Postoperative Telerehabilitation in Older Adults

Comparison of Postoperative Telerehabilitation and Unsupervised Home-Based Training in Older Adults With Lung Cancer: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung; Telerehabilitation; Cardiopulmonary Exercise Test
• Intervention / Treatment: Other: Pulmonary Tele-Rehabilitation; Other: Control (Education)

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Pusan, Korea, Republic of
    • PusanNUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-rehabilitation group; The Tele-rehabilitation group performs 12 training sessions during four weeks. (3 sessions/week)	Other: Pulmonary Tele-Rehabilitation; 12 supervised training sessions via a specific mobile messenger during four weeks. (3 sessions/week)
Other: Control group; The control group receives usual care with only one educational session.	Other: Control (Education); Usual care with only one educational session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilatory Efficiency (VE/VCO₂ Slope)	VE/VCO₂ slope measured during CPET. Lower values indicate better ventilatory efficiency.	Immediately After Rehabilitation and at 4-Week Follow-Up
Maximal Inspiratory Pressure (MIP)	Maximal inspiratory pressure measured using a handheld respiratory device. Higher values indicate stronger inspiratory muscles. Unit of Measure: cmH₂O	Immediately After Rehabilitation and at 4-Week Follow-Up
Skeletal Muscle Index (SMI)	Skeletal muscle index calculated by dividing appendicular skeletal muscle mass by height squared. Higher values indicate greater muscle mass. Unit of Measure: kg/m²	Immediately After Rehabilitation and at 4-Week Follow-Up
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)	Immediately After Rehabilitation and at 4-Week Follow-Up
EQ-5D (EuroQol-5 Dimension)	The EQ-5D-5L is a standardized instrument developed by the EuroQol Group to measure health-related quality of life. It consists of two parts: a descriptive system 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 five levels: (1) no problems, (2) slight problems, (3) moderate problems, (4) severe problems, and (5) extreme problems. Responses are converted into a summary index score, which ranges from -0.281 to 1.000, based on country-specific value sets. Higher index scores indicate better health status, with 1.000 representing full health and values below 0 indicating health states considered worse than death. The EQ VAS records the participant's self-rated health on a vertical visual analogue scale ranging from 0 to 100, where 100 represents the best health imaginable and 0 represents the worst health imaginable. Higher VAS scores reflect	Immediately After Rehabilitation and at 4-Week Follow-Up
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.	Immediately After Rehabilitation and at 4-Week Follow-Up
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.	Immediately After Rehabilitation and at 4-Week Follow-Up
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).	Immediately After Rehabilitation and at 4-Week Follow-Up
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.	Immediately After Rehabilitation and at 4-Week Follow-Up
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.	Immediately After Rehabilitation and at 4-Week Follow-Up
Whole-Body Phase Angle	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.	Immediately After Rehabilitation and at 4-Week Follow-Up

Collaborators and Investigators

• Sponsor: Pusan National University Hospital
• Collaborators: National Research Foundation of Korea
• Investigators: Study Director: Sang Hun Kim, M.D.,Ph.D., Pusan National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): February 16, 2024
• Study Completion (Actual): February 16, 2024

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2205-033-114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No