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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03022942
Other study ID # Lacap UFPE
Secondary ID
Status Recruiting
Phase N/A
First received December 22, 2016
Last updated April 9, 2018
Start date January 2017
Est. completion date December 2018

Study information

Verified date April 2018
Source Universidade Federal de Pernambuco
Contact HELENA M ROCHA
Email hmr.fisio@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Study will be a controlled clinical trial in which participants will be randomized into 2 groups: GROUP A (costal mobilization techniques and Manual Diaphragm Release Technique), GROUP B (Manual Diaphragm Release Technique). After the initial evaluation, participants will undergo six sessions of care according to randomization and will be reevaluated in 3 following situations: immediately after the first session, at the end of treatment and one week after the last session. The evaluation will be performed through Optoelectronic plethysmography , Pollar, Ultrasound and 6-minutes walk test.


Recruitment information / eligibility

Status Recruiting
Enrollment 14
Est. completion date December 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
GROUP Costal mobilization & Diaphragm Release
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.
GROUP Manual 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.

Locations

Country Name City State
Brazil Universidade Federal de Pernambuco Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Diaphragma mobility Will be measured with ultrasonography Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)
Secondary functional capacity Will be measured six minute walk test Three weeks total: after two weeks of intervention and after one week without treatment (follow up)
Secondary heart rate variability Will be measured Pollar 1 day: before and after the intervention
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