We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Results of Manual Therapy on Pulmonary Parameters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01735474
Recruitment Status : Suspended (Sample size was not completed)
First Posted : November 28, 2012
Last Update Posted : November 3, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Respiratory Disease Other: Manual technique Other: Placebo

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Manual Therapy Results on Pulmonary Function and Musculoskeletal Movement
Study Start Date : November 2012
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : April 2017
Arms and Interventions

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 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.

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. thoracic movement [ Time Frame: at baseline, 6 months ]
    Changes from baseline to postintervention in thoracic movement, measured by tape measure in 3 thoracic levels.

  2. Changes on Functionality scores [ Time Frame: baseline, 6 months ]
    Functional status questionnaire used before and after intervention to measure functionality scores change.

  3. 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.

  4. spinal movement [ Time Frame: at baseline, 6 months ]
    Changes from baseline to postintervention in spinal movement, measured by Range of motion with goniometer.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • subjects with acute processes in their pathologies
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735474

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

Responsible Party: Marie Carmen Valenza, assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01735474     History of Changes
Other Study ID Numbers: DF0035UG
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Marie Carmen Valenza, Universidad de Granada:
manual therapy
respiratory disease
thoracic movement

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases