support. Control participants received educational materials on general exercise. We determined feasibility a priori: enrollment of ≥ 20% eligible patients, ≥ 75% retention, study measure completion, and adherence. We assessed acceptability using the Telemedicine-Satisfaction-and-Usefulness-Questionnaire and safety events that included emergency department visits or hospitalizations. Patient-centered outcome measures (PCOMs) included dyspnea (University-of-California-San-Diego-Shortness-of-Breath-Questionnaire), physical activity (activPAL™ steps/day), functional exercise capacity (mobile-based-six-minute-walk-test), and health-related quality of life (HRQL, St.-George's-Respiratory-Questionnaire). We used linear mixed-effects models to assess potential efficacy.

Results: We screened 751 patients, identified 124 eligible, and consented 31 (25%) participants. Among 28 participants randomized (14/group), 22 (11/group) completed the study (79% retention). Intervention participants returned > 90% of self-reported activity logs, completed > 90% of PCOMs, and attended > 90% of tele-visits; 75% of participants performed IMT at the recommended dose. Participants had high satisfaction with tele-visits and found the intervention useful. There was no statistically significant difference in safety events between groups. Compared to control participants from baseline to follow-up, intervention participants had statistically significant and clinically meaningful improved HRQL (SGRQ total, symptom, and impact scores) (standardized effect size: -1.03 to -1.30).

Conclusions: Among lung cancer survivors following curative-intent therapy, telemedicine-based IMT + walking was feasible, acceptable, safe, and had potential to disrupt the "dyspnea-inactivity" spiral. Future efficacy/effectiveness trials are warranted and should incorporate IMT and walking promotion to improve HRQL.

Trial registration: ClinicalTrials.gov NCT05059132.

Keywords: Dyspnea; Exercise; Patient-centered outcomes; Rehabilitation; Survivorship; Telemedicine; Telerehabilitation.

Conflict of interest statement

The authors declare no competing interests.

All authors declare that no conflict of interest exists. Dr. Malhotra is funded by NIH. He reports income related to medical education from Jazz, Zoll, Eli Lilly and Livanova. ResMed provided a philanthropic donation to the University of California San Diego.

© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.

Figures

Fig. 1
Fig. 1
Consort Diagram. *Including one participant who completed but did not return the activPAL device. KPCO = Kaiser Permanente Colorado
Fig. 2
Fig. 2
Conceptual Model of the Vicious Cycle of “Dyspnea-Inactivity” Downward Health Spiral Following Curative Intent Therapy of Lung Cancer. Bolded text indicates a vicious cycle of “dyspnea-inactivity.” Description [4]: Following diagnosis and curative intent therapy of lung cancer, survivors experience increased symptom burden, particularly with dyspnea due to loss of lung tissue and function, lost or damaged nerve fibers and peripheral sensors, and alterations to the neuro-respiratory system, culminating in neuromechanical dissociation and increased central ‘corollary discharge’. Consequently, many survivors avoid physical activity and exercise [17, 18], leading to a vicious cycle of “dyspnea-inactivity.” Over time, combined with worry or fear of lung cancer recurrence [73], sleep disturbance [71], fatigue [71], the adopted physical inactivity leads to deconditioning [74], impaired functional exercise capacity [75], social isolation [76], anxiety and depressive symptoms, resulting in physical and psychosocial disability [77]. This downward health spiral can go unrecognized and negatively impact HRQL. Interventions should promptly disrupt this downward health spiral and reduce symptom burden, increase physical activity, social engagement, and promote behavior change to improve HRQL and other outcomes. HRQL = health-related quality of life

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