Exercise Prehabilitation for Patients With NSCLC Before Surgery

NCT05608759 | Completed DMC

• 1 other identifier: TJ-IRB20220564
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the safety and compliance of a wearable telemedicine device that can receive basic vital signs in real time, and its active supervision mode with real-time adjustment of exercise prescription for preoperative prehabilitation exercises in patients at home; and to evaluate the effectiveness of preoperative prehabilitation exercises in a telemedicine active supervision mode in patients undergoing thoracoscopic lung tumour resection, taking into account the patient's cardiopulmonary exercise test, postoperative complications and quality of life scores.

Conditions

Prehabilitation; Non Small Cell Lung Cancer; Cardiorespiratory Fitness; Surgery

Keywords

Prehabilitation; Cardiorespiratory fitness; Non-small cell lung cancer; Exercise; Wearable technology; Surgery

Outcome Measures

Primary Outcomes (1)

• Study feasibility

  Assessed by the following indicators: study participation rate, screening and enrollment rates, intervention completion rate, number of completed exercise days, wearable-device wearing days and wearing rate, analyzable activity days, paper-log completion, app-based electronic-log completion, alert generation and closure, intervention discontinuation, adverse events, and serious adverse events

  Baseline, 4 weeks after prehabilitation exercise

Secondary Outcomes (6)

• Pre-post changes in cardiopulmonary exercise testing

  Baseline, 4 weeks of prehabilitation exercise

• Forced expiratory volume in 1 s(FEV1)

  Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery

• Forced vital capacity (FVC)

  Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery

• Change in quality of life

  Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery

• Post-operative complications

  30-days after surgery (T4)

Study Arms (1)

single arm

EXPERIMENTAL

4 weeks of multimodal pre-rehabilitation

Behavioral: Multimodal prehabilitation

Interventions

Multimodal prehabilitation BEHAVIORAL

4 weeks of an supervised, pre-operative exercise prescription augmented by a wearable fitness device.

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capacity to give informed consent.
• Are able to tolerate surgery (i.e., segmentectomy, lobectomy) as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiopulmonary exercise testing.
• Patients who can use a smartphone application.
• Patients who are diagnosed of stage I or II Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation.
• Patients who can perform an exercise program for at least 4 weeks from the first visit to the preoperative clinic to elective surgery.

You may not qualify if:

• Known contraindication for cardiopulmonary exercise testing.
• Patients who have a major medical or psychiatric disorder that is expected to affect exercise.
• Pregnancy or lactating women.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• Sun Q, Omindo WW, Liu W, Huang Y, Zhang R, Qian Y, Li X, Qiu R, Zheng S, Ping W, Zhang N. Your preoperative rehabilitation assistant: A study protocol for the impact of a telemedicine-supported preoperative home rehabilitation program on the prognosis of patients undergoing thoracoscopic surgery. Digit Health. 2024 Jun 5;10:20552076241258362. doi: 10.1177/20552076241258362. eCollection 2024 Jan-Dec.

  PMID: 39351312 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Motor Activity

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 8, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 28, 2025
• Last Updated: June 16, 2026

Record last verified: 2025-12

Locations

CN (1)