NCT06865703

Brief Summary

This study will test the efficiency of rib rising technique and thoracic lymphatic pump technique combining with manual diaphragmatic release technique in patients with chronic obstructive pulmonary disease

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 24, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

March 20, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

February 24, 2025

Last Update Submit

April 26, 2026

Conditions

Keywords

diaphragmatic releaserib raisingthoracic lymphatic pump

Outcome Measures

Primary Outcomes (2)

  • Diaphragmatic Excursion

    ultrasonography device applied on chest and used to measure the vertical movement of diaphragm unite of measure is centimeter (cm)

    all assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months

  • Diaphragmatic thickness

    ultrasonography device applied on chest and used to measure diaphragmatic thickness and change of flexibility of the diaphragm unite of measure is millimeter (mm)

    all assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months

Secondary Outcomes (6)

  • Level of Dyspnea

    all assessment will be performed two times one pretreatment and then will be repeated post treatment almost 2 months

  • Oxygen saturation (%)

    assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months

  • Resting Heart rate

    assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months

  • Pulmonary function test (spirometry)

    all assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months

  • maximum heart rate

    assessment will be performed two times one pretreatment and will be repeated post treatment almost 2 months

  • +1 more secondary outcomes

Study Arms (3)

group A

OTHER

Combination between rib raising and diaphragmatic release technique

Other: diaphragmatic release techniqueOther: rib raising technique in group A

group B

OTHER

combination between thoracic lymphatic pump and diaphragmatic release technique

Other: diaphragmatic release techniqueOther: THORACIC LYMPHATIC PUMP TECHNIGUE

group C (control group)

OTHER

Diaphragmatic release technique (control group)

Other: diaphragmatic release technique

Interventions

The participant lay in the supine position and the therapist stood at the participant's head, the therapist passed his hands (the hypothenar and the lateral 3 fingers) under the costal cartilage of the seventh to the tenth ribs bilaterally, with the therapist's forearm aligned up toward the subject's shoulder. Then, the therapist quietly drew the diaphragm in and upward during the inspiratory phase. The therapist then went deeply with both hands toward the inner costal margin during the expiratory phase to resist the rebounding movement of the thoracic cage. The depth of this manual contact was progressively increased in subsequent respiratory cycles. The maneuver was repeated in 4 sets, each of which consisted of 5 deep breaths with 2-min intervals in between if needed

group Agroup Bgroup C (control group)

• The patient is in supine position and therapist hand under the thorax The fingertips take up contact with the angular costae and move it up and in lateral traction and maintained and this will repeated until all ribs on the side are mobilized. This movement will be repeated several times until perceives an improvement in the rib flexibility

group A

* Patient in the supine position and therapist will stand the participant's head, facing The therapist places the thenar eminence of each hand to the pectoral region and infra clavicular and the other fingers were spread around the thoracic cage and angled toward the body's side to create consistent, compressive force across the thoracic cage The participant was then allowed to breathe in deeply and breath out. The therapist slowly reduced the compressive force and withdrew the participant. * During breath out rhythmic oscillatory compression in the posterior and caudal direction was applied to the chest wall. * By the end of the expiratory phase, the compressive force was maintained, and ask to take another deep breath. In this way, the participant encountered some resistance equivalent to the chest-wall movement during inspiration. The maneuver was repeated for 5 respiratory cycles, then hands to allow for full inspiration.

group B

Eligibility Criteria

Age60 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale gender with age 60 to75 years old stable copd
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* include Stable COPD patients * include Constant medication between the treatments. * include Aged from 60 TO 75 YEARS OLD * include moderate to severe COPD * include Smoker index \<400 * exclude Rib or vertebral fracture * exclude Skin disorder or scar in chest region or recent abdominal surgery. * exclude Unwilling to complete in study * exclude Cancer * exclude Cognitive impairment to understand orders * exclude severe osteoporosis * exclude Smoker index \>400

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Beni Suef University

Cairo, Egypt

Location

Related Publications (12)

  • Spencer LM, Alison JA, McKeough ZJ. Do supervised weekly exercise programs maintain functional exercise capacity and quality of life, twelve months after pulmonary rehabilitation in COPD? BMC Pulm Med. 2007 May 16;7:7. doi: 10.1186/1471-2466-7-7.

  • Sleszynski SL, Kelso AF. Comparison of thoracic manipulation with incentive spirometry in preventing postoperative atelectasis. J Am Osteopath Assoc. 1993 Aug;93(8):834-8, 843-5.

  • Fei F, J Siegert R, Zhang X, Gao W, Koffman J. Symptom clusters, associated factors and health-related quality of life in patients with chronic obstructive pulmonary disease: A structural equation modelling analysis. J Clin Nurs. 2023 Jan;32(1-2):298-310. doi: 10.1111/jocn.16234. Epub 2022 Jan 30.

  • O'Donnell DE, Milne KM, James MD, de Torres JP, Neder JA. Dyspnea in COPD: New Mechanistic Insights and Management Implications. Adv Ther. 2020 Jan;37(1):41-60. doi: 10.1007/s12325-019-01128-9. Epub 2019 Oct 30.

  • Koch J, Tsui C, Talsma J, Pierce-Talsma S. Osteopathic Manipulative Treatment for Inhaled Rib Somatic Dysfunction. J Am Osteopath Assoc. 2020 Jul 28. doi: 10.7556/jaoa.2020.109. Online ahead of print. No abstract available.

  • 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.

  • Marizeiro DF, Florencio ACL, Nunes ACL, Campos NG, Lima POP. Immediate effects of diaphragmatic myofascial release on the physical and functional outcomes in sedentary women: A randomized placebo-controlled trial. J Bodyw Mov Ther. 2018 Oct;22(4):924-929. doi: 10.1016/j.jbmt.2017.10.008. Epub 2017 Oct 25.

  • Halpin DM, Miravitlles M, Metzdorf N, Celli B. Impact and prevention of severe exacerbations of COPD: a review of the evidence. Int J Chron Obstruct Pulmon Dis. 2017 Oct 5;12:2891-2908. doi: 10.2147/COPD.S139470. eCollection 2017.

  • Global Initiative for chronic obstructive lung disease (GOLD).

    RESULT
  • Ragab K. Elnaggar PhD & Mohammed A. Shendy Bulletin of Faculty of Physical Therapy

    RESULT
  • Feizi H, Alizadeh M, Nejadghaderi SA, Noori M, Sullman MJM, Ahmadian Heris J, Kolahi AA, Collins GS, Safiri S. The burden of chronic obstructive pulmonary disease and its attributable risk factors in the Middle East and North Africa region, 1990-2019. Respir Res. 2022 Nov 19;23(1):319. doi: 10.1186/s12931-022-02242-z.

  • Bordoni B. Lymphatic Pump Manipulation in Patients with Chronic Obstructive Pulmonary Disease. Cureus. 2019 Mar 11;11(3):e4232. doi: 10.7759/cureus.4232.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • SHERIN Hassan, PROF.DR.

    FACULTY OF PHYSICAL THERAPY Beni suef university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

February 24, 2025

First Posted

March 10, 2025

Study Start

March 20, 2025

Primary Completion

September 20, 2025

Study Completion

October 20, 2025

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations