NCT04122365

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

October 10, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

July 23, 2019

Last Update Submit

October 8, 2019

Conditions

Keywords

Chest Wall Mobilization ProgramRespiratory Function

Outcome Measures

Primary Outcomes (2)

  • Lung Function

    FEV1, FVC and Ratio

    4.5 months

  • Respiratory Muscles Function

    Maximum Inspiratory Pressure, Maximum Expiratory Pressure

    4.5 months

Secondary Outcomes (8)

  • Cervical and Thoracic Range of Movement

    4.5 months

  • Cervical and Respiratory Muscles Activity

    4.5 months

  • Respiratory Muscle Oxygenation

    4.5 months

  • Thoracic Excursion

    4.5 months

  • Six-Minute Walk Test

    4.5 months

  • +3 more secondary outcomes

Study Arms (2)

Interventional group

EXPERIMENTAL

Chest Wall Mobilization Program

Other: Chest Wall Mobilization Program

Control Group

OTHER

Routine limbs exercises and education

Other: Control

Interventions

Soft tissue therapy and joints mobilization

Interventional group
ControlOTHER

Routine limbs exercises and education

Control Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. COPD patients in out-patient setting: Patients with FEV1/FVC \< 0.70 and
  • GOLD stage III ( Severe) :
  • % \< or = FEV1 \< 50% predicted
  • \*GOLD - Global Initiative for Chronic Obstructive Lung Disease
  • \. Ambulatory
  • \. Able to communicate
  • \. Competent to give written consent

You may not qualify if:

  • Contraindications to chest wall mobilization:
  • Severe and unstable rib fracture
  • Metastasis bone cancer
  • Tuberculosis spondylitis
  • Severe osteoporosis
  • Hospitalization due to acute exacerbation of COPD in recent 1 month
  • Current Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kowloon Hospital

Kowloon, 000, Hong Kong

RECRUITING

Related Publications (15)

  • 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.

    BACKGROUND
  • de Sa RB, Pessoa MF, Cavalcanti AGL, Campos SL, Amorim C, Dornelas de Andrade A. Immediate effects of respiratory muscle stretching on chest wall kinematics and electromyography in COPD patients. Respir Physiol Neurobiol. 2017 Aug;242:1-7. doi: 10.1016/j.resp.2017.03.002. Epub 2017 Mar 10.

    PMID: 28286249BACKGROUND
  • Duiverman ML, de Boer EW, van Eykern LA, de Greef MH, Jansen DF, Wempe JB, Kerstjens HA, Wijkstra PJ. Respiratory muscle activity and dyspnea during exercise in chronic obstructive pulmonary disease. Respir Physiol Neurobiol. 2009 Jun 30;167(2):195-200. doi: 10.1016/j.resp.2009.04.018. Epub 2009 May 3.

    PMID: 19406254BACKGROUND
  • 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.

    BACKGROUND
  • Engel RM, Vemulpad SR, Beath K. Short-term effects of a course of manual therapy and exercise in people with moderate chronic obstructive pulmonary disease: a preliminary clinical trial. J Manipulative Physiol Ther. 2013 Oct;36(8):490-6. doi: 10.1016/j.jmpt.2013.05.028. Epub 2013 Sep 17.

    PMID: 24053900BACKGROUND
  • Engel RM, Vemulpad S. The effect of combining manual therapy with exercise on the respiratory function of normal individuals: a randomized control trial. J Manipulative Physiol Ther. 2007 Sep;30(7):509-13. doi: 10.1016/j.jmpt.2007.07.006.

    PMID: 17870419BACKGROUND
  • Engel R, Vemulpad S. The role of spinal manipulation, soft-tissue therapy, and exercise in chronic obstructive pulmonary disease: a review of the literature and proposal of an anatomical explanation. J Altern Complement Med. 2011 Sep;17(9):797-801. doi: 10.1089/acm.2010.0517. Epub 2011 Aug 12.

    PMID: 21838523BACKGROUND
  • 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.

    BACKGROUND
  • Heneghan NR, Adab P, Balanos GM, Jordan RE. Manual therapy for chronic obstructive airways disease: a systematic review of current evidence. Man Ther. 2012 Dec;17(6):507-18. doi: 10.1016/j.math.2012.05.004. Epub 2012 Jun 15.

    PMID: 22703901BACKGROUND
  • 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.

    BACKGROUND
  • Kaneko H, Shiranita S, Horie J, Hayashi S. Reduced Chest and Abdominal Wall Mobility and Their Relationship to Lung Function, Respiratory Muscle Strength, and Exercise Tolerance in Subjects With COPD. Respir Care. 2016 Nov;61(11):1472-1480. doi: 10.4187/respcare.04742. Epub 2016 Oct 18.

    PMID: 27794081BACKGROUND
  • 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.

    BACKGROUND
  • Leelarungrayub D, Pothongsunun P, Yankai A, Pratanaphon S. Acute clinical benefits of chest wall-stretching exercise on expired tidal volume, dyspnea and chest expansion in a patient with chronic obstructive pulmonary disease: a single case study. J Bodyw Mov Ther. 2009 Oct;13(4):338-43. doi: 10.1016/j.jbmt.2008.11.004. Epub 2009 Jan 29.

    PMID: 19761957BACKGROUND
  • 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.

    BACKGROUND
  • Putt MT, Watson M, Seale H, Paratz JD. Muscle stretching technique increases vital capacity and range of motion in patients with chronic obstructive pulmonary disease. Arch Phys Med Rehabil. 2008 Jun;89(6):1103-7. doi: 10.1016/j.apmr.2007.11.033.

    PMID: 18503806BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Study Officials

  • TSUI

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2019

First Posted

October 10, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2020

Study Completion

June 1, 2021

Last Updated

October 10, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations