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Clinical Trials/NCT01631019
NCT01631019
Completed
Phase 2

Influence of Long-term Cell-phone Based Home Exercise on Biomarkers, Skeletal Muscle and Mortality in Patients With COPD

Chang Gung Memorial Hospital1 site in 1 country26 target enrollmentStarted: January 2007Last updated:

Overview

Phase
Phase 2
Status
Completed
Sponsor
Chang Gung Memorial Hospital
Enrollment
26
Locations
1
Primary Endpoint
inflammatory cytokines

Overview

Brief Summary

Background: Moderate-intensity exercise training improves skeletal muscle aerobic capacity and increased oxidative enzyme activity, as well as exercise tolerance in Chronic Obstructive Pulmonary Disease (COPD) patients.

Design: To investigate the home-based exercise training program can reduce inflammatory biomarkers in COPD.

Setting: Conducted from January 2007 to December 2007 at a tertiary medical center, Chang Gung Memorial Hospital, Taiwan.

Patients: Moderate to severe COPD receiving home exercise training, 12 using mobile phone assistance and 14 with free walk, were assessed for 6 months.

Measurements: Incremental shuttle walk test (ISWT), spirometry, strength of limb muscles, C-reactive protein (CRP) and inflammatory cytokines.

Detailed Description

Exercise training is the cornerstone of comprehensive rehabilitation programs in patients with COPD. Exercise training improves skeletal muscle oxidative capacity and efficiency that leads to a less alveolar ventilation at a given work rate. Patients can tolerate a heavier work load with less dyspnea under exercise. To date, it remains unclear whether and to what extent markers of low-grade systemic inflammation may affect trainability in clinically stable patients. Although specific exercise modalities can be applied to reverse muscle dysfunction, exercise intolerance, and reduced health-related quality of life, there is a substantial heterogeneity in the response to exercise training among patients with clinically stable COPD. Endurance exercise training has been reported to have consistently high clinical efficacy. Most pulmonary rehabilitation programs are hospital based and ask patients with regular supervision and monitoring in order to achieve persistent and optimal physiological benefits. However, compliance and time consuming with regular visits to the hospital or clinics are major stumbling blocks to the success of these programs. Recently, the investigators have developed a home-based exercise training program for stable COPD patients by asking them to walk at a speed controlled by the tempo of music from a program installed in a mobile phone. The tempo of music was set to keep the same walking speed at the intended level for endurance exercise training for all patients. Our mobile phone-based system provides an efficient home endurance exercise training program with good compliance and clinical outcomes in patients with moderate-to-severe COPD. This study was therefore designed to further explore whether the circulating level of inflammatory markers, such as CRP, IL-6, TNF-α, and IL-8, will be reduced in patients with COPD undergoing a mobile-phone assisted home-based exercise training program

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients with moderate to severe COPD

Exclusion Criteria

  • requirement for oxygen therapy;
  • presence of symptomatic cardiovascular diseases or severe systemic diseases limiting exercise capacity;
  • use of medications affecting exercise responses;
  • musculoskeletal conditions with exercise performance limitation; and
  • impaired hearing or vision that affects subject's ability to follow the exercise training program.

Outcomes

Primary Outcomes

inflammatory cytokines

Time Frame: 6 months

IL-8

C-reactive protein (CRP)

Time Frame: 6 months

CRP as systemic inflamatory status

Incremental shuttle walk test (ISWT)

Time Frame: 6 months

Distence of shuttle walking test!

spirometry

Time Frame: 6 months

FEV1 and FEV1/FVC.

strength of limb muscles

Time Frame: 6 months

upper and lower limbs stregth

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chang Gung Memorial Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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