Results of Manual Therapy on Pulmonary Parameters

This study is currently recruiting participants.
Verified January 2014 by Universidad de Granada
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01735474
First received: November 5, 2012
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Respiratory Disease
Other: Manual technique
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Manual Therapy Results on Pulmonary Function and Musculoskeletal Movement

Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • spirometry parameters [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • thoracic movement [ Time Frame: at baseline, 6 months ] [ Designated as safety issue: Yes ]
    Changes from baseline to postintervention in thoracic movement, measured by tape measure in 3 thoracic levels.

  • Changes on Functionality scores [ Time Frame: baseline, 6 months ] [ Designated as safety issue: Yes ]
    Functional status questionnaire used before and after intervention to measure functionality scores change.

  • Changes on cardiorespiratory capacity [ Time Frame: baseline, 6 months ] [ Designated as safety issue: Yes ]
    Changes on cardiorespiratory capacity measured by 6MWT (6 minutes walking test)at baseline and post intervention.

  • spinal movement [ Time Frame: at baseline, 6 months ] [ Designated as safety issue: Yes ]
    Changes from baseline to postintervention in spinal movement, measured by Range of motion with goniometer.


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
30 people are recruited in order to the inclusion criteria for the study. Placebo controlled.
Other: Placebo
Usual care
Other Name: No intervention
Active Comparator: Manual technique
30 people are recruited in order to the inclusion criteria for the study. Experimental group.
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.

Other Name: Manual therapy.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • subjects with respiratory conditions
  • Must be able to do spirometry

Exclusion Criteria:

  • subjects with acute processes in their pathologies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735474

Contacts
Contact: Marie Carmen Valenza cvalenza@ugr.es

Locations
Spain
Faculty of health Sciences. University of Granada Recruiting
Granada, Spain
Principal Investigator: Marie Carmen Valenza         
Sponsors and Collaborators
Universidad de Granada
Investigators
Principal Investigator: Carmen M Valenza, PH MD Universidad de Granada
  More Information

No publications provided

Responsible Party: Marie Carmen Valenza, assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01735474     History of Changes
Other Study ID Numbers: DF0035UG
Study First Received: November 5, 2012
Last Updated: January 21, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad de Granada:
manual therapy
respiratory disease
thoracic movement

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014