TelerehabilitationNCT05435885
Postoperative Telerehabilitation in Older Adults
A study testing Pulmonary Tele-Rehabilitation in people with Telerehabilitation and Carcinoma, Non-Small-Cell Lung, run by Pusan National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Telerehabilitation, Carcinoma, Non-Small-Cell Lung, Cardiopulmonary Exercise Test
- What is being tested?
- Pulmonary Tele-Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jul 2022to 16 Feb 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- A person who is suspected of lung cancer and is scheduled to undergo a thoracoscopic lung resection surgery.
- men and women the age ≥65 years.
- A person who understands the course of the clinical trial and signs the informed consent form.
Who cannot join
- Patients whose activity is restricted due to other diseases (e.g. osteoarthritis, spinal disease, cerebral infarction, etc.)
- Patients who cannot test bioimpedance analysis due to the insertion of artificial pacemakers and defibrillators
- A person who has difficulty judging himself/herself due to dementia, etc
- Those enrolled in other clinical trials
- A person deemed inappropriate to participate in this clinical trial under the judgement of the investigator.
- A person who cannot use mobile messenger
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This randomized controlled trial aims to evaluate the effectiveness of a mobile messenger-based home pulmonary telerehabilitation protocol in patients undergoing lung lobectomy. All participants receive standard perioperative rehabilitation and education. The intervention group receives additional customized exercise instructions and real-time support via KakaoTalk for 4 weeks, including aerobic, resistance, and breathing exercises. The control group receives one-time education without remote monitoring. Primary outcome is VO₂peak; secondary outcomes include respiratory function, muscle strength, body composition, quality of life, and exercise adherence.
- Being tested
- Pulmonary Tele-Rehabilitation, Control (Education)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Tele-RehabilitationOther
12 supervised training sessions via a specific mobile messenger during four weeks. (3 sessions/week)
Control (Education)Other
Usual care with only one educational session.
| Study group | Role | What they receive |
|---|---|---|
| Tele-rehabilitation group | Experimental | The Tele-rehabilitation group performs 12 training sessions during four weeks. (3 sessions/week) Receives: Other: Pulmonary Tele-Rehabilitation |
| Control group | Other | The control group receives usual care with only one educational session. Receives: Other: Control (Education) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Secondary outcomes (11)
Ventilatory Efficiency (VE/VCO₂ Slope)
VE/VCO₂ slope measured during CPET. Lower values indicate better ventilatory efficiency.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately After Rehabilitation and at 4-Week Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start25 Jul 2022
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Sponsor
- Investigators
- Sang Hun Kim, M.D.,Ph.D., Study director, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435885
- Sponsor's protocol ID
- 2205-033-114
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2022
- Last updated
- 8 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shin YB, Huh S, Cho JS, Hong CH, Kim Y, Shin MJ, Yun RY, Lee J, Son BS, Kim SH. Comparison of Postoperative Telerehabilitation and Unsupervised Home-Based Training in Older Adults With Lung Cancer: A Randomized Controlled Trial. J Cardiopulm Rehabil Prev. 2026 Mar 1;46(2):132-139. doi: 10.1097/HCR.0000000000000988. Epub 2025 Nov 26.
PubMed 41294889