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Completed

NCT Number: NCT01058213

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

46 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resistance training

Behavioral

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.

Aerobic training

Behavioral

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 outcomes

  1. functional capacity for aerobic exercise and for common daily activities

    Time frame: baseline, 16 weeks

  2. functional reserve as measured by the reduction in breathlessness and fatigue

    Time frame: baseline, 16 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

Nurse Managed Sequential Resistance Then Aerobic Training in COPD

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2010
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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