Trial Outcomes & Findings for Postoperative Telerehabilitation in Older Adults (NCT NCT05435885)
NCT ID: NCT05435885
Last Updated: 2025-06-17
Results Overview
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.
COMPLETED
NA
64 participants
Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
2025-06-17
Participant Flow
A total of 96 participants were assessed for eligibility. Of these, 64 were randomized.
Participant milestones
| Measure |
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)
|
Control Group
The control group receives usual care with only one educational session.
Control (Education): Usual care with only one educational session.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
35
|
|
Overall Study
COMPLETED
|
26
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tele-rehabilitation Group
n=29 Participants
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)
|
Control Group
n=35 Participants
The control group receives usual care with only one educational session.
Control (Education): Usual care with only one educational session.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=29 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=64 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=29 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=64 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=29 Participants
|
35 Participants
n=35 Participants
|
64 Participants
n=64 Participants
|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 5 • n=29 Participants
|
72.2 years
STANDARD_DEVIATION 5 • n=35 Participants
|
71.9 years
STANDARD_DEVIATION 5 • n=64 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=29 Participants
|
14 Participants
n=35 Participants
|
28 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=29 Participants
|
21 Participants
n=35 Participants
|
36 Participants
n=64 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Korea
|
29 participants
n=29 Participants
|
35 participants
n=35 Participants
|
64 participants
n=64 Participants
|
|
BMI
|
24 kg/m2
STANDARD_DEVIATION 3 • n=29 Participants
|
24 kg/m2
STANDARD_DEVIATION 4 • n=35 Participants
|
24 kg/m2
STANDARD_DEVIATION 3 • n=64 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Tele-rehabilitation Group
n=29 Participants
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)
|
Control Group
n=35 Participants
The control group receives usual care with only one educational session.
Control (Education): Usual care with only one educational session.
|
|---|---|---|
|
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)
|
23.67 mL/kg/min
Standard Deviation 4.64
|
23.09 mL/kg/min
Standard Deviation 4.73
|
|
Change From Baseline in VO2 Peak (Peak Oxygen Uptake, mL/kg/Min) on the CardioPulmonary Exercise Test(CPET) After 4 Weeks Intervention
Baseline (4 weeks after surgery)
|
19.28 mL/kg/min
Standard Deviation 4.16
|
20.41 mL/kg/min
Standard Deviation 3.62
|
|
Change From Baseline in VO2 Peak (Peak Oxygen Uptake, mL/kg/Min) on the CardioPulmonary Exercise Test(CPET) After 4 Weeks Intervention
After intervention(8 weeks after surgery)
|
21.85 mL/kg/min
Standard Deviation 4.22
|
19.85 mL/kg/min
Standard Deviation 4.02
|
|
Change From Baseline in VO2 Peak (Peak Oxygen Uptake, mL/kg/Min) on the CardioPulmonary Exercise Test(CPET) After 4 Weeks Intervention
Follow up(12 weeks after surgery)
|
21.73 mL/kg/min
Standard Deviation 4.18
|
19.82 mL/kg/min
Standard Deviation 3.89
|
SECONDARY outcome
Timeframe: Immediately After Rehabilitation and at 4-Week Follow-UpVE/VCO₂ slope measured during CPET. Lower values indicate better ventilatory efficiency.
Outcome measures
| Measure |
Tele-rehabilitation Group
n=29 Participants
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)
|
Control Group
n=35 Participants
The control group receives usual care with only one educational session.
Control (Education): Usual care with only one educational session.
|
|---|---|---|
|
Ventilatory Efficiency (VE/VCO₂ Slope)
Within-Group Differences in VE/VCO₂ Slope Immediately After Rehabilitation
|
4.0 ratio
Interval 1.1 to 6.9
|
0.6 ratio
Interval -3.0 to 4.2
|
|
Ventilatory Efficiency (VE/VCO₂ Slope)
Within-Group Differences in VE/VCO₂ Slope at 4-Week Follow-Up
|
-0.1 ratio
Interval -2.5 to 2.4
|
1.4 ratio
Interval -1.4 to 4.2
|
SECONDARY outcome
Timeframe: Immediately After Rehabilitation and at 4-Week Follow-UpMaximal inspiratory pressure measured using a handheld respiratory device. Higher values indicate stronger inspiratory muscles. Unit of Measure: cmH₂O
Outcome measures
| Measure |
Tele-rehabilitation Group
n=29 Participants
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)
|
Control Group
n=35 Participants
The control group receives usual care with only one educational session.
