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COPDNCT04122365

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

A study testing Chest Wall Mobilization Program in people with COPD, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
COPD
What is being tested?
Chest Wall Mobilization Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteHong Kong
Study dates
1 Oct 2019to Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site, 1 recruiting
  • Kowloon Hospital

    Kowloon, 000

    TSUI, 852-60329857, yytsui_amy@yahoo.com.hk

    TSUI

    Recruiting

Other trials in Hong Kong

About this study

Official title: Effectiveness of Chest Wall Mobilization Program in Improving Respiratory Function for Patients With Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial

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.

Read the detailed description
  1. Intervention for Study Group

Structured Chest Wall Mobilization Program

Chest Wall Mobilization Chest wall mobilization is one of the important techniques in chest physical therapy for increasing chest wall mobility and improving ventilation. Either passive or active chest mobilizations help to increase chest wall mobility, flexibility, and thoracic compliance. The mechanism of this technique increases the length of the intercostal muscles and therefore helps in performing effective muscle contraction. It improves the biomechanics of chest movement by enhancing direction of anterior-upward movement of lower costal and downward movement of diaphragm. Maximal relaxed recoiling of the chest wall helps in achieving effective contraction of intercostal muscle. Chest wall mobilization with breathing exercise was showed to effect clinical benefit in chronic lung disease especially COPD with lung hyperinflation or barrel-shaped chest. The technique of chest wall mobilization helps in chest wall flexibility, respiratory muscle function and ventilatory pumping, which helps to reduce dyspnoea and respiratory accessory muscle use.

The chest wall mobilization techniques include:

  1. Lateral flexion of chest wall
  2. Chest wall extension
  3. Lateral gliding of thoracic spine
  4. Pectoralis major muscle stretching

There is no standard of practice found on the current studied chest wall mobilization. As good practice for quality and safety assurance, the studied program was evaluated by two independent Physiotherapists expert with post-graduate qualification in Manual Therapy recognised by Physiotherapists Board of Hong Kong Government and the International Federation of Orthopaedic Manipulative Physical Therapists of World Confederation of Physical Therapy. Chest wall mobilization will be performed in a therapist-assisted manner by a single trained and certified American College of Sports Medicine (ACSM) Clinical Exercise Physiologist with more than 10 years' experience working in the speciality with chronic respiratory patients in respiratory medicine.

Subjects will be placed in the sitting position, lying on the back or sidelying position with knees bent to correct the lumbar curve, repositioning of the scapular waist as well as scapular and arm abduction in order to prevent postural compensations. Stretching was performed bilaterally as follows:

  1. Lateral flexion of chest wall Patient in supine and lateral position on a foam roller in the infra-axillary region, forearms flexed and hands resting on the occipital region; the therapist used both palmar region hand's to mobilize the ribs in the cranial and caudal direction.
  2. Chest wall extension Patient in supine lying on a foam roller in the mid-thoracic region, raise the arm over the head and grasp hold on a fixed wall bar about 10 inches from the surface of the plinth.
  3. Lateral gliding of thoracic spine It is a non-thrust transverse vertebral pressure as described by Maitland et al 2005. Patients in prone lying, arms to the side and head in a 'forehead rest position'. Mobilization was applied to the whole thoracic spine. The spinous process of T1 was identified by first locating C6 using the cervical extension method and then counting caudally. The therapist stood at the level of the vertebra to be mobilized on one side of the subject. The pad of the therapist's non-dominant thumb was placed in contact with the lateral aspect of the spinous process of T1, whereas the dominant thumb was placed on the dorsal side of the other thumb. Pressure was applied to the spinous process to produce small amplitude, low velocity oscillations into resistance to the end-range of the vertebra (Grades IV). This procedure was performed for 30 seconds, and then sequentially applied to the next caudal level. The same pattern of application was used on the patient's contralateral side.
  4. Pectoralis major stretching Patient in supine position, on the side to be stretched, the patient´s arm was abducted, forearm flexed and hand resting on the occipital region. The displacement was performed with one of the therapist's hands on the upper third of the arm and the other on the lateral region of the upper chest, following the direction of muscle fibres.

The therapist-assisted chest wall mobilization for stretching follow the guidelines of general stretching for skeletal muscles. Static stretching will be performed with the therapist assisted the movement to the available range and hold in that position with the muscle on tension to a point of a stretching sensation. The stretching will be carried out during the expiratory phase with two sets of ten consecutive incursions for each position and a one-minute rest between the series. The holding of the stretching sensation should last for 10 seconds. The intervention will be around 20 minutes in total.

For the participants in the Control group, they will be asked to stay in supine, sidelying and prone positions for around 20 minutes to standardize the treatment time and effect of positioning.

