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Results of Manual Therapy on Pulmonary Parameters

Primary Purpose

Respiratory Disease

Status
Suspended
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual technique
Placebo
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Disease focused on measuring manual therapy, respiratory disease, thoracic movement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • subjects with acute processes in their pathologies

Sites / Locations

  • Faculty of health Sciences. University of Granada

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Manual technique

Arm Description

30 people are recruited in order to the inclusion criteria for the study. Placebo controlled.

30 people are recruited in order to the inclusion criteria for the study. Experimental group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 5, 2012
Last Updated
November 2, 2016
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT01735474
Brief Title
Results of Manual Therapy on Pulmonary Parameters
Official Title
Manual Therapy Results on Pulmonary Function and Musculoskeletal Movement
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Suspended
Why Stopped
Sample size was not completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease
Keywords
manual therapy, respiratory disease, thoracic movement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
30 people are recruited in order to the inclusion criteria for the study. Placebo controlled.
Arm Title
Manual technique
Arm Type
Active Comparator
Arm Description
30 people are recruited in order to the inclusion criteria for the study. Experimental group.
Intervention Type
Other
Intervention Name(s)
Manual technique
Other Intervention Name(s)
Manual therapy.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
No intervention
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
spirometry parameters
Description
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.
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
thoracic movement
Description
Changes from baseline to postintervention in thoracic movement, measured by tape measure in 3 thoracic levels.
Time Frame
at baseline, 6 months
Title
Changes on Functionality scores
Description
Functional status questionnaire used before and after intervention to measure functionality scores change.
Time Frame
baseline, 6 months
Title
Changes on cardiorespiratory capacity
Description
Changes on cardiorespiratory capacity measured by 6MWT (6 minutes walking test)at baseline and post intervention.
Time Frame
baseline, 6 months
Title
spinal movement
Description
Changes from baseline to postintervention in spinal movement, measured by Range of motion with goniometer.
Time Frame
at baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: subjects with respiratory conditions Must be able to do spirometry Exclusion Criteria: subjects with acute processes in their pathologies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen M Valenza, PH MD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of health Sciences. University of Granada
City
Granada
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Results of Manual Therapy on Pulmonary Parameters

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