NCT02860728

Brief Summary

Structural changes in skeletal muscles of patients with chronic obstructive pulmonary disease (COPD) have been linked to impaired muscle function, reduced exercise capacity, and increased mortality associated with this disease. Muscle dysfunction also contributes to dyspnea intensity and the ability to sustain exercise, making aerobic exercise training intolerable at the intensity and/or volume required to achieve clinically important changes. Resistance training (RT) is an attractive exercise modality because it is efficacious and more tolerable initially. No work has examined whether a short-term RT program can reduce exertional symptoms and improve exercise tolerance (dyspnea and leg fatigue) in patients with COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

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

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

3.5 years

First QC Date

August 5, 2016

Last Update Submit

June 9, 2022

Conditions

Keywords

COPDResistance TrainingExercise TrainingDyspnea

Outcome Measures

Primary Outcomes (1)

  • Dyspnea

    The change in the sensory intensity of dyspnea measured at an iso-time during the constant load exercise trials post RT

    Baseline and post 4 weeks (12 sessions) of resistance training

Secondary Outcomes (4)

  • Exercise Tolerance

    Baseline and post 4 weeks (12 sessions) of resistance training

  • Secondary Dyspnea Outcomes

    Baseline and post 4 weeks (12 sessions) of resistance training

  • Quadriceps Fatigue

    Baseline and post 4 weeks (12 sessions) of resistance training

  • Muscle Strength and Endurance

    Baseline and post 4 weeks (12 sessions) of resistance training

Study Arms (1)

Resistance training

EXPERIMENTAL

Patients with COPD will participate in 4 weeks (12 sessions) of individualized, non-linear, lower body resistance training.

Behavioral: Individualized Resistance Training

Interventions

Lower body resistance exercises will be prescribed in various combinations over multiple days and individually modified and progressed to achieve advances in both movement pattern, intensity, and exercise volume.

Resistance training

Eligibility Criteria

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

You may qualify if:

  • Non-smokers \>6 months
  • FEV1/FVC \<0.7 and lower limit of normal
  • %\< FEV1 pred \<70%
  • Stable (no exacerbation for \>3 months)

You may not qualify if:

  • Cardiovascular and cerebrovascular disease
  • Diabetes
  • Cardiovascular contraindications to exercise
  • Uncontrolled hypertension
  • Currently performing regular structured exercise \>3x/week for 30 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V 1V7, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

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

Study Officials

  • Neil Eves, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 9, 2016

Study Start

August 1, 2016

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

June 13, 2022

Record last verified: 2022-06

Locations