Intervention Group Home Exercise Program For maintenance of the intervention effect and further improvement of chest wall mobility as well as soft tissues elasticity. Self-stretching exercises of trunk extension, rotation, side flexion as well as stretching of the pectoralis major muscle will be taught to the patients as home exercise program. Participants will be asked to perform the home exercise program for 15 minutes, 3 days /week for 6 weeks. An individual exercise log-book with the diagram of the stretching exercises will be given to the subjects to follow the exercises and record down their participation. Weekly telephone contact to participant will be given for motivation and encouragement of program adherence and completing the log books.

II. Intervention for Control Group Subjects in the control group will be asked to maintain their physical activity level as usual. A 15-minute simple stretching exercise on large muscle group will be taught for standardization as a home exercise program. Five stretching exercises for arms and legs will be taught to the patient as a home exercise program. Participants will be asked to perform the home exercise program for 15 minutes, 3 days /week for 6 weeks. An individual exercise log-book with the diagram of the stretching exercises will be given to the subjects to follow the exercises and record down their participation. Same weekly telephone contact to participant will be given for motivation and encouragement of program adherence and completing the log books as that in intervention group.

III. Common Program for Both Groups Standardized Walking Exercise Exercise will be performed on a Gaitkeeper Mobility Research 2000T electronic treadmill (Cortland, New York) set at zero inclination during subject's follow-up visit at Physiotherapy Department of Kowloon Hospital. Each participant will perform 15 minutes supervised walking exercise at a speed maintain with the participant's target heart rate zone of 60-80% Heart Rate Maximum for cardiovascular training. Besides, the oxygen saturation during walking will be kept above 88%. An oximeter will be used to adjust walking speed and monitoring of HR and oxygen saturation.

Standardized Educational Session Three educational sessions (30 minutes for each session) will be included for both intervention group and control group at Physiotherapy Department of Kowloon Hospital. The content of the education include self-management of bronchial hygiene, breathing re-training, relaxation techniques and the importance of exercise. Education pamphlets will be given to both groups of patients.

Conditions
COPD
Being tested
Chest Wall Mobilization Program, Control
Keywords
Chest Wall Mobilization Program, Respiratory Function
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chest Wall Mobilization ProgramOther

    Soft tissue therapy and joints mobilization

  • ControlOther

    Routine limbs exercises and education

Study groups in NCT04122365
Study groupRoleWhat they receive
Interventional groupExperimentalChest Wall Mobilization Program
Receives: Other: Chest Wall Mobilization Program
Control GroupOtherRoutine limbs exercises and education
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lung Function

    FEV1, FVC and Ratio

    Measured: 4.5 months

  2. Respiratory Muscles Function

    Maximum Inspiratory Pressure, Maximum Expiratory Pressure

    Measured: 4.5 months

Secondary outcomes (8)
  1. Cervical and Thoracic Range of Movement

    Measurement of cervical and thoracic range of movement with motion sensor in degree

    Measured: 4.5 months

  2. Cervical and Respiratory Muscles Activity

    Electromyography measurement of cervical and respiratory muscles

    Measured: 4.5 months

  3. Respiratory Muscle Oxygenation

    Near Infrared Spectroscopy on intercostal muscles

    Measured: 4.5 months

  4. Thoracic Excursion

    Measurement of upper and lower thoracic expansion using tape measure in cm

    Measured: 4.5 months

  5. Six-Minute Walk Test

    Measurement of distance, SpO2, Heart rate

    Measured: 4.5 months

  6. Pressure Pain Threshold

    Use Pressure algometer for measure the pressure pain threshold

    Measured: 4.5 months

  7. Visual Analogue Scale

    A 10cm line to rate his or her pain.

    Measured: 4.5 months

  8. St George's Respiratory Questionnaire

    3 Domains: Symptoms, Activity and Impacts. A total score 0-100.

    Measured: 4.5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2019
  2. Study start1 Oct 2019
  3. Primary completionOct 2020 (estimated)
  4. Study completionJun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04122365
Sponsor's protocol ID
COPD Study
Status last verified
May 2019
First submitted
23 Jul 2019
Last updated
10 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

  • 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.

    PubMed 28286249
  • 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.

    PubMed 19406254
  • 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 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.

    PubMed 24053900
  • 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.

    PubMed 17870419
  • 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.

    PubMed 21838523
  • 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.

    PubMed 22703901
  • 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. doi: 10.4187/respcare.04742. Epub 2016 Oct 18.

    PubMed 27794081
  • 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.

    PubMed 19761957
  • 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.

    PubMed 18503806

Questions about this trial

What is this clinical trial studying?

A study testing Chest Wall Mobilization Program in people with COPD, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact TSUI (852-60329857, yytsui_amy@yahoo.com.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lung Function (time frame: 4.5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04122365, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.

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