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| Name | Class |
|---|---|
| National Research Foundation of Korea | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-rehabilitation group | Experimental | The Tele-rehabilitation group performs 12 training sessions during four weeks. (3 sessions/week) |
|
| Control group | Other | The control group receives usual care with only one educational session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Tele-Rehabilitation | Other | 12 supervised training sessions via a specific mobile messenger during four weeks. (3 sessions/week) |
|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilatory Efficiency (VE/VCOâ‚‚ Slope) | VE/VCOâ‚‚ slope measured during CPET. Lower values indicate better ventilatory efficiency. | Immediately After Rehabilitation and at 4-Week Follow-Up |
| Maximal Inspiratory Pressure (MIP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Hun Kim, M.D.,Ph.D. | Pusan National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PusanNUH | Pusan | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41294889 | Derived | 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. |
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A total of 96 participants were assessed for eligibility. Of these, 64 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tele-rehabilitation Group | The Tele-rehabilitation group performs 12 training sessions during four weeks. (3 sessions/week) Pulmonary Tele-Rehabilitation: 12 supervised training sessions via a specific mobile messenger during four weeks. (3 sessions/week) |
| FG001 | Control Group | The control group receives usual care with only one educational session. Control (Education): Usual care with only one educational session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tele-rehabilitation Group | The Tele-rehabilitation group performs 12 training sessions during four weeks. (3 sessions/week) Pulmonary Tele-Rehabilitation: 12 supervised training sessions via a specific mobile messenger during four weeks. (3 sessions/week) |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mL/kg/min | Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery) |
|
Through 12 Weeks After Surgery
No adverse events were reported during the study period up to 12 weeks after surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tele-rehabilitation Group | The Tele-rehabilitation group performs 12 training sessions during four weeks. (3 sessions/week) Pulmonary Tele-Rehabilitation: 12 supervised training sessions via a specific mobile messenger during four weeks. (3 sessions/week) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sanghun Kim | Department of Rehabilitation Medicine, Pusan National University Hospital | 82-51-240-7485 | kel5504@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2025 | May 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| Control (Education) | Other | Usual care with only one educational session. |
|
Maximal inspiratory pressure measured using a handheld respiratory device. Higher values indicate stronger inspiratory muscles. Unit of Measure: cmHâ‚‚O
| 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 |
The control group receives usual care with only one educational session. Control (Education): Usual care with only one educational session. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
The control group receives usual care with only one educational session. Control (Education): Usual care with only one educational session. |
|
|
| Secondary | Ventilatory Efficiency (VE/VCOâ‚‚ Slope) | VE/VCOâ‚‚ slope measured during CPET. Lower values indicate better ventilatory efficiency. | Posted | Mean | 95% Confidence Interval | ratio | Immediately After Rehabilitation and at 4-Week Follow-Up |
|
|
|
| Secondary | Maximal Inspiratory Pressure (MIP) | Maximal inspiratory pressure measured using a handheld respiratory device. Higher values indicate stronger inspiratory muscles. Unit of Measure: cmHâ‚‚O | Posted | Mean | 95% Confidence Interval | cm/H2O | Immediately After Rehabilitation and at 4-Week Follow-Up |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | kg/m² | Immediately After Rehabilitation and at 4-Week Follow-Up |
|
|
|
| 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) | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately After Rehabilitation and at 4-Week Follow-Up |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately After Rehabilitation and at 4-Week Follow-Up |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | Kg | Immediately After Rehabilitation and at 4-Week Follow-Up |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | steps/day | Immediately After Rehabilitation and at 4-Week Follow-Up |
|
|
|
| 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). | Posted | Mean | 95% Confidence Interval | L/min | Immediately After Rehabilitation and at 4-Week Follow-Up |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | Liter | Immediately After Rehabilitation and at 4-Week Follow-Up |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | Liter | Immediately After Rehabilitation and at 4-Week Follow-Up |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | degrees | Immediately After Rehabilitation and at 4-Week Follow-Up |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Control Group | The control group receives usual care with only one educational session. Control (Education): Usual care with only one educational session. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Within-Group Differences in HADS Depression Score Immediately After Rehabilitation |
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| Within-Group Differences in HADS Depression Score at 4-Week Follow-Up |
|
| Within-Group Differences in EQ-5D-5L Visual Analog Scale Score Immediately After Rehabilitation |
|
| Within-Group Differences in EQ-5D-5L Visual Analog Scale Score at 4-Week Follow-Up |
|