NCT03417908

Brief Summary

To evaluate the activation of accessory respiratory muscles and the effects of stretching these muscles in patients with COPD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

December 4, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2018

Completed
Last Updated

November 26, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

January 24, 2018

Last Update Submit

November 22, 2018

Conditions

COPD

Keywords

Proprioceptive neuromuscular facilitationPulmonary Rehabilitationmuscle activationCOPD

Outcome Measures

Primary Outcomes (1)

  • Change in inspiratory capacity

    Change in inspiratory capacity

    One day

Secondary Outcomes (2)

  • Change in maximal respiratory pressure (MIP and MEP)

    One day

  • Change in electromyographic activity of accessory respiratory muscles

    One Day

Study Arms (4)

COPD - PNF

ACTIVE COMPARATOR

COPD - PNF

Procedure: PNF

COPD - sham

SHAM COMPARATOR

COPD - sham

Procedure: Sham

Individuals Without COPD - PNF

ACTIVE COMPARATOR

Individuals Without COPD - PNF

Procedure: PNF

Individuals Without COPD - sham

SHAM COMPARATOR

Individuals Without COPD - sham

Procedure: Sham

Interventions

PNFPROCEDURE

The contract-relax method of proprioceptive neuromuscular facilitation (PNF) technique will be used for stretching of ESC, ECM and external intercostals muscles. The contraction of agonist muscles against the resistance imposed by the physiotherapist (isometric contraction) will be maintained for 6 seconds. After that, the patient is oriented to relax the muscles for 6 seconds without losing range of motion, and then the muscle will be lengthened. This procedure is repeated until the maximum amplitude of motion of the neck and upper limb is reached. The stretching will be performed on the right and left sides of the body.

COPD - PNFIndividuals Without COPD - PNF
ShamPROCEDURE

Isotonic concentric contraction of the biceps (two sets of five push-ups elbow in both arms) with the individual sitting in a chair with back support.

COPD - shamIndividuals Without COPD - sham

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Control group: Men without respiratory symptoms and lung disease, with normal spirometry.
  • Interventional group: Men diagnosed with severe to very severe COPD (forced expiratory volume in one second / forced vital capacity - FEV1/FVC \<0.7 and FEV1 \<50% predicted after bronchodilator use); clinically stable over the past 4 weeks.

You may not qualify if:

  • History of fracture in the spine and / or upper limb
  • Herniated disc
  • Connective tissue disease
  • Ischemic heart disease or uncontrolled hypertension
  • Obesity (BMI\> 30 kg/m2)
  • Aortic aneurysm
  • Recent abdominal or thoracic surgery
  • Glaucoma
  • Retinal detachment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anelise Dumke

Uruguaiana, Rio Grande do Sul, 97502-765, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anelise Dumke

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

  • Marli M. Knorst

    Federal University of Rio Grande do Sul

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 24, 2018

First Posted

January 31, 2018

Study Start

December 4, 2017

Primary Completion

December 14, 2018

Study Completion

December 14, 2018

Last Updated

November 26, 2018

Record last verified: 2018-02

Locations

BR(1)