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Effectiveness of Chest Wall Mobilization Program in Improving Respiratory Function for Patients With COPD

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ClinicalTrials.gov Identifier: NCT04122365
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
The Hong Kong Polytechnic University

Brief Summary:

Patients with severe COPD will be recruited from the Respiratory Outpatient Clinic of Kowloon Hospital.

Baseline (pre-intervention) assessment for all recruited subjects will be conducted by one physiotherapist assessor who is blinded to the group allocation of the subject for respiratory function, musculoskeletal performance, physical performance and quality of life. Then, the subjects will be randomly allocated into either the intervention group with therapist-assisted chest wall mobilization exercises, low intensity walking exercise, home exercises and education sessions or the control group with low intensity walking exercise, home exercises and education sessions. The intervention program will last for 6 weeks with 2 sessions / week (i.e. a total of 12 sessions) in accordance to the recommendation for exercise training programs for patients with COPD by the American College of Sports Medicine. Post-program evaluation will be conducted upon program completion at 6 week.

A follow-up session on 3 month after the completion of the program will be carried out to evaluate the cumulative effect of the chest wall mobilization program on respiratory function, musculoskeletal performance, exercise performance and quality of life of the patients.


Condition or disease Intervention/treatment Phase
COPD Other: Chest Wall Mobilization Program Other: Control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Chest Wall Mobilization Program in Improving Respiratory Function for Patients With Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Interventional group
Chest Wall Mobilization Program
Other: Chest Wall Mobilization Program
Soft tissue therapy and joints mobilization

Control Group
Routine limbs exercises and education
Other: Control
Routine limbs exercises and education




Primary Outcome Measures :
  1. Lung Function [ Time Frame: 4.5 months ]
    FEV1, FVC and Ratio

  2. Respiratory Muscles Function [ Time Frame: 4.5 months ]
    Maximum Inspiratory Pressure, Maximum Expiratory Pressure


Secondary Outcome Measures :
  1. Cervical and Thoracic Range of Movement [ Time Frame: 4.5 months ]
    Measurement of cervical and thoracic range of movement with motion sensor in degree

  2. Cervical and Respiratory Muscles Activity [ Time Frame: 4.5 months ]
    Electromyography measurement of cervical and respiratory muscles

  3. Respiratory Muscle Oxygenation [ Time Frame: 4.5 months ]
    Near Infrared Spectroscopy on intercostal muscles

  4. Thoracic Excursion [ Time Frame: 4.5 months ]
    Measurement of upper and lower thoracic expansion using tape measure in cm

  5. Six-Minute Walk Test [ Time Frame: 4.5 months ]
    Measurement of distance, SpO2, Heart rate

  6. Pressure Pain Threshold [ Time Frame: 4.5 months ]
    Use Pressure algometer for measure the pressure pain threshold

  7. Visual Analogue Scale [ Time Frame: 4.5 months ]
    A 10cm line to rate his or her pain.

  8. St George's Respiratory Questionnaire [ Time Frame: 4.5 months ]
    3 Domains: Symptoms, Activity and Impacts. A total score 0-100.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. COPD patients in out-patient setting: Patients with FEV1/FVC < 0.70 and

GOLD stage III ( Severe) :

30% < or = FEV1 < 50% predicted

*GOLD - Global Initiative for Chronic Obstructive Lung Disease

2. Ambulatory

3. Able to communicate

4. Competent to give written consent

Exclusion Criteria:

  1. Contraindications to chest wall mobilization:

    • Severe and unstable rib fracture
    • Metastasis bone cancer
    • Tuberculosis spondylitis
    • Severe osteoporosis
  2. Hospitalization due to acute exacerbation of COPD in recent 1 month
  3. Current Smoker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122365


Contacts
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Contact: TSUI 852-60329857 yytsui_amy@yahoo.com.hk

Locations
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Hong Kong
Kowloon Hospital Recruiting
Kowloon, Hong Kong, 000
Contact: TSUI    852-60329857    yytsui_amy@yahoo.com.hk   
Principal Investigator: TSUI         
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: TSUI Hong Kong Polytechnic University

Publications:
Balady, G.J., Berra, K.A., Golding, L.A., Gordan, N.F., Mahler, D,A., Myers, J.N., & Sheldahl, L.M. (2017). ACSM's Guidelines for Exercise Testing and Prescription. Philadelphia: Lippincott Williams & Wilkins.
Ekstrum, J.A., Lisa L. Black & Karen A. Paschal (2009). Effects of a Thoracic Mobility and Respiratory Exercise Program on Pulmonary Function and Functional Capacity in Older Adults. Physical & Occupational Therapy in Geriatrics, 27(4), 310-327.
Gosling, C., & Williams, K.A. (2004). Comparison of the effects of thoracic manipulation and rib raising on lung function of asymptomatic individuals. Journal of Osteopathic Medicine, 7, 103.
Heneghan, N., Adab, P., Jackman, S., & Balanos, G. (2015). Musculoskeletal dysfunction in chronic obstructive pulmonary disease (COPD): An observational study. International Journal of Therapy and Rehabilitation, 22(3), 119-128.
Kelzuyuki, Tabira, Sekikawa, Noriko, Iwashiro, Motoki, Kawato, Seiji, Sekikawa, Kiyokazu, Kawamata, Mikio, Oike, Takayuki. (2007). The immediate effect of chest mobilization tech. in patients of COPD. The Journal of Japanese Physical Therapy Association, 34(2), 59-64.
Parmar, D., & Bhise, A. (2015). The immediate effect of Chest mobilization technique on chest expansion in patients of COPD with restrictive impairment. International Journal of Science and Research, 4(6), 2413-2416.

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Responsible Party: The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT04122365     History of Changes
Other Study ID Numbers: COPD Study
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Hong Kong Polytechnic University:
Chest Wall Mobilization Program
Respiratory Function