Effects of CPRP on Patients Undergoing Lung Resection

NCT06432634 | Enrolling By Invitation

• 1 other identifier: 202400512B0
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to investigate the effectiveness of implementing a Comprehensive Pulmonary Rehabilitation Program (CPRP) in patients undergoing lung resection surgery. The CPRP encompasses a training regimen combining aerobic exercise, resistance exercises, breathing exercises, and home activities, specifically tailored for patients with limited exercise capacity and impaired lung function. The study seeks to understand the physiological and biological effects of the CPRP in this patient population.

Conditions

Rehabilitation

Keywords

lung resection surgery; comprehensive pulmonary rehabilitation programs; six-minute walk test; quality of life; biomarkers

Outcome Measures

Primary Outcomes (1)

• Six-minute walk distance (6MWD)

  Six-minute walk test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance.

  Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks

Secondary Outcomes (8)

• Pulmonary function test

  Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks

• Respiratory muscle strength

  Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks

• Length of hospital stay (LoS)

  an average of post-surgery 2 weeks

• Duration of chest-tube insertion

  an average of post-surgery 2 weeks

• Numerical Rating Scale (NRS)

  Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks

Other Outcomes (1)

• inflammation-related and immune-related biomarkers

  Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks

Study Arms (2)

standard care group

SHAM COMPARATOR

Participants randomize to the standard care group (SC) receive the standard care already established in Chiayi Chang Gung Memorial Hospital. Standard care comprises one therapeutic education session conducted by a respiratory therapist 1-2 weeks before surgery.

Other: Standard care

comprehensive pulmonary rehabilitation program group

EXPERIMENTAL

Participants randomize to the comprehensive pulmonary rehabilitation program group (CPRP) undergo an evidence-based and hospital-based comprehensive pulmonary rehabilitation program developed by the research group. This program is administered in addition to the standard care provided and spans across the preoperative, peri-operative, and postoperative periods, covering a total of 1-2 weeks preoperatively and 3-6 weeks postoperatively. CPRP involves warm-up and cool-down exercises, the aerobic training, and the resistance training. Additionally, participants are encouraged to continue exercising at home or in community sports facilities.

Other: Standard care; Other: Comprehensive pulmonary rehabilitation programs

Interventions

Standard care OTHER

The pre-operative educational session has a duration of 40 minutes and covers pre-operative education, breathing exercises (diaphragmatic breathing, deep breathing techniques and sustained maximal inflation), and airway clearance techniques (directed cough, huffing, and chest physiotherapy). Patients are instructed to perform these techniques ten times per waking hour, every day. The in-patient peri-operative session incorporates intermittent positive pressure breathing inhalation (IPPB) administered for 15 minutes twice daily. Inhalation therapy involving mucolytics and bronchodilators is administered three times per day, and early mobilization is encouraged until discharge. Upon discharge, participants are encouraged to continue practicing breathing exercises, deep breathing techniques, and maintaining an active level of activity.

comprehensive pulmonary rehabilitation program group; standard care group

Comprehensive pulmonary rehabilitation programs OTHER

1. Warm-up and cool-down exercises: stretching various muscle groups for a duration of 15 to 20 minutes and a slow 3-minute walk 2. Aerobic training: using a lower-limb cycle ergometer for a duration of 30 to 40 minutes. Initiated warm-up at 0 wattages for 5 minutes. Incrementally increased wattages within 5-10 minutes until reaching the 40-80% heart rate reserve or 4 to 6 of modified Borg scale for at least 20 minutes. Concludes with a 5-minute cool-down period at 10 wattages. 3. The resistance training involves both upper and lower limbs: （1） Upper Limb Resistance Training: Shoulder lift, abduction, and horizontal abduction exercises are performed. Each exercise is repeated for three sessions comprising 10 repetitions each. A 0.5-2 kg dumbbell is utilized for resistance. （2） Lower Limb Resistance Training: Sit-to-stand exercises are performed. Each session consists of three sets of 10 repetitions.

comprehensive pulmonary rehabilitation program group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age ≥ 20 years old)
• Receiving lung resection surgery
• At least one of the following:
• MWD \< 500 meters, oxygen saturation by pulse oximetry (SpO2) drop ≥ 4% or SpO2\< 90% during 6MWT, pre-operative forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) ≤ 80% of predicted value or FEV1/FVC ratio ≤ 0.7
• Able to walk autonomously without mobility aids
• Written informed consent

You may not qualify if:

• Neoadjuvant therapy with chemo- or radiotherapy in the six months prior to surgery
• Received pulmonary rehabilitation programs six months prior to surgery
• Previous lung resection
• Inability to perform the exercise training
• Instability in cardiovascular disease, neurological disorders, or musculoskeletal conditions
• Have cognitive deficits with potential severe impact on compliance
• Do not provide written informed consent

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Chiayi City, Taiwan

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Chun-Jung Chang

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The blinding of patients to their treatment group allocation is unattainable owing to the inherent nature of the exercise intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 29, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)