NCT01735474

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

4.2 years

First QC Date

November 5, 2012

Last Update Submit

November 2, 2016

Conditions

Respiratory Disease

Keywords

manual therapyrespiratory diseasethoracic movement

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 6 months

Secondary Outcomes (4)

  • thoracic movement

    at baseline, 6 months

  • Changes on Functionality scores

    baseline, 6 months

  • Changes on cardiorespiratory capacity

    baseline, 6 months

  • spinal movement

    at baseline, 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Manual technique

ACTIVE COMPARATOR

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

Other: Manual technique

Interventions

Manual techniqueOTHER

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.

Also known as: Manual therapy.
Manual technique
PlaceboOTHER

Usual care

Also known as: No intervention
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • subjects with acute processes in their pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of health Sciences. University of Granada

Granada, Spain

Location

MeSH Terms

Conditions

Respiration Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Carmen M Valenza, PH MD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 28, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2017

Study Completion

April 1, 2017

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

ES(1)