Exercise Prehabilitation for Patients With NSCLC Before Surgery

NCT ID: NCT05608759

Last Updated: 2023-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prehabilitation Non Small Cell Lung Cancer Cardiorespiratory Fitness Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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single arm

4 weeks of multimodal pre-rehabilitation

Group Type EXPERIMENTAL

Multimodal prehabilitation

Intervention Type BEHAVIORAL

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

Interventions

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Multimodal prehabilitation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Capacity to give informed consent.
2. 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.
3. Patients who can use a smartphone application.
4. Patients who are diagnosed of stage I or II Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation.
5. Patients who can perform an exercise program for at least 4 weeks from the first visit to the preoperative clinic to elective surgery.

Exclusion Criteria

1. Known contraindication for cardiopulmonary exercise testing.
2. Patients who have a major medical or psychiatric disorder that is expected to affect exercise.
3. Pregnancy or lactating women.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhang Ni

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ni Zhang, Doctor

Role: CONTACT

+8613006315393

Biyun Zhou, Doctor

Role: CONTACT

+8613517275908

Facility Contacts

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Wei Ping, Doctor

Role: primary

+8613437101581

References

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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.

Reference Type DERIVED
PMID: 39351312 (View on PubMed)

Other Identifiers

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TJ-IRB20220564

Identifier Type: -

Identifier Source: org_study_id

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