NCT01786928

Brief Summary

The purpose of this study is to determine whether resistance exercise are effective in combating the decline in muscle strength during an exacerbation of Chronic Obstructive Pulmonary Disease (COPD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

8 months

First QC Date

January 10, 2012

Last Update Submit

February 5, 2013

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary diseaseexacerbationresistance trainingmuscle force

Outcome Measures

Primary Outcomes (1)

  • The benefits of resistance training during exacerbation of COPD on peripheral muscle strength during hospitalization

    The metric used to evaluate the strength gain is given in kilogram (absolute value) and percentage relative to that obtained on the second hospital day

    Will be evaluated on the second day of hospitalization, the day of hospital discharge (this time interval must be longer than five days)

Secondary Outcomes (1)

  • The benefits of resistance training during exacerbation of COPD on physical activity in daily life

    Will be evaluated in the third and fifth day of hospitalization and thirty days after discharge

Study Arms (2)

resistance training

EXPERIMENTAL

resistance training of the upper and lower limbs, two series of 80% of repetition maximum test

Other: Resistance training

Control

NO INTERVENTION

Traditional Respiratory Therapy for bronchial hygiene

Interventions

Resistance trainingOTHER

Resistance training group received training program for upper (shoulder flexion and abduction and biceps) and lower limbs (knee extension and flexion and hip flexion). Daily exercise for every muscle was performed with free weights at 80% of an maximal repetition test and a 4 minutes rest was allowed between each step.

resistance training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients hospitalized for exacerbation of COPD

You may not qualify if:

  • patients presenting change in mental status (confusion, lethargy or coma)
  • persistence or worsening in hypoxemia (PaO2\<40mmHg) and/or respiratory acidosis (pH\<7.25) despite oxygen supplementation or use of non-invasive ventilation
  • hemodynamic instability requiring vasoactive drugs
  • patients transferred to ICU
  • hospitalization lower than 5 days
  • diseases that prevented the exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of sao paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

Related Publications (1)

  • Borges RC, Carvalho CR. Impact of resistance training in chronic obstructive pulmonary disease patients during periods of acute exacerbation. Arch Phys Med Rehabil. 2014 Sep;95(9):1638-45. doi: 10.1016/j.apmr.2014.05.007. Epub 2014 May 28.

    PMID: 24879965DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rodrigo C Borges, specialist

    school of Medicine university of sao paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD in physiology

Study Record Dates

First Submitted

January 10, 2012

First Posted

February 8, 2013

Study Start

April 1, 2009

Primary Completion

December 1, 2009

Study Completion

October 1, 2010

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

BR(1)