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

NCT01058213 | Completed Phase 2

• 1 other identifier: NR010249
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Pulmonary rehabilitation; Resistance Training; Aerobic Training; Dyspnea

Outcome Measures

Primary Outcomes (2)

• functional capacity for aerobic exercise and for common daily activities

  baseline, 16 weeks

• functional reserve as measured by the reduction in breathlessness and fatigue

  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

  baseline, 16 weeks

Study Arms (3)

Aerobic training alone

ACTIVE COMPARATOR

8 weeks of gentle chair (sham) training followed by 8 weeks of interval aerobic training on a stationary bicycle

Behavioral: Aerobic training

Sequential Resistance then Aerobic Training

EXPERIMENTAL

8 weeks of resistance training of the lower body followed by 8 weeks of interval aerobic training on a stationary bicycle

Behavioral: Resistance training; Behavioral: Aerobic training

Concurrent resistance and aerobic training

ACTIVE COMPARATOR

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

Behavioral: Resistance training; Behavioral: Aerobic training

Interventions

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.

Concurrent resistance and aerobic training; Sequential Resistance then Aerobic Training

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.

Aerobic training alone; Concurrent resistance and aerobic training; Sequential Resistance then Aerobic Training

Eligibility Criteria

• Age: 46 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 24958605 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Margaret K Covey, PhD, RN

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 28, 2010
• Study Start: November 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 18, 2013

Record last verified: 2013-12

Locations

US (1)