NCT02036762

Brief Summary

THE AIM OF THIS STUDY IS TO TEST IF THE STRETCHING OF THE RESPIRATORY ACCESSORY MUSCLE PROVIDE SOME BENEFIT ON THORACOABDOMINAL MECHANICS, FUNCTIONAL CAPACITY, PSYCHOLOGICAL AND SOCIAL ASPECTS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

3 active sites

Status
completed

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

November 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
Last Updated

January 15, 2014

Status Verified

January 1, 2014

Enrollment Period

2.2 years

First QC Date

August 15, 2013

Last Update Submit

January 13, 2014

Conditions

DyspneaQuality of LifeRespiratory Symptoms

Keywords

Chronic Obstructive Pulmonary DiseaseThoracoabdominal MechanicsFunctional capacityQuality of life

Outcome Measures

Primary Outcomes (1)

  • Functional Capacity

    Distance obtained (in meters) during six minutes walking test

    One week after the end of training

Secondary Outcomes (1)

  • Thoracoabdominal mechanics

    One week after the end of training

Other Outcomes (1)

  • Anxiety and depression

    One week after the end of training

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

The group submitted to stretching exercises in the respiratory muscles and treadmill exercises

Other: Stretching Exercises

Control Group

SHAM COMPARATOR

The control group received stretching exercises in the fist and ankle muscles and treadmill exercises

Other: Stretching Exercises

Interventions

Stretching ExercisesOTHER

The group submitted to stretching exercises in the respiratory muscles and treadmill exercises

Control GroupTreatment Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Obstructive Pulmonary Disease Diagnosis
  • Clinical stability
  • Absence of previous thoracic surgery
  • Absence of other limitations

You may not qualify if:

  • Copd exacerbation
  • Absence greater than three days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Physiotherapy Departament of University of São Paulo

São Paulo, São Paulo, 05360-000, Brazil

Location

FOFITO

São Paulo, São Paulo, 05360000, Brazil

Location

Hospital das Clinicas

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

DyspneaSigns and Symptoms, RespiratoryPulmonary Disease, Chronic Obstructive

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Celso Carvalho, Dr.

    Physiotherapy Departament of University of São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Degree (in process)

Study Record Dates

First Submitted

August 15, 2013

First Posted

January 15, 2014

Study Start

November 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 15, 2014

Record last verified: 2014-01

Locations

BR(3)