COPD Clinical Trial
Official title:
Effectiveness of Chest Wall Mobilization Program in Improving Respiratory Function for Patients With Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial
NCT number | NCT04122365 |
Other study ID # | COPD Study |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2019 |
Est. completion date | June 2021 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 2021 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Kowloon Hospital | Kowloon |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University |
Hong Kong,
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.
de Sá 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. — View Citation
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. — View Citation
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.
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. Review. — View Citation
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. — View Citation
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. — View Citation
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 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. Review. — View Citation
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.
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. Epub 2016 Oct 18. — View Citation
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.
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. — View Citation
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.
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. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lung Function | FEV1, FVC and Ratio | 4.5 months | |
Primary | Respiratory Muscles Function | Maximum Inspiratory Pressure, Maximum Expiratory Pressure | 4.5 months | |
Secondary | Cervical and Thoracic Range of Movement | Measurement of cervical and thoracic range of movement with motion sensor in degree | 4.5 months | |
Secondary | Cervical and Respiratory Muscles Activity | Electromyography measurement of cervical and respiratory muscles | 4.5 months | |
Secondary | Respiratory Muscle Oxygenation | Near Infrared Spectroscopy on intercostal muscles | 4.5 months | |
Secondary | Thoracic Excursion | Measurement of upper and lower thoracic expansion using tape measure in cm | 4.5 months | |
Secondary | Six-Minute Walk Test | Measurement of distance, SpO2, Heart rate | 4.5 months | |
Secondary | Pressure Pain Threshold | Use Pressure algometer for measure the pressure pain threshold | 4.5 months | |
Secondary | Visual Analogue Scale | A 10cm line to rate his or her pain. | 4.5 months | |
Secondary | St George's Respiratory Questionnaire | 3 Domains: Symptoms, Activity and Impacts. A total score 0-100. | 4.5 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06000696 -
Healthy at Home Pilot
|
||
Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Completed |
NCT04105075 -
COPD in Obese Patients
|
||
Recruiting |
NCT05825261 -
Exploring Novel Biomarkers for Emphysema Detection
|
||
Active, not recruiting |
NCT04075331 -
Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial
|
Phase 2/Phase 3 | |
Terminated |
NCT03640260 -
Respiratory Regulation With Biofeedback in COPD
|
N/A | |
Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|
||
Withdrawn |
NCT04210050 -
Sleep Ventilation for Patients With Advanced Hypercapnic COPD
|
N/A | |
Terminated |
NCT03284203 -
Feasibility of At-Home Handheld Spirometry
|
N/A | |
Recruiting |
NCT06110403 -
Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT06040424 -
Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
|
Phase 3 | |
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Recruiting |
NCT04868357 -
Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program
|
N/A | |
Completed |
NCT01892566 -
Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV
|
N/A | |
Completed |
NCT04119856 -
Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD
|
N/A | |
Completed |
NCT04485741 -
Strados System at Center of Excellence
|
||
Completed |
NCT03626519 -
Effects of Menthol on Dyspnoea in COPD Patients
|
N/A | |
Recruiting |
NCT04860375 -
Multidisciplinary Management of Severe COPD
|
N/A |