Results of Manual Therapy on Pulmonary Parameters

Respiratory Disease Clinical Trial

Official title:

Manual Therapy Results on Pulmonary Function and Musculoskeletal Movement

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01735474
• Other study ID #: DF0035UG
• Status: Suspended
• Phase: N/A
• First received: November 5, 2012
• Last updated: November 2, 2016
• Start date: November 2012
• Est. completion date: April 2017

Study information

• Verified date: November 2016
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to evaluate the effectiveness of different manual techniques included traditionally on respiratory physical therapy

Description:

Randomized controlled trial. Participants are classified in two groups and they are assessed using pulmonary functions parameters and thoracic and spinal movements.

There are two interventions: placebo and a manual technique. Participants will be assessed again at the end of the study.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: April 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• subjects with respiratory conditions

• Must be able to do spirometry

Exclusion Criteria:

• subjects with acute processes in their pathologies

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Other:
• Manual technique
A manual technique is employed in the intervention group based on passive movement and stretching of the respiratory system. The manual technique includes: stretching of diaphragm. Mobilization. Potentiation of the respiratory muscles.
• Placebo
Usual care

Locations

Country	Name	City	State
Spain	Faculty of health Sciences. University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spirometry parameters	Change from baseline to postintervention in spirometry parameters (Vital capacity, Forced expiratory volume in the first second (FEV1), Tidal volume)using a spirometer as recommended by the American Thoracic Society.	Baseline, 6 months	Yes
Secondary	thoracic movement	Changes from baseline to postintervention in thoracic movement, measured by tape measure in 3 thoracic levels.	at baseline, 6 months	Yes
Secondary	Changes on Functionality scores	Functional status questionnaire used before and after intervention to measure functionality scores change.	baseline, 6 months	Yes
Secondary	Changes on cardiorespiratory capacity	Changes on cardiorespiratory capacity measured by 6MWT (6 minutes walking test)at baseline and post intervention.	baseline, 6 months	Yes
Secondary	spinal movement	Changes from baseline to postintervention in spinal movement, measured by Range of motion with goniometer.	at baseline, 6 months	Yes