NCT03022942

Brief Summary

To evaluate the acute and chronic effects of costal mobilization techniques and diaphragmatic release in chest cavity kinematics, diaphragmatic mobility and functional capacity 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
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

December 22, 2016

Last Update Submit

February 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mobility of the thoracic cage

    Will be measured by optoelectronic plestimography

    Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)

Secondary Outcomes (3)

  • Diaphragma mobility

    Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)

  • functional capacity

    Three weeks total: after two weeks of intervention and after one week without treatment (follow up)

  • heart rate variability

    1 day: before and after the intervention

Study Arms (2)

Costal mobilization & Diaphragm Release

EXPERIMENTAL

Costal mobilization. Lying: two sets of ten deep respiratory cycles with one minute interval between sets. Sitting: two series with interval of one minute between them. Manual Diaphragm Release Technique: will be applied during two series of ten deep respiratory cycles, with one minute interval between sets.

Other: GROUP Costal mobilization & Diaphragm Release

Manual Diaphragm Release

ACTIVE COMPARATOR

Manual Diaphragm Release Technique: will be applied during two series of ten deep respiratory cycles, with one minute interval between sets.

Other: GROUP Manual Diaphragm Release

Interventions

Costal mobilization technique (Rib raising): The patient will be lying. The Therapist supports the last four pulps of both hands at the rib angles, gently traverses the rib angles in the posterior-anterior direction, using the stretcher as a lever to facilitate the elevation of the costal angles. Siting: The Therapist hugs the patient by supporting the ribs of the fingers at the rib angles, gently traverses the rib angles bilaterally in the anterior-lateral direction. Manual Diaphragm Release Technique: The therapist makes manual contact with the underside of the costal border of the common cartilage of the last rib. In the inspiratory phase, the therapist draws the points of contact with both hands in a cephalad direction and slightly Accompanying the movement of the rib cage.

Also known as: GROUP Rib Raising & Diaphragm Release, GROUP A
Costal mobilization & Diaphragm Release

The therapist makes manual contact with the underside of the costal border of the common cartilage of the last rib. In the inspiratory phase, the therapist draws the points of contact with both hands in a cephalad direction and slightly Accompanying the movement of the rib cage.

Also known as: GROUP B
Manual Diaphragm Release

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of COPD (spirometry with FEV1 \<80% and FEV1 / FVC \<0.7) of both sexes, who are not undergoing another physiotherapeutic treatment, from to 21 years of age, clinically stable without exacerbation in the last 6 weeks.

You may not qualify if:

  • Patients with rheumatic or orthopedic diseases;
  • Deformities / abnormalities in the spine that compromise the mechanics of the respiratory system;
  • Rib fracture for less than 1 year;
  • Respiratory co-morbidities;
  • History of thoracic or abdominal surgery for less than 1 year;
  • Osteoporosis and IMC \> 30kg / m²

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

Location

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

  • HELENA M ROCHA

    Universidade Federal de Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate

Study Record Dates

First Submitted

December 22, 2016

First Posted

January 18, 2017

Study Start

February 1, 2017

Primary Completion

January 31, 2018

Study Completion

November 30, 2018

Last Updated

February 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations