NCT02383277

Brief Summary

Investigate the effects of stretching the muscles of the rib cage in individuals with COPD during exercise.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

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

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

February 13, 2015

Last Update Submit

August 7, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Endurance tolerance as measured by the duration of the exercise

    Participants will be followed for the duration of the exercise, an expected average of 10 minutes

  • Dyspnea as measured by Borg Escale

    Participants will be followed for the duration of the exercise, an expected average of 10 minutes

Secondary Outcomes (3)

  • Diaphragm mobility measured by ultrasound

    Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes

  • Volumes of the chest wall measured by pletismography optoelectronic

    Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes

  • Muscle electrical activity measured by surface electromyography

    Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes

Study Arms (2)

Stretching and Exercise

EXPERIMENTAL

This group undergo a session of stretching aiming flexibility of the rib cage and later at an exercise test with constant load up to the limit of tolerance for exercise bike

Other: StretchingOther: Exercise

Control and Exercise

SHAM COMPARATOR

This group will carry out the exercise test with constant load up to the limit of tolerance for exercise bike after a period of rest under the same environmental conditions and the experimental group time. During this time the therapist will place their hands but not performing the stretch.

Other: ControlOther: Exercise

Interventions

Stretching of the rib cage muscles

Stretching and Exercise
ControlOTHER

Rest without stretching (sham)

Control and Exercise

Constant load exercise on a bike

Control and ExerciseStretching and Exercise

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoking history, occupational or environmental exposure to pollutants and / or symptoms of cough, dyspnea or hypersecretion;
  • FEV1 \<80% predicted and post-bronchodilator FEV1 / FVC \<70% to confirm the diagnosis of airway obstruction not fully reversible bronchodilator therapy;
  • Absence of co-morbidities that does not allow the realization of stress (hypertension, severe pulmonary hypertension, myocardial infarction, congestive heart failure, severe dyspnoea);
  • Preserved cognitive functioning;
  • Sedentary
  • Clinically stable during the study period.

You may not qualify if:

  • Patients with cognitive, hearing or visual deficit;
  • Changes in the neuro-musculo-skeletal system which endangers or impairs the assessment;
  • Obese
  • Not be able to achieve at least three stages of the incremental test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Adriane Cardim, Graduated

    Universidade Federal de Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Degree in Physical Therapy

Study Record Dates

First Submitted

February 13, 2015

First Posted

March 9, 2015

Study Start

November 1, 2014

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

August 11, 2015

Record last verified: 2015-08