NCT07646288

Brief Summary

This study aims to evaluate the acute effects of inspiratory muscle training performed with and without a mobile application providing visual feedback on exercise motivation, patient adherence, dyspnea perception, usability, and patient satisfaction in lung cancer patients undergoing lobectomy via video-assisted thoracic surgery. Participants will perform conventional inspiratory muscle training without visual feedback in the morning on postoperative day 1 after transfer to the ward. After at least two hours of rest, the same exercise protocol will be repeated with a smart adaptor connected to a mobile application to provide visual feedback. Inspiratory muscle training will be performed using a threshold-loading device at 40% of maximal inspiratory pressure, with three sets of ten breaths. Outcomes will be assessed before and/or after each session as appropriate.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Dec 2025Mar 2027

Study Start

First participant enrolled

December 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 9, 2026

Last Update Submit

June 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Exercise Motivation

    Exercise motivation will be assessed using the Exercise Motivation Scale after each inspiratory muscle training condition. The scale includes subdomains related to negative attitudes and thoughts, positive perspective and health, and physical appearance and health. Higher scores indicate higher exercise motivation. Scores obtained after conventional inspiratory muscle training and visual feedback-assisted inspiratory muscle training will be compared.

    Immediately after each intervention on postoperative day 1-2.

Secondary Outcomes (5)

  • Dyspnea Perception

    Before and immediately after each intervention on postoperative day 1-2.

  • System Usability

    Immediately after each intervention on postoperative day 1-2.

  • Respiratory Muscle Strength

    Preoperative day, one day before surgery.

  • Patient Satisfaction

    Immediately after each intervention on postoperative day 1-2.

  • Training Performance Data Recorded by the Mobile Application

    During the visual feedback-assisted intervention on postoperative day 1-2.

Study Arms (2)

Conventional IMT Followed by Visual Feedback-Assisted IMT

EXPERIMENTAL

Participants randomized to this arm will first receive conventional inspiratory muscle training without visual feedback. After a rest period of at least two hours, they will receive visual feedback-assisted inspiratory muscle training using a smart adaptor connected to a mobile application. Both training sessions will be performed using a threshold-loading inspiratory muscle training device at 40% of maximal inspiratory pressure, with three sets of ten breaths.

Other: Conventional Inspiratory Muscle TrainingOther: Visual Feedback-Assisted Inspiratory Muscle Training

Visual Feedback-Assisted IMT Followed by Conventional IMT

EXPERIMENTAL

Participants randomized to this arm will first receive visual feedback-assisted inspiratory muscle training using a smart adaptor connected to a mobile application. After a rest period of at least two hours, they will receive conventional inspiratory muscle training without visual feedback. Both training sessions will be performed using a threshold-loading inspiratory muscle training device at 40% of maximal inspiratory pressure, with three sets of ten breaths.

Other: Conventional Inspiratory Muscle TrainingOther: Visual Feedback-Assisted Inspiratory Muscle Training

Interventions

Visual feedback-assisted inspiratory muscle training will be performed using a threshold-loading inspiratory muscle training device connected to a smart adaptor and mobile application. The mobile application will provide visual feedback during training. Training will be performed at 40% of maximal inspiratory pressure, with three sets of ten breaths. Application-derived data, including the number of successful breaths, total training duration, and total number of breaths, will be recorded.

Conventional IMT Followed by Visual Feedback-Assisted IMTVisual Feedback-Assisted IMT Followed by Conventional IMT

Conventional inspiratory muscle training will be performed without visual feedback or mobile application support. Training will be delivered using a threshold-loading inspiratory muscle training device at 40% of maximal inspiratory pressure, with three sets of ten breaths.

Conventional IMT Followed by Visual Feedback-Assisted IMTVisual Feedback-Assisted IMT Followed by Conventional IMT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the study,
  • Being clinically stable,
  • Being a lung cancer patient scheduled for lobectomy,
  • Being between 18 and 75 years of age,
  • Being able to cooperate with the tests to be performed.

You may not qualify if:

  • Presence of any orthopedic or neurological problem that prevents walking,
  • History of any surgery involving the thoracic wall,
  • Having diseases that may affect respiratory parameters, such as severe heart failure or severe chronic obstructive pulmonary disease (COPD).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Participants will receive both conventional inspiratory muscle training and visual feedback-assisted inspiratory muscle training in a randomized crossover design. The order of the two interventions will be randomized, with at least two hours of rest between sessions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC, PhD (c)

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 12, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

June 12, 2026

Record last verified: 2026-06

Locations