Inspiratory Muscle Training and Behavioral Support to Alleviate Dyspnea and Promote Walking in Lung Cancer Survivors: A Pilot Study

Lung Neoplasm Clinical Trial

Official title:

Tele-rehabilitation Following Curative Intent Therapy of Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05059132
• Other study ID #: LCD-820773
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms

Intervention

Behavioral:
• Tele-rehabilitation
The tele-rehabilitation intervention will include education, inspiratory muscle training, and behavioral support to promote walking.

Other:
• Education only
The education only arm will receive information on the importance of general exercise following lung cancer treatment.

Locations

Country	Name	City	State
United States	Kaiser Permanente Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	American Lung Association

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ha 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 ther — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in change in accelerometry-measured physical activity between baseline and week 12	Physical activity will be measured by the activPAL4 device (PAL Technologies, Ltd).	Baseline, mid study (week 6), and end of study (week 12).
Secondary	Difference in change in functional capacity between baseline and week 12	Functional capacity will be measured using the mobile six-minute walk test.	Baseline, mid study (week 6), and end of study (week 12)
Secondary	Difference in change in self-reported physical activity between baseline and week 12	Self-reported physical activity will be measured using the International Physical Activity Questionnaire - Short Form	Baseline, mid study (week 6), and end of study (week 12)
Secondary	Difference in change in control of dyspnea between baseline and week 12	Dyspnea control will be measured using the the University of California, San Diego Shortness of Breath Questionnaire.	Baseline, mid study (week 6), and end of study (week 12)
Secondary	Difference in change in anxiety symptoms between baseline and week 12	Anxiety symptoms will be measured using the General Anxiety Disorder-7	Baseline, mid study (week 6), and end of study (week 12)
Secondary	Difference in change in sleep quality between baseline and week 12	Sleep quality will be measured using the Pittsburgh Sleep Quality Index	Baseline, mid study (week 6), and end of study (week 12)
Secondary	Difference in change in quality of life between baseline and week 12	Quality of life will be measured using the St. George's Respiratory Questionnaire	Baseline, mid study (week 6), and end of study (week 12)