Control (Education): Usual care with only one educational session.
|
|---|---|---|
|
Maximal Inspiratory Pressure (MIP)
Within-Group Differences in Maximal Inspiratory Pressure Immediately After Rehabilitation
|
5.2 cm/H2O
Interval -2.2 to 12.6
|
8.3 cm/H2O
Interval 3.8 to 12.9
|
|
Maximal Inspiratory Pressure (MIP)
Within-Group Differences in Maximal Inspiratory Pressure at 4-Week Follow-Up
|
7.9 cm/H2O
Interval 0.4 to 15.4
|
5.4 cm/H2O
Interval -1.4 to 12.1
|
SECONDARY outcome
Timeframe: Immediately After Rehabilitation and at 4-Week Follow-UpSkeletal muscle index calculated by dividing appendicular skeletal muscle mass by height squared. Higher values indicate greater muscle mass. Unit of Measure: kg/m²
Outcome measures
| Measure |
Tele-rehabilitation Group
n=29 Participants
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)
|
Control Group
n=35 Participants
The control group receives usual care with only one educational session.
Control (Education): Usual care with only one educational session.
|
|---|---|---|
|
Skeletal Muscle Index (SMI)
Within-Group Differences in Skeletal Muscle Index Immediately After Rehabilitation
|
0.1 kg/m²
Interval -0.2 to 0.3
|
-0.1 kg/m²
Interval -0.6 to 0.3
|
|
Skeletal Muscle Index (SMI)
Within-Group Differences in Skeletal Muscle Index at 4-Week Follow-Up
|
0.1 kg/m²
Interval -0.01 to 0.2
|
0.11 kg/m²
Interval 0.01 to 0.2
|
SECONDARY outcome
Timeframe: Immediately After Rehabilitation and at 4-Week Follow-UpThe 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)
Outcome measures
| Measure |
Tele-rehabilitation Group
n=29 Participants
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)
|
Control Group
n=35 Participants
The control group receives usual care with only one educational session.
Control (Education): Usual care with only one educational session.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
Within-Group Differences in HADS Anxiety Score Immediately After Rehabilitation
|
-0.4 score on a scale
Interval -1.8 to 1.1
|
0.6 score on a scale
Interval -0.5 to 1.8
|
|
Hospital Anxiety and Depression Scale (HADS)
Within-Group Differences in HADS Anxiety Score at 4-Week Follow-Up
|
-0.9 score on a scale
Interval -2.2 to 0.4
|
-0.1 score on a scale
Interval -1.0 to 0.8
|
|
Hospital Anxiety and Depression Scale (HADS)
Within-Group Differences in HADS Depression Score Immediately After Rehabilitation
|
-1.1 score on a scale
Interval -2.4 to 0.2
|
-0.6 score on a scale
Interval -1.9 to 0.7
|
|
Hospital Anxiety and Depression Scale (HADS)
Within-Group Differences in HADS Depression Score at 4-Week Follow-Up
|
-1.0 score on a scale
Interval -2.5 to 0.5
|
-1.2 score on a scale
Interval -2.5 to 0.1
|
SECONDARY outcome
Timeframe: Immediately After Rehabilitation and at 4-Week Follow-UpThe 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
Outcome measures
| Measure |
Tele-rehabilitation Group
n=29 Participants
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)
|
Control Group
n=35 Participants
The control group receives usual care with only one educational session.
Control (Education): Usual care with only one educational session.
|
|---|---|---|
|
EQ-5D (EuroQol-5 Dimension)
Within-Group Differences in EQ-5D-5L Index Score Immediately After Rehabilitation
|
0.05 score on a scale
Interval 0.01 to 0.1
|
-0.03 score on a scale
Interval -0.07 to 0.01
|
|
EQ-5D (EuroQol-5 Dimension)
Within-Group Differences in EQ-5D-5L Index Score at 4-Week Follow-Up
|
0.05 score on a scale
Interval -0.01 to 0.1
|
0.0 score on a scale
Interval -0.05 to 0.04
|
|
EQ-5D (EuroQol-5 Dimension)
Within-Group Differences in EQ-5D-5L Visual Analog Scale Score Immediately After Rehabilitation
|
6.4 score on a scale
Interval 0.3 to 12.4
|
5.4 score on a scale
Interval -0.3 to 11.0
|
|
EQ-5D (EuroQol-5 Dimension)
Within-Group Differences in EQ-5D-5L Visual Analog Scale Score at 4-Week Follow-Up
|
7.9 score on a scale
Interval 0.7 to 15.1
|
7.7 score on a scale
Interval 2.3 to 13.1
|
SECONDARY outcome
Timeframe: Immediately After Rehabilitation and at 4-Week Follow-UpGrip 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.
Outcome measures
| Measure |
Tele-rehabilitation Group
n=29 Participants
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)
|
Control Group
n=35 Participants
The control group receives usual care with only one educational session.
