Nurse Managed Sequential Strength Training and Bicycle Training in Chronic Obstructive Pulmonary Disease (COPD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Margaret K. Covey, University of Illinois
ClinicalTrials.gov Identifier:
NCT01058213
First received: January 26, 2010
Last updated: December 5, 2012
Last verified: December 2012

January 26, 2010
December 5, 2012
November 2008
May 2013   (final data collection date for primary outcome measure)
  • functional capacity for aerobic exercise and for common daily activities [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
  • functional reserve as measured by the reduction in breathlessness and fatigue [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01058213 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Nurse Managed Sequential Strength Training and Bicycle Training in Chronic Obstructive Pulmonary Disease (COPD)
Nurse Managed Sequential Resistance Then Aerobic Training in COPD

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Behavioral: Resistance training
    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.
  • Behavioral: Aerobic training
    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.
  • Active Comparator: Aerobic training alone
    8 weeks of gentle chair (sham) training followed by 8 weeks of interval aerobic training on a stationary bicycle
    Intervention: Behavioral: Aerobic training
  • Experimental: Sequential Resistance then Aerobic Training
    8 weeks of resistance training of the lower body followed by 8 weeks of interval aerobic training on a stationary bicycle
    Interventions:
    • Behavioral: Resistance training
    • Behavioral: Aerobic training
  • Active Comparator: Concurrent resistance and aerobic training
    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
    Interventions:
    • Behavioral: Resistance training
    • Behavioral: Aerobic training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
46 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01058213
NR010249
No
Margaret K. Covey, University of Illinois
University of Illinois
Not Provided
Principal Investigator: Margaret K Covey, PhD, RN University of Illinois
University of Illinois
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP