Results of Manual Therapy on Pulmonary Parameters

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014