Effects of Comprehensive Postoperative Pulmonary Tele-Rehabilitation in Elderly Patients With Resectable Lung Cancer

Not Applicable

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung; Telerehabilitation; Cardiopulmonary Exercise Test
• Interventions: Other: Pulmonary Tele-Rehabilitation; Other: Control (Education)

• Registration Number: NCT05435885
• Lead Sponsor: Pusan National University Hospital

Brief Summary

The purpose of this study is to confirm the effectiveness of a mobile messenger-based home tele-rehabilitation protocol in patients who have undergone lung resection surgery.

By analyzing the difference from the existing postoperative pulmonary rehabilitation, the investigators would like to propose a new pulmonary tele-rehabilitation protocol.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-28
• Study Start: 2022-07-25
• Primary Completion: 2024-02-16
• Study Completion: 2024-02-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-13
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. A person who is suspected of lung cancer and is scheduled to undergo a thoracoscopic lung resection surgery.
2. men and women the age ≥65 years.
3. A person who understands the course of the clinical trial and signs the informed consent form.

Exclusion Criteria

1. Patients whose activity is restricted due to other diseases (e.g. osteoarthritis, spinal disease, cerebral infarction, etc.)
2. Patients who cannot test bioimpedance analysis due to the insertion of artificial pacemakers and defibrillators
3. A person who has difficulty judging himself/herself due to dementia, etc
4. Those enrolled in other clinical trials
5. A person deemed inappropriate to participate in this clinical trial under the judgement of the investigator.
6. A person who cannot use mobile messenger

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tele-rehabilitation group	Pulmonary Tele-Rehabilitation	The Tele-rehabilitation group performs 12 training sessions during four weeks. (3 sessions/week)
Control group	Control (Education)	The control group receives usual care with only one educational session.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in VO2 peak (peak Oxygen uptake, mL/(kg·min)) on the CardioPulmonary Exercise Test(CPET) after 4 weeks intervention	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)	Cardiopulmonary exercise test (CPET) also referred to as a VO2 (oxygen consumption) test, is a specialized type of stress test or exercise test that measures participants exercise ability.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Anaerobic Threshold on the CardioPulmonary Exercise Test(CPET) after 4 weeks intervention.	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)	The anaerobic threshold is the lowest intensity of exercise at which the production of lactate exceeds the body's ability to utilize lactate as fuel in aerobic metabolism.
Maximal Inspiratory Pressure (MIP)	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)	Maximal inspiratory pressure (MIP, cmH2O) is a measure of the strength of inspiratory muscles, primarily the diaphragm.
Skeletal muscle index (SMI)	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)	Skeletal muscle mass index (SMI, kg/m2) was calculated by dividing the limb skeletal muscle mass (kg) by the square of the height (m2) using bioimpedance analysis.
Grip Strength	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)	Grip strength is a measure of muscular strength or the maximum force/tension generated by participant's forearm muscles using the Jamar Hydraulic Hand Dynamometer.; The force has been measured in kilograms.
The respiratory exchange ratio (RER)	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)	The respiratory exchange ratio (RER) is the ratio between the metabolic production of carbon dioxide (CO2) and the uptake of oxygen (O2).
Steps	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)	As a physical activity, Counting participant's steps per a day with an activity tracker.; Average number of steps per day for one week before surgery and after discharge.
The forced expiratory volume in 1 second (FEV1)	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)	The forced expiratory volume in 1 second (FEV1) is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.
EQ-5D (EuroQol-5 dimension)	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)	EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys.; EQ-5D instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS).; The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.; Each dimension has 5 levels: no problems(1) slight problems(2) moderate problems(3) severe problems(4) extreme problems(5); EQ VAS is numbered from 0 to 100. 100 means the best health the participant can imagine. 0 means the worst health the participant can imagine.
Peak expiratory flow (PEF)	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)	The peak expiratory flow (PEF) is a participant's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a participant's ability to breathe out air. It measures the airflow through the bronchi and thus the degree of obstruction in the airways. Peak expiratory flow is typically measured in units of liters per minute (L/min).
Phase angle (PA)	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)	Bioelectrical impedance analysis (BIA)-derived phase angle (PA) is an alternative method to assess mortality risk. BIA is a simple, non-invasive technique that estimates body composition by measuring the opposition (impedance) to an applied current while passing through the body. Impedance consists of two components: resistance, which is the opposition to the flow of an alternating current through intra- and extracellular ionic solutions, and reactance, which is the delay in conduction as a result of capacitance by cell membranes and tissue interfaces.; PA is regarded as a biological marker of cellular health, as it reflects cell mass, membrane integrity, and hydration status. PA has repeatedly proven to be a predictor of morbidity and mortality in various patient groups.
Hospital Anxiety and Depression Scale (HADS)	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)	The Hospital Anxiety and Depression Scale (HADS) was devised 30 years ago by Zigmond and Snaith to measure anxiety and depression in a general medical population of patients.; The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression.; Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.; 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Exercise adherence rate	during 4weeks intervention	Exercise adherence is the extent to which a patient acts in accordance with the advised interval, exercise dose, and exercise dosing regimen.
Forced vital capacity (FVC)	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)	Forced vital capacity (FVC) is the maximum amount of air a participant can forcibly exhale from lungs after fully inhaling.; The unit is expressed in liters.

Trial Locations

Locations (1)

PusanNUH; 🇰🇷 Pusan, Korea, Republic of