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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Effects of Comprehensive Postoperative Pulmonary Tele-Rehabilitation in Elderly Patients With Resectable Lung Cancer: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05435885
• Other study ID #: 2205-033-114
• Status: Completed
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: February 16, 2024

Study information

• Verified date: April 2024
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 16, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Cardiopulmonary Exercise Test
• Telerehabilitation

Intervention

Other:
• Pulmonary Tele-Rehabilitation
12 supervised training sessions via a specific mobile messenger during four weeks. (3 sessions/week)
• Control (Education)
Usual care with only one educational session.

Locations

Country	Name	City	State
Korea, Republic of	PusanNUH	Pusan

Sponsors (2)

Lead Sponsor	Collaborator
Pusan National University Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in VO2 peak (peak Oxygen uptake, mL/(kg·min)) on the CardioPulmonary Exercise Test(CPET) after 4 weeks intervention	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.	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Secondary	Change from Baseline in Anaerobic Threshold on the CardioPulmonary Exercise Test(CPET) after 4 weeks intervention.	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.	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Secondary	Maximal Inspiratory Pressure (MIP)	Maximal inspiratory pressure (MIP, cmH2O) is a measure of the strength of inspiratory muscles, primarily the diaphragm.	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Secondary	Skeletal muscle index (SMI)	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.	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Secondary	Hospital Anxiety and Depression Scale (HADS)	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)	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Secondary	EQ-5D (EuroQol-5 dimension)	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.	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Secondary	Grip Strength	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.	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Secondary	Steps	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.	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Secondary	Exercise adherence rate	Exercise adherence is the extent to which a patient acts in accordance with the advised interval, exercise dose, and exercise dosing regimen.	during 4weeks intervention
Secondary	Peak expiratory flow (PEF)	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).	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Secondary	Forced vital capacity (FVC)	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.	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Secondary	The forced expiratory volume in 1 second (FEV1)	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.	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Secondary	Phase angle (PA)	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.	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Secondary	The respiratory exchange ratio (RER)	The respiratory exchange ratio (RER) is the ratio between the metabolic production of carbon dioxide (CO2) and the uptake of oxygen (O2).	Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)