Control (Education): Usual care with only one educational session.
|
|---|---|---|
|
Grip Strength
Within-Group Differences in Grip Strength Immediately After Rehabilitation
|
-0.3 Kg
Interval -1.6 to 0.9
|
0.1 Kg
Interval -0.9 to 1.2
|
|
Grip Strength
Within-Group Differences in Grip Strength at 4-Week Follow-Up
|
-0.7 Kg
Interval -2.3 to 0.8
|
-0.2 Kg
Interval -1.3 to 0.9
|
SECONDARY outcome
Timeframe: Immediately After Rehabilitation and at 4-Week Follow-UpAs 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.
Outcome measures
| Measure |
Tele-rehabilitation Group
n=29 Participants
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)
|
Control Group
n=35 Participants
The control group receives usual care with only one educational session.
Control (Education): Usual care with only one educational session.
|
|---|---|---|
|
Steps
Within-Group Differences in Daily Step Count Immediately After Rehabilitation
|
-45 steps/day
Interval -1090.4 to 1000.4
|
-469 steps/day
Interval -1605.5 to 666.7
|
|
Steps
Within-Group Differences in Daily Step Count at 4-Week Follow-Up
|
1050 steps/day
Interval -540.1 to 2640.6
|
95 steps/day
Interval -1147.7 to 1337.7
|
SECONDARY outcome
Timeframe: Immediately After Rehabilitation and at 4-Week Follow-UpThe 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).
Outcome measures
| Measure |
Tele-rehabilitation Group
n=29 Participants
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)
|
Control Group
n=35 Participants
The control group receives usual care with only one educational session.
Control (Education): Usual care with only one educational session.
|
|---|---|---|
|
Peak Expiratory Flow (PEF)
Within-Group Differences in Peak Expiratory Flow Immediately After Rehabilitation
|
14.2 L/min
Interval -14.8 to 43.2
|
27.4 L/min
Interval 3.8 to 51.0
|
|
Peak Expiratory Flow (PEF)
Within-Group Differences in Peak Expiratory Flow at 4-Week Follow-Up
|
28.7 L/min
Interval 12.4 to 45.0
|
24.1 L/min
Interval 6.0 to 42.2
|
SECONDARY outcome
Timeframe: Immediately After Rehabilitation and at 4-Week Follow-UpForced 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.
Outcome measures
| Measure |
Tele-rehabilitation Group
n=29 Participants
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)
|
Control Group
n=35 Participants
The control group receives usual care with only one educational session.
Control (Education): Usual care with only one educational session.
|
|---|---|---|
|
Forced Vital Capacity (FVC)
Within-Group Differences in Forced Vital Capacity Immediately After Rehabilitation
|
0.17 Liter
Interval 0.08 to 0.24
|
0.18 Liter
Interval 0.1 to 0.26
|
|
Forced Vital Capacity (FVC)
Within-Group Differences in Forced Vital Capacity at 4-Week Follow-Up
|
0.25 Liter
Interval 0.13 to 0.37
|
0.23 Liter
Interval 0.13 to 0.33
|
SECONDARY outcome
Timeframe: Immediately After Rehabilitation and at 4-Week Follow-UpThe 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.
Outcome measures
| Measure |
Tele-rehabilitation Group
n=29 Participants
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)
|
Control Group
n=35 Participants
The control group receives usual care with only one educational session.
Control (Education): Usual care with only one educational session.
|
|---|---|---|
|
The Forced Expiratory Volume in 1 Second (FEV1)
Within-Group Differences in Forced Expiratory Volume in 1 Second at 4-Week Follow-Up
|
0.19 Liter
Interval 0.09 to 0.28
|
0.15 Liter
Interval 0.07 to 0.23
|
|
The Forced Expiratory Volume in 1 Second (FEV1)
Within-Group Differences in Forced Expiratory Volume in 1 Second Immediately After Rehabilitation
|
0.14 Liter
Interval 0.07 to 0.21
|
0.11 Liter
Interval 0.06 to 0.16
|
SECONDARY outcome
Timeframe: Immediately After Rehabilitation and at 4-Week Follow-UpBioelectrical 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.
Outcome measures
| Measure |
Tele-rehabilitation Group
n=29 Participants
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)
|
Control Group
n=35 Participants
The control group receives usual care with only one educational session.
Control (Education): Usual care with only one educational session.
|
|---|---|---|
|
Whole-Body Phase Angle
Within-Group Differences in Whole-Body Phase Angle Immediately After Rehabilitation
|
0.04 degrees
Interval -0.09 to 0.16
|
-0.1 degrees
Interval -0.26 to 0.05
|
|
Whole-Body Phase Angle
Within-Group Differences in Whole-Body Phase Angle at 4-Week Follow-Up
|
-0.02 degrees
Interval -0.17 to 0.13
|
-0.12 degrees
Interval -0.29 to 0.05
|
Adverse Events
Tele-rehabilitation Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sanghun Kim
Department of Rehabilitation Medicine, Pusan National University Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place