search
Back to results

Effects of Comprehensive Postoperative Pulmonary Tele-Rehabilitation in Elderly Patients With Resectable Lung Cancer

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pulmonary Tele-Rehabilitation
Control (Education)
Sponsored by
Pusan National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telerehabilitation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • PusanNUHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Tele-rehabilitation group

Control group

Arm Description

The Tele-rehabilitation group performs 12 training sessions during four weeks. (3 sessions/week)

The control group receives usual care with only one educational session.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from Baseline in Anaerobic Threshold on the CardioPulmonary Exercise Test(CPET) after 4 weeks intervention.
The anaerobic threshold is the lowest intensity of exercise at which the production of lactate exceeds the body's ability to utilize lactate as fuel in aerobic metabolism.
Maximal Inspiratory Pressure (MIP)
Maximal inspiratory pressure (MIP, cmH2O) is a measure of the strength of inspiratory muscles, primarily the diaphragm.
Skeletal muscle index (SMI)
Skeletal muscle mass index (SMI, kg/m2) was calculated by dividing the limb skeletal muscle mass (kg) by the square of the height (m2) using bioimpedance analysis.
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)
EQ-5D (EuroQol-5 dimension)
EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D instrument comprises a short descriptive system questionnaire 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 5 levels: no problems(1) slight problems(2) moderate problems(3) severe problems(4) extreme problems(5) EQ VAS is numbered from 0 to 100. 100 means the best health the participant can imagine. 0 means the worst health the participant can imagine.
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.
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.
Exercise adherence rate
Exercise adherence is the extent to which a patient acts in accordance with the advised interval, exercise dose, and exercise dosing regimen.
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).
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.
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.
Phase angle (PA)
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.
The respiratory exchange ratio (RER)
The respiratory exchange ratio (RER) is the ratio between the metabolic production of carbon dioxide (CO2) and the uptake of oxygen (O2).

Full Information

First Posted
June 23, 2022
Last Updated
August 25, 2022
Sponsor
Pusan National University Hospital
Collaborators
National Research Foundation of Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT05435885
Brief Title
Effects of Comprehensive Postoperative Pulmonary Tele-Rehabilitation in Elderly Patients With Resectable Lung Cancer
Official Title
Effects of Comprehensive Postoperative Pulmonary Tele-Rehabilitation in Elderly Patients With Resectable Lung Cancer: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pusan National University Hospital
Collaborators
National Research Foundation of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telerehabilitation, Carcinoma, Non-Small-Cell Lung, Cardiopulmonary Exercise Test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele-rehabilitation group
Arm Type
Experimental
Arm Description
The Tele-rehabilitation group performs 12 training sessions during four weeks. (3 sessions/week)
Arm Title
Control group
Arm Type
Other
Arm Description
The control group receives usual care with only one educational session.
Intervention Type
Other
Intervention Name(s)
Pulmonary Tele-Rehabilitation
Intervention Description
12 supervised training sessions via a specific mobile messenger during four weeks. (3 sessions/week)
Intervention Type
Other
Intervention Name(s)
Control (Education)
Intervention Description
Usual care with only one educational session.
Primary Outcome Measure Information:
Title
Change from Baseline in VO2 peak (peak Oxygen uptake, mL/(kg·min)) on the CardioPulmonary Exercise Test(CPET) after 4 weeks intervention
Description
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)
Secondary Outcome Measure Information:
Title
Change from Baseline in Anaerobic Threshold on the CardioPulmonary Exercise Test(CPET) after 4 weeks intervention.
Description
The anaerobic threshold is the lowest intensity of exercise at which the production of lactate exceeds the body's ability to utilize lactate as fuel in aerobic metabolism.
Time Frame
Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Title
Maximal Inspiratory Pressure (MIP)
Description
Maximal inspiratory pressure (MIP, cmH2O) is a measure of the strength of inspiratory muscles, primarily the diaphragm.
Time Frame
Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Title
Skeletal muscle index (SMI)
Description
Skeletal muscle mass index (SMI, kg/m2) was calculated by dividing the limb skeletal muscle mass (kg) by the square of the height (m2) using bioimpedance analysis.
Time Frame
Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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)
Time Frame
Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Title
EQ-5D (EuroQol-5 dimension)
Description
EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D instrument comprises a short descriptive system questionnaire 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 5 levels: no problems(1) slight problems(2) moderate problems(3) severe problems(4) extreme problems(5) EQ VAS is numbered from 0 to 100. 100 means the best health the participant can imagine. 0 means the worst health the participant can imagine.
Time Frame
Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Title
Grip Strength
Description
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.
Time Frame
Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Title
Steps
Description
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.
Time Frame
Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Title
Exercise adherence rate
Description
Exercise adherence is the extent to which a patient acts in accordance with the advised interval, exercise dose, and exercise dosing regimen.
Time Frame
during 4weeks intervention
Title
Peak expiratory flow (PEF)
Description
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).
Time Frame
Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Title
Forced vital capacity (FVC)
Description
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.
Time Frame
Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Title
The forced expiratory volume in 1 second (FEV1)
Description
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.
Time Frame
Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Title
Phase angle (PA)
Description
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.
Time Frame
Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Title
The respiratory exchange ratio (RER)
Description
The respiratory exchange ratio (RER) is the ratio between the metabolic production of carbon dioxide (CO2) and the uptake of oxygen (O2).
Time Frame
Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Hun Kim, M.D.,Ph.D.
Phone
82-51-240-7485
Email
kel5504@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cho Hui Hong, bachelor
Phone
82-10-2595-8163
Email
hch8163@gmail.com
Facility Information:
Facility Name
PusanNUH
City
Pusan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Hun Kim

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Comprehensive Postoperative Pulmonary Tele-Rehabilitation in Elderly Patients With Resectable Lung Cancer

We'll reach out to this number within 24 hrs