Clinical trial NCT05435885: Postoperative Telerehabilitation in Older Adults
Official title: Comparison of Postoperative Telerehabilitation and Unsupervised Home-Based Training in Older Adults With Lung Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telerehabilitation
Carcinoma, Non-Small-Cell Lung
Cardiopulmonary Exercise Test
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2022-06-28
Enrollment: 64
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in VO2 Peak (Peak Oxygen Uptake, mL/kg/Min) on the CardioPulmonary Exercise Test(CPET) After 4 Weeks Intervention
timeFrame: Before surgery (Pre), Baseline (4 weeks after surgery), After intervention(8 weeks after surgery), Follow up(12 weeks after surgery)
Secondary outcomes:
measure: Ventilatory Efficiency (VE/VCO₂ Slope)
timeFrame: Immediately After Rehabilitation and at 4-Week Follow-Up
measure: Maximal Inspiratory Pressure (MIP)
timeFrame: Immediately After Rehabilitation and at 4-Week Follow-Up
measure: Skeletal Muscle Index (SMI)
timeFrame: Immediately After Rehabilitation and at 4-Week Follow-Up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Immediately After Rehabilitation and at 4-Week Follow-Up
measure: EQ-5D (EuroQol-5 Dimension)
timeFrame: Immediately After Rehabilitation and at 4-Week Follow-Up
measure: Grip Strength
timeFrame: Immediately After Rehabilitation and at 4-Week Follow-Up
measure: Steps
timeFrame: Immediately After Rehabilitation and at 4-Week Follow-Up
measure: Peak Expiratory Flow (PEF)
timeFrame: Immediately After Rehabilitation and at 4-Week Follow-Up
measure: Forced Vital Capacity (FVC)
timeFrame: Immediately After Rehabilitation and at 4-Week Follow-Up
measure: The Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Immediately After Rehabilitation and at 4-Week Follow-Up
measure: Whole-Body Phase Angle
timeFrame: Immediately After Rehabilitation and at 4-Week Follow-Up
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: PusanNUH
Study officials:
affiliation: Pusan National University Hospital
name: Sang Hun Kim, M.D.,Ph.D.
role: STUDY_DIRECTOR
References: