Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04348344
Other study ID # 2019-161-K110
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date September 1, 2021

Study information

Verified date May 2020
Source China-Japan Friendship Hospital
Contact Ting Yang, MD
Phone 13651380809
Email dryangting@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, patients with Chronic Obstructive Pulmonary Diseases (COPD) in stable and acute exacerbation stage were selected as the research objects, and the open, parallel and randomized controlled clinical trial design was adopted. Participants were randomly divided into trial group and control group. The control group was only given routine education, and the experimental group, on the basis of routine education, developed a respiratory rehabilitation training program lasting for 12 weeks according to the individual situation of patients. All participants were interviewed for 6 times (baseline and 4,8,12 weeks, 6 months and 12 months after admission) for a period of 1 year. Acute exacerbation, activity tolerance (6-minute walking test), living environment, clinical symptoms, lung function, airway inflammation water level index and biological samples were collected at each visit. At the same time, according to the diary filled in by the patients, the investigators can obtain the daily stay time indoors and outdoors and the longitude and latitude information of the regular stay fixed place, and geographic information system (GIS) is used to match the nearest environmental monitoring station, obtain the data of air pollutants and meteorological indicators (SO2, NO2, Co, O3, PM10, temperature and humidity, etc.), and estimate the individual exposure level of air pollutants.


Description:

First of all, the investigators need to obtain detailed history records, including cardio pulmonary vascular history, related complications, treatment history and other high-risk factors. After careful review, the investigators need to determine whether the patient is suitable to participate in the pulmonary rehabilitation plan. The investigators need to pay special attention to diseases that may affect the patient's performance, including special cardiovascular diseases, skeletal muscle and nervous system.

Functional evaluation: pulmonary function test, exercise cardiopulmonary function evaluation (6-minute walking test), grip strength test, psychological state evaluation ( Generalized Anxiety Disorder 7-item (GAD-7), Patient Health Questionnaire 9-item (phq-9)), nutrition screening and evaluation and others (general examination such as height, weight, BMI, waist and hip circumference, WHR, blood pressure, heart rate and blood biochemical examination; quality of life evaluation; other related individual evaluation Estimation includes smoking and sleep).

1. Acute exacerbation:

The exercise prescription of "hospitalization + home rehabilitation" was adopted, which mainly combined aerobic endurance training, intermittent strength training and inspiratory muscle training, as follows:

Aerobic exercise: 4 times / week, 30min / time, fast walking or power cycling Strength training: unarmed or instrument, 4 times / week, 3 groups / time, 10-12 times / group Breath training: ① breath Trainer: once a day, 20-30min a time

② Abdominal breathing training: 1-2 times / day, 10min / time

2. Stable patients:

Using the "home-based rehabilitation" exercise prescription, taking home exercise as the main form, using the sports bracelet and special respiratory rehabilitation app software, the home management system integrating home rehabilitation training, detection and feedback is mainly adopted, which is a combination of aerobic endurance training, intermittent strength training and inspiratory muscle training, as follows:

Aerobic exercise: 2-3 times / week, 30min / time, walk quickly Strength training: elastic band, 2-3 times / week, 3 groups / time, 10-12 times / group Breathing training: ① breathing exercise apparatus, 1-2 times / day, 10min / time

② Abdominal breathing training, 1-2 times / day, 10min / time


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 522
Est. completion date September 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- It meets the diagnostic criteria of global initiative for chronic obstructive pulmonary disease (gold 2017 Edition), is in a stable period of disease or meets the diagnostic criteria of guidelines for the prevention and treatment of bronchial asthma (GINA 2016 Edition)

- Have lived in the local area for more than 2 consecutive years, and there is no plan to go out for more than half a year in succession during the survey period

- No smoking history or no smoking for half a year or more

- 40-75 years old

Exclusion Criteria:

- Patients with history of chronic diseases, such as serious cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, epilepsy and other nervous system diseases, mental diseases, psychiatric diseases, active pulmonary tuberculosis, tumor, anti tuberculosis treatment or combined influence information collection

- Patients who have undergone thoracic, abdominal and ophthalmic operations in the past 3 months

- Pregnant and lactating women

- Did not sign informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
pulmonary rehabilitation
Patients receive health education of pulmonary rehabilitation, using the "home-based rehabilitation" exercise prescription, taking home exercise as the main form, using the sports bracelet and special respiratory rehabilitation app software, the home management system integrating home rehabilitation training, detection and feedback is mainly adopted, which is a combination of aerobic endurance training: walking, intermittent strength training: elastic band and inspiratory muscle training:apparatus, abdominal breathing training.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
China-Japan Friendship Hospital

References & Publications (5)

Alison JA, McKeough ZJ, Johnston K, McNamara RJ, Spencer LM, Jenkins SC, Hill CJ, McDonald VM, Frith P, Cafarella P, Brooke M, Cameron-Tucker HL, Candy S, Cecins N, Chan AS, Dale MT, Dowman LM, Granger C, Halloran S, Jung P, Lee AL, Leung R, Matulick T, O — View Citation

Loeckx M, Rabinovich RA, Demeyer H, Louvaris Z, Tanner R, Rubio N, Frei A, De Jong C, Gimeno-Santos E, Rodrigues FM, Buttery SC, Hopkinson NS, Büsching G, Strassmann A, Serra I, Vogiatzis I, Garcia-Aymerich J, Polkey MI, Troosters T. Smartphone-Based Phys — View Citation

Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van — View Citation

Storer TW. Exercise in chronic pulmonary disease: resistance exercise prescription. Med Sci Sports Exerc. 2001 Jul;33(7 Suppl):S680-92. Review. — View Citation

Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change from Baseline Body Mass Index (BMI) at 4, 8, 12 weeks, 6 months and 12 months weight and height will be combined to report BMI in kg/m^2 baseline and 4, 8, 12 weeks, 6 months and 12 months
Other Change from Baseline Weight in Kilograms at 4, 8, 12 weeks, 6 months and 12 months weight in kilograms baseline and 4, 8, 12 weeks, 6 months and 12 months
Other Change from Baseline Height in Meters at 4, 8, 12 weeks, 6 months and 12 months height in meters baseline and 4, 8, 12 weeks, 6 months and 12 months
Other Change from Waist Circumference in Centimeters at 4, 8, 12 weeks, 6 months and 12 months waist circumference in centimeters baseline and 4, 8, 12 weeks, 6 months and 12 months
Other Change from Hip Circumference in Centimeters at 4, 8, 12 weeks, 6 months and 12 months hip circumference in centimeters baseline and 4, 8, 12 weeks, 6 months and 12 months
Other Change from Waist-Hip Ratio (WHR) at 4, 8, 12 weeks, 6 months and 12 months hip and waist circumference in centimeters will be combined to report WHR baseline and 4, 8, 12 weeks, 6 months and 12 months
Primary Change from Baseline 6-minute Walking Distance at 4, 8, 12 weeks, 6 months and 12 months walking distance in 6-minute walking test baseline and 4, 8, 12 weeks, 6 months and 12 months
Primary Times of acute exacerbation times of acute exacerbation in the period of one year through study completion, an average of 1 year
Secondary Time from the beginning of follow-up to the first acute exacerbation and the duration of the first acute exacerbation Time from the beginning of follow-up to the first acute exacerbation and the duration of the first acute exacerbation 9 months
Secondary Change from Baseline Fractional exhaled Nitric Oxide (FeNO) at 4, 8, 12 weeks, 6 months and 12 months changes of Fractional exhaled Nitric Oxide (FeNO) baseline and 4, 8, 12 weeks, 6 months and 12 months
Secondary Change from Baseline Eosinophil Count in Sputum at 4, 8, 12 weeks, 6 months and 12 months Eosinophil Count baseline and 4, 8, 12 weeks, 6 months and 12 months
Secondary Change from Baseline Inflammatory Factors in sputum at 4, 8, 12 weeks, 6 months and 12 months inflammatory factors in sputum baseline and 4, 8, 12 weeks, 6 months and 12 months
Secondary Change from Baseline modified Medical Research Council dyspnea (mMRC) at 4, 8, 12 weeks, 6 months and 12 months the minimum values is 0 and maximum values is 4, the higher scores mean a worse outcome. baseline and 4, 8, 12 weeks, 6 months and 12 months
Secondary Change from Baseline COPD assessment test (CAT) at 4, 8, 12 weeks, 6 months and 12 months the minimum values is 0 and maximum values is 40, the higher scores mean a worse outcome. baseline and 4, 8, 12 weeks, 6 months and 12 months
Secondary Change from Baseline St George's questionnaire (SGRQ) at 4, 8, 12 weeks, 6 months and 12 months the minimum values is 0 and maximum values is 100, the higher scores mean a worse outcome. baseline and 4, 8, 12 weeks, 6 months and 12 months
Secondary Change from Baseline Patient Health Questionnaire 9-item (PHQ-9) at 4, 8, 12 weeks, 6 months and 12 months the minimum values is 0 and maximum values is 27, the higher scores mean a worse outcome. baseline and 4, 8, 12 weeks, 6 months and 12 months
Secondary Change from Baseline Generalized Anxiety Disorder 7-item (GAD-7) at 4, 8, 12 weeks, 6 months and 12 months the minimum values is 0 and maximum values is 21, the higher scores mean a worse outcome. baseline and 4, 8, 12 weeks, 6 months and 12 months
Secondary Change from Baseline Pittsburgh Sleep Quality Index (PSQI) at 4, 8, 12 weeks, 6 months and 12 months the minimum values is 0 and maximum values is 21, the higher scores mean a worse outcome. baseline and 4, 8, 12 weeks, 6 months and 12 months
Secondary Change from Baseline Pulmonary Function of FEV1 at 4, 8, 12 weeks, 6 months and 12 months FEV1 baseline and 4, 8, 12 weeks, 6 months and 12 months
Secondary Change from Baseline Pulmonary Function of FVC at 4, 8, 12 weeks, 6 months and 12 months FVC baseline and 4, 8, 12 weeks, 6 months and 12 months
Secondary Change from Baseline Pulmonary Function of FEV1/FVC at 4, 8, 12 weeks, 6 months and 12 months FEV1/FVC baseline and 4, 8, 12 weeks, 6 months and 12 months
See also
  Status Clinical Trial Phase
Completed NCT05102305 - A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
Completed NCT01867762 - An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Phase 2
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03089515 - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust N/A
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT05552833 - Pulmonary Adaptive Responses to HIIT in COPD N/A
Recruiting NCT05835492 - A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Completed NCT03244137 - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting NCT03282526 - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease N/A
Completed NCT02546700 - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Withdrawn NCT04446637 - Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD Phase 3
Completed NCT04535986 - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Completed NCT03256695 - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Withdrawn NCT04042168 - Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT03414541 - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02552160 - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy