Comparison of Two Programs to Encourage Physical Activity in Individuals With Chronic Obstructive Pulmonary Disease

NCT00328484 | Completed Phase 3 DMC

• 2 other identifiers: 387R01HL053755-09
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease. Symptoms include shortness of breath, wheezing, and difficulty exercising. Increasing exercise and physical activity may relieve the symptoms of COPD and may also slow the progression of the disease. The purpose of this study is to evaluate the effectiveness of a lifestyle activity program versus a traditional exercise program at increasing the amount of physical activity among individuals with COPD.

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Keywords

COPD; Chronic Obstructive Pulmonary Disease; Exercise; Emphysema; Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

• Amount of time engaged in moderate physical activity each week

  Measured at Year 1

Secondary Outcomes (4)

• Health related quality of life

  Measured at Year 1

• Self-reported disability

  Measured at Year 1

• Physical function

  Measured at Year 1

• Exercise capacity

  Measured at Year 1

Study Arms (2)

1

EXPERIMENTAL

Eleven month lifestyle activity program

Behavioral: Lifestyle Activity Program

2

ACTIVE COMPARATOR

Three month exercise program

Behavioral: Exercise Program

Interventions

Lifestyle Activity Program BEHAVIORAL

The lifestyle activity program will consist of 35 exercise and counseling sessions spaced over 11 months. This program will use cognitive-behavioral strategies to encourage physical activity at home. Participants will receive information on how to deal with COPD symptoms (including shortness of breath), goal-setting, social support, and motivation. Participants will also receive follow-up telephone calls from the program staff for additional support.

1

Exercise Program BEHAVIORAL

The 3-month exercise program will consist of 36 1-hour exercise training sessions, conducted 3 times a week for 12 weeks.

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Expiratory airflow limitation such that FEV1/FVC is less than or equal to 70% and the FEV₁ is greater than or equal to 20% of the predicted amount
• Physical disability, including self-reported difficulty with walking a city block, climbing stairs, lifting and carrying groceries, performing household activities such as cleaning and doing yard work, or getting out of a chair
• Currently lives within a 35-mile radius of Wake Forest University
• Plans to reside in Forsyth County, North Carolina for the entire study
• Willing and able to participate in all aspects of the trial

You may not qualify if:

• Undergoing treatment for cancer
• Severe congestive heart failure
• Stroke
• Peripheral vascular disease
• Coronary artery disease
• Valvular heart disease
• Major psychiatric disease
• Severe anemia
• Liver or kidney disease
• Uncontrolled diabetes or hypertension
• Orthopedic impairment
• Blindness or deafness
• Oxygen desaturation during exercise to less than 90%, at a heart rate less than 50% of predicted maximum for participant's age and without supplemental oxygen
• Inability to exercise due to a physical disability or positive exercise stress test
• Alcohol consumption of greater than two drinks per day in the 2 months prior to study entry

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

Related Publications (4)

• Foy CG, Wickley KL, Adair N, Lang W, Miller ME, Rejeski WJ, Woodard CM, Berry MJ. The Reconditioning Exercise and Chronic Obstructive Pulmonary Disease Trial II (REACT II): rationale and study design for a clinical trial of physical activity among individuals with chronic obstructive pulmonary disease. Contemp Clin Trials. 2006 Apr;27(2):135-46. doi: 10.1016/j.cct.2005.11.011. Epub 2006 Feb 2.

  PMID: 16458075 BACKGROUND

• Katula JA, Rejeski WJ, Wickley KL, Berry MJ. Perceived difficulty, importance, and satisfaction with physical function in COPD patients. Health Qual Life Outcomes. 2004 Mar 31;2:18. doi: 10.1186/1477-7525-2-18.

  PMID: 15056389 BACKGROUND

• Berry MJ, Adair NE, Rejeski WJ. Use of peak oxygen consumption in predicting physical function and quality of life in COPD patients. Chest. 2006 Jun;129(6):1516-22. doi: 10.1378/chest.129.6.1516.

  PMID: 16778269 BACKGROUND

• Berry MJ, Rejeski WJ, Miller ME, Adair NE, Lang W, Foy CG, Katula JA. A lifestyle activity intervention in patients with chronic obstructive pulmonary disease. Respir Med. 2010 Jun;104(6):829-39. doi: 10.1016/j.rmed.2010.02.015. Epub 2010 Mar 26.

  PMID: 20347286 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Motor Activity; Emphysema; Bronchitis, Chronic

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

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

• Michael J. Berry, PhD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 19, 2006
• First Posted: May 22, 2006
• Study Start: January 1, 2002
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: July 29, 2016

Record last verified: 2009-02

Locations

US (1)