NCT05608759

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

October 27, 2022

Last Update Submit

June 11, 2023

Conditions

PrehabilitationNon Small Cell Lung CancerCardiorespiratory FitnessSurgery

Keywords

PrehabilitationCardiorespiratory fitnessNon-small cell lung cancerExerciseWearable technologySurgery

Outcome Measures

Primary Outcomes (1)

  • Exercise capacity

    Exercise testing on a cycloergometer(VO2 max)

    Baseline, 4 weeks after prehabilitation exercise

Secondary Outcomes (8)

  • 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

  • Acceptance of technology

    4 weeks of prehabilitation exercise

  • Change in quality of life

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

  • Change in grip-strength

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

  • +3 more secondary outcomes

Study Arms (1)

single arm

EXPERIMENTAL

4 weeks of multimodal pre-rehabilitation

Behavioral: Multimodal prehabilitation

Interventions

Multimodal prehabilitationBEHAVIORAL

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

single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

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: 39351312DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungMotor Activity

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Central Study Contacts

Ni Zhang, Doctor

CONTACT

+8613006315393zhangnidoc@163.com

Biyun Zhou, Doctor

CONTACT

+8613517275908biyun.zz@gmail.com

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, 2023

Study Completion

March 31, 2024

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

CN(1)