Results of Manual Therapy on Pulmonary Parameters

November 2, 2016 updated by: Marie Carmen Valenza, Universidad de Granada

Manual Therapy Results on Pulmonary Function and Musculoskeletal Movement

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain
        • Faculty of Health Sciences. University of Granada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • subjects with acute processes in their pathologies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
30 people are recruited in order to the inclusion criteria for the study. Placebo controlled.
Other: Placebo
Usual care
Other Names:
  • 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 Names:
  • Manual therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
spirometry parameters
Time Frame: Baseline, 6 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thoracic movement
Time Frame: at baseline, 6 months
Changes from baseline to postintervention in thoracic movement, measured by tape measure in 3 thoracic levels.
at baseline, 6 months
Changes on Functionality scores
Time Frame: baseline, 6 months
Functional status questionnaire used before and after intervention to measure functionality scores change.
baseline, 6 months
Changes on cardiorespiratory capacity
Time Frame: baseline, 6 months
Changes on cardiorespiratory capacity measured by 6MWT (6 minutes walking test)at baseline and post intervention.
baseline, 6 months
spinal movement
Time Frame: at baseline, 6 months
Changes from baseline to postintervention in spinal movement, measured by Range of motion with goniometer.
at baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Investigators

  • Principal Investigator: Carmen M Valenza, PH MD, Universidad de Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF0035UG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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