NCT02047370

Brief Summary

Physical therapists have traditionally included various forms of manual therapy among the therapeutic approaches to respiratory conditions. The aim of this study was to evaluate the effect of diaphragmatic stretching technique on pulmonary ventilation, rig bage excursion and spirometric values in patients diagnosed with asthma.

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 asthma

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable asthma

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

2.8 years

First QC Date

January 22, 2014

Last Update Submit

December 3, 2015

Conditions

Keywords

stretching, diaphragm, asthma, manual therapy

Outcome Measures

Primary Outcomes (1)

  • Forced vital capacity

    The amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. It is going to be measured using a spirometer as recommended by the American Thoracic Society.

    Baseline, 7 days

Secondary Outcomes (4)

  • Abdominal Kinematics

    baseline, 7 days

  • Airway diffusing capacity

    baseline, 7 days

  • Forced expiratory volume in the first second

    baseline, 7 days

  • Rib cage excursion

    baseline, 7 days

Study Arms (2)

Diaphragm stretching

EXPERIMENTAL

30 Patients with asthma are included in this group. They will receive a diaphragm stretching technique

Other: Diaphragm stretching

Placebo group

PLACEBO COMPARATOR

Ultrasound disconnected in same position and with the same duration.

Other: Placebo

Interventions

The therapist stands behind the patient and passes his hands around the thoracic cage, carefully introducing fingers under the costal margins. The patient slightly rounds the trunk in order to relax rectus abdominis. During the exhalation of the patient the therapist grasps the lower ribs and costal margin and eases the hands caudally. This traction was maintained during 5-7 minutes.

Also known as: Manual therapy
Diaphragm stretching
PlaceboOTHER

The same therapist, patient position and duration of the technique, but using disconnected ultrasound

Also known as: Disconnected ultrasound.
Placebo group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ranging between 18 and 45 years.
  • Diagnosis of asthma.
  • No exacerbations during last month.

You may not qualify if:

  • History of spine surgery.
  • Diabetes, neurological or a cardiovascular disease.
  • Spine deformities and use of orthopedic devices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of health Sciences. University of Granada

Granada, Spain, 18071, Spain

Location

MeSH Terms

Conditions

Asthma

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Marie Carmen Valenza, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 28, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations