Back to resultsNurse Managed Sequential Strength Training and Bicycle Training in Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Resistance training
Aerobic training
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Pulmonary rehabilitation, Resistance Training, Aerobic Training, Dyspnea
Eligibility Criteria
Inclusion Criteria:
- FEV1/FVC < 70 and FEV1 < 55%,
- > 45 years of age,
- experience dyspnea with exertion,
- stable clinical condition (Stable clinical condition is defined as free of respiratory tract infections for at least two months prior to enrollment, no recent change in the color, consistency, or quantity of sputum, afebrile and no recent change in medical therapy.)
Exclusion Criteria:
- evidence of restrictive lung disease or asthma,
- acute respiratory infection,
- taking oral corticosteroids on a regular basis,
- >3 exacerbations in the previous year,
- currently participating in pulmonary rehabilitation,
- the presence of a potentially debilitating disease or the presence of a condition that would make it potentially unsafe to exercise.
- We will adhere to the American College of Sports Medicine guidelines and exclude those who do not meet their guidelines for exercise testing and training.
- Pregnant women or women who plan to become pregnant during the study.
Sites / Locations
- University of Illinois at Chicago
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
Aerobic training alone
Sequential Resistance then Aerobic Training
Concurrent resistance and aerobic training
Arm Description
8 weeks of gentle chair (sham) training followed by 8 weeks of interval aerobic training on a stationary bicycle
8 weeks of resistance training of the lower body followed by 8 weeks of interval aerobic training on a stationary bicycle
8 weeks of gentle chair (sham) exercise followed by 8 weeks of concurrent resistance training of the lower body and interval aerobic training on a stationary bicycle
Outcomes
Primary Outcome Measures
functional capacity for aerobic exercise and for common daily activities
functional reserve as measured by the reduction in breathlessness and fatigue
Secondary Outcome Measures
functional performance and functional capacity utilization as measured by the Functional Performance Inventory and the CHAMPS Physical Activity Scale for Older Adults
Full Information
NCT ID
NCT01058213
First Posted
January 26, 2010
Last Updated
December 17, 2013
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT01058213
Brief Title
Nurse Managed Sequential Strength Training and Bicycle Training in Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Nurse Managed Sequential Resistance Then Aerobic Training in COPD
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a 16 week exercise training program for people with severe to very severe chronic obstructive pulmonary disease (COPD). The purpose of this study is to find out if performing strength training prior to initiating exercise training on a stationary bicycle is associated with greater gains in functional status than bicycle training alone or concurrent bicycle and strength training together.
Detailed Description
Volunteers are randomly assigned to one of three groups: 1). 8 weeks of resistance (strength) training followed by 8 weeks of bicycle exercise training, 2). 8 weeks of chair exercise followed by 8 weeks of resistance (strength) training and bicycle exercise training, or 3). 8 weeks of chair exercise followed by 8 weeks of bicycle exercise training. The length of the training is 16 weeks for all 3 groups. Volunteers train 3 days per week in our lab located in the Chicagoland area and are supervised by an exercise specialist.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Pulmonary rehabilitation, Resistance Training, Aerobic Training, Dyspnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
354 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic training alone
Arm Type
Active Comparator
Arm Description
8 weeks of gentle chair (sham) training followed by 8 weeks of interval aerobic training on a stationary bicycle
Arm Title
Sequential Resistance then Aerobic Training
Arm Type
Experimental
Arm Description
8 weeks of resistance training of the lower body followed by 8 weeks of interval aerobic training on a stationary bicycle
Arm Title
Concurrent resistance and aerobic training
Arm Type
Active Comparator
Arm Description
8 weeks of gentle chair (sham) exercise followed by 8 weeks of concurrent resistance training of the lower body and interval aerobic training on a stationary bicycle
Intervention Type
Behavioral
Intervention Name(s)
Resistance training
Intervention Description
Supervised training will be performed on a cable exercise system (Body Solid, Forest Park, IL) using six exercises that involve concentric and eccentric muscle actions: leg press, knee flexion, knee extension, calf raise, hip adduction, hip abduction. Subjects will perform the lower extremity exercises under the direct supervision of an exercise specialist three times per week. Subjects will perform 2 sets of 8-10 repetitions at 70% of their maximum strength for 2 weeks, then will perform 2 sets of 8-10 repetitions at 80% of their maximal strength for 2 weeks, and for the next 4 weeks they will perform 3 sets of 8-10 repetitions at 80% of their maximal strength. Sets will be separated by at least a 2-3 minute rest period for multiple-joint exercises and at least 1-2 minutes for single-joint exercises. A moderate velocity of muscle contraction (~1-2 seconds for concentric and eccentric contraction) will be used.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic training
Intervention Description
Cycle ergometry training will be performed in the lab on a stationary cycle ergometer, calibrated with a 4 kg weight (Monark 828E, Varberg, Sweden). Initial work rate will be 50% of peak work rate (PWR) as tolerated and will be evaluated weekly with progressive increases targeted to achieve the highest work rate tolerated for 3-5 minutes{: wks 1-2 50% PWR, wks 3-4 60% PWR, wks 5-6 70% PWR, wks 7-8 80% PWR}. An interval training protocol will be used with subjects performing four work sets of five minutes duration separated by rest intervals of unloaded cycling lasting 2-4 minutes.
Primary Outcome Measure Information:
Title
functional capacity for aerobic exercise and for common daily activities
Time Frame
baseline, 16 weeks
Title
functional reserve as measured by the reduction in breathlessness and fatigue
Time Frame
baseline, 16 weeks
Secondary Outcome Measure Information:
Title
functional performance and functional capacity utilization as measured by the Functional Performance Inventory and the CHAMPS Physical Activity Scale for Older Adults
Time Frame
baseline, 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
FEV1/FVC < 70 and FEV1 < 55%,
> 45 years of age,
experience dyspnea with exertion,
stable clinical condition (Stable clinical condition is defined as free of respiratory tract infections for at least two months prior to enrollment, no recent change in the color, consistency, or quantity of sputum, afebrile and no recent change in medical therapy.)
Exclusion Criteria:
evidence of restrictive lung disease or asthma,
acute respiratory infection,
taking oral corticosteroids on a regular basis,
>3 exacerbations in the previous year,
currently participating in pulmonary rehabilitation,
the presence of a potentially debilitating disease or the presence of a condition that would make it potentially unsafe to exercise.
We will adhere to the American College of Sports Medicine guidelines and exclude those who do not meet their guidelines for exercise testing and training.
Pregnant women or women who plan to become pregnant during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret K Covey, PhD, RN
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24958605
Citation
Covey MK, Collins EG, Reynertson SI, Dilling DF. Resistance training as a preconditioning strategy for enhancing aerobic exercise training outcomes in COPD. Respir Med. 2014 Aug;108(8):1141-52. doi: 10.1016/j.rmed.2014.06.001. Epub 2014 Jun 11.
Results Reference
derived
Learn more about this trial
Nurse Managed Sequential Strength Training and Bicycle Training in Chronic Obstructive Pulmonary Disease (COPD)
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