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Mobile-phone-based Home Exercise in Chronic Obstructive Pulmonary Disease

Primary Purpose

Moderate to Severe COPD Receiving Home Exercise Training

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Mobile-phone-based Home Exercise Training Program
Home Exercise Training Program
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Moderate to Severe COPD Receiving Home Exercise Training focused on measuring Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Mobile phone, Biomarker

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

with mobile phone assistance

with free walk

Arm Description

In the mobile phone group, patients were asked to continue their exercise program at home at a fixed walking speed. During this period of time, the adherence to protocol was reinforced by telephone from health professionals whenever patients missed one day of their walking training detected by the central system. Patients were asked to continue their exercise program at home at a fixed walking speed, and return to the clinic at 1, 2, 3 and 6 months.

Patients in the control group were educated the same exercise protocol, but were only verbally asked to freely take the walking exercise training at home. The adherence to the walking exercise at home was reported by the patients themselves at every return visits. All the patients received ISWT, spirometry and blood sample for inflammatory biomarkers at baseline, 1, 2, 3 and 6 months.

Outcomes

Primary Outcome Measures

inflammatory cytokines
IL-8
C-reactive protein (CRP)
CRP as systemic inflamatory status
Incremental shuttle walk test (ISWT)
Distence of shuttle walking test!
spirometry
FEV1 and FEV1/FVC.
strength of limb muscles
upper and lower limbs stregth

