Proteoglycan 4 Mechanism the Effectiveness of Pulmaonry Recovery in COPD Patients

NCT02764658 | Unknown DMC

• 1 other identifier: TMU-JIRB Ho1.2/20160212
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators previous research has demonstrated that proteoglycan 4 (PRG4) may be a biomarker for identification of severity in COPD. PRG4 was more sensitive and specific than CRP for confirming COPD severity and acute exacerbation frequency. It was related to the 1-year force vital capacity decline in COPD patients. The past study found that Prg4 is an immunomodulatory factor regulating parathyroid hormone actions on hematopoietic cells in mice. Previous report showed that voluntary wheel running and fluid flow shear stress that promote the expression of the Prg4 and association with pulmonary inflammation. COPD patients are characterized by a progressive decrease of lung function that is associated with increased in the airway and systemic inflammation. Pulmonary recovery (PR) is able to decrease acute exacerbation, maintain pulmonary function, increase exercise tolerance and improve quality of life in COPD patients, but it is unknown the mechanism of PRG4. The current study aimed to study in the pulmonary inflammation and the effectiveness of pulmonary recovery in COPD Patients：The mechanism of PRG 4.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• The systemic inflamation biomakers

  Measured the proteaglycan4、IL-6、IL-8、TNFα、CRP\& IL-10 from the supernatant with COPD patients

  0~12 months

Secondary Outcomes (2)

• Exercise capacity

  0~12 months

• The correlaton with the exercise capacity and systemic inflammationcytokines

  0~12 months

Study Arms (3)

Pulmonary recovery on the AECOPD

EXPERIMENTAL

Study in the pulmonary inflammation and the effectiveness of pulmonary recovery in AECOPD Patients

Device: Pulmonary recovery on the AECOPD; Other: Routine care on the AECOPD; Other: Routine care on the stable COPD

Routine care on the AECOPD

OTHER

Study in the pulmonary inflammation and the effectiveness of pulmonary recovery in AECOPD Patients

Other: Routine care on the AECOPD; Other: Routine care on the stable COPD

Routine care on the stable COPD

OTHER

Study in the pulmonary inflammation and the effectiveness of pulmonary recovery in stabel COPD Patients

Other: Routine care on the stable COPD

Interventions

Pulmonary recovery on the AECOPD DEVICE

The combination effect of negative pressure ventilation, limb muscle exercise training program and fibit monitor on acute exacerbation of AECOPD. To investigate the daily physical activity in routine care patients with after AECOPD and stable stage.

Also known as: Ergometer for limb muscle training, Negative pressure ventilator, Fibit monitor

Pulmonary recovery on the AECOPD

Routine care on the AECOPD OTHER

To investigate whether daily physical activity、hypoxia and hyperinflation were associated with airway inflammation and PRG4 in Routine care patients wtih AECOPD and stable stage.

Also known as: Physical daily activity, Fibit monitor

Pulmonary recovery on the AECOPD; Routine care on the AECOPD

Routine care on the stable COPD OTHER

To investigate whether daily physical activity、hypoxia and hyperinflation were associated with airway inflammation and PRG4 in Non-Pulmanary recovery patients wtih stable COPD.

Also known as: Physical daily activity, Fibit monitor

Pulmonary recovery on the AECOPD; Routine care on the AECOPD; Routine care on the stable COPD

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients with acute exacerbation of COPD
• GOLD diagnostic criteria based on the COPD, the use of inhaled bronchodilators: the first second forced expiratory volume (FEV1.0) / forced vital capacity (FVC) \<70%.
• Age ≧ 40 and ≦ 80 years old, is currently not accepting any research project.
• Physician assess the patient is currently in stable condition vital signs, complain dyspnea of exercise, consult RT for pulmonary rehabilitation.
• The purpose of this study by researchers explain, the researchers agreed to participate in this.
• Stable COPD outpatients
• GOLD diagnostic criteria based on the COPD, the use of inhaled bronchodilators: the first second forced expiratory volume (FEV1.0) / forced vital capacity (FVC) \<70%.
• Age ≧ 40 and ≦ 80 years old, is currently not accepting any research project.
• The purpose of this study by researchers explain, the researchers agreed to participate in this.

You may not qualify if:

• Hospitalized patients with acute exacerbation of COPD
• Unstable vital signs: blood pressure \<90 mm Hg, blood oxygen levels (SpO2) at Tx under still \<85%.
• Associated with neuromuscular function disorders such as hemiplegia or no independent walking function.
• Have been diagnosed with severe mental disorders, such as dementia or or unable to cooperating people.
• Stable COPD outpatients
• Over the past three months there have been acute infection or are in a state of acute attacks.
• Associated with neuromuscular function disorders such as hemiplegia or no independent walking function.
• Have been diagnosed with severe mental disorders, such as dementia or unable to cooperating people

Sponsors & Collaborators

• Taipei Medical University: lead

Related Publications (3)

• Ho SC, Lin HC, Kuo HP, Chen LF, Sheng TF, Jao WC, Wang CH, Lee KY. Exercise training with negative pressure ventilation improves exercise capacity in patients with severe restrictive lung disease: a prospective controlled study. Respir Res. 2013 Feb 19;14(1):22. doi: 10.1186/1465-9921-14-22.

  PMID: 23421438 BACKGROUND

• Lee KY, Chuang HC, Chen TT, Liu WT, Su CL, Feng PH, Chiang LL, Bien MY, Ho SC. Proteoglycan 4 is a diagnostic biomarker for COPD. Int J Chron Obstruct Pulmon Dis. 2015 Sep 18;10:1999-2007. doi: 10.2147/COPD.S90926. eCollection 2015.

  PMID: 26451097 BACKGROUND

• Wang CH, Chou PC, Joa WC, Chen LF, Sheng TF, Ho SC, Lin HC, Huang CD, Chung FT, Chung KF, Kuo HP. Mobile-phone-based home exercise training program decreases systemic inflammation in COPD: a pilot study. BMC Pulm Med. 2014 Aug 30;14:142. doi: 10.1186/1471-2466-14-142.

  PMID: 25175787 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ventilators, Negative-Pressure

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ventilators, Mechanical; Equipment and Supplies

Study Officials

• Shu-Chuan Ho

  School of Respiratory Therapy, College of Medicine, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: School of Respiratory Therapy

Study Record Dates

• First Submitted: May 1, 2016
• First Posted: May 6, 2016
• Study Start: May 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: May 9, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share