Postoperative Telerehabilitation in Older Adults

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05435885

Enrollment

Registered

2022-06-28

Start date

2022-07-25

Completion date

2024-02-16

Last updated

2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

OTHERPulmonary Tele-Rehabilitation

12 supervised training sessions via a specific mobile messenger during four weeks. (3 sessions/week)

OTHERControl (Education)

Usual care with only one educational session.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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), 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.

Secondary

Measure	Time frame	Description
Maximal Inspiratory Pressure (MIP)	Immediately After Rehabilitation and at 4-Week Follow-Up	Maximal inspiratory pressure measured using a handheld respiratory device. Higher values indicate stronger inspiratory muscles. Unit of Measure: cmH₂O
Skeletal Muscle Index (SMI)	Immediately After Rehabilitation and at 4-Week Follow-Up	Skeletal muscle index calculated by dividing appendicular skeletal muscle mass by height squared. Higher values indicate greater muscle mass. Unit of Measure: kg/m²
Hospital Anxiety and Depression Scale (HADS)	Immediately After Rehabilitation and at 4-Week Follow-Up	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)
Steps	Immediately After Rehabilitation and at 4-Week Follow-Up	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.
EQ-5D (EuroQol-5 Dimension)	Immediately After Rehabilitation and at 4-Week Follow-Up	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
Ventilatory Efficiency (VE/VCO₂ Slope)	Immediately After Rehabilitation and at 4-Week Follow-Up	VE/VCO₂ slope measured during CPET. Lower values indicate better ventilatory efficiency.
Peak Expiratory Flow (PEF)	Immediately After Rehabilitation and at 4-Week Follow-Up	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).
Forced Vital Capacity (FVC)	Immediately After Rehabilitation and at 4-Week Follow-Up	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.
The Forced Expiratory Volume in 1 Second (FEV1)	Immediately After Rehabilitation and at 4-Week Follow-Up	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.
Whole-Body Phase Angle	Immediately After Rehabilitation and at 4-Week Follow-Up	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.
Grip Strength	Immediately After Rehabilitation and at 4-Week Follow-Up	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.

Countries

South Korea

Participant flow

Recruitment details

A total of 96 participants were assessed for eligibility. Of these, 64 were randomized.

Participants by arm

Arm	Count
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)	29
Control Group The control group receives usual care with only one educational session. Control (Education): Usual care with only one educational session.	35
Total	64

Baseline characteristics

Characteristic	Tele-rehabilitation Group	Control Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	29 Participants	35 Participants	64 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	71.6 years STANDARD_DEVIATION 5	72.2 years STANDARD_DEVIATION 5	71.9 years STANDARD_DEVIATION 5
BMI	24 kg/m2 STANDARD_DEVIATION 3	24 kg/m2 STANDARD_DEVIATION 4	24 kg/m2 STANDARD_DEVIATION 3
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment South Korea	29 participants	35 participants	64 participants
Sex: Female, Male Female	14 Participants	14 Participants	28 Participants
Sex: Female, Male Male	15 Participants	21 Participants	36 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 29	0 / 35
other Total, other adverse events	0 / 29	0 / 35
serious Total, serious adverse events	0 / 29	0 / 35

Outcome results

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.

Time frame: Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)

Arm	Measure	Group	Value (MEAN)	Dispersion
Tele-rehabilitation Group	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
Tele-rehabilitation Group	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
Tele-rehabilitation Group	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
Tele-rehabilitation Group	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
Control Group	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)	19.82 mL/kg/min	Standard Deviation 3.89
Control Group	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)	23.09 mL/kg/min	Standard Deviation 4.73
Control Group	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)	19.85 mL/kg/min	Standard Deviation 4.02
Control Group	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)	20.41 mL/kg/min	Standard Deviation 3.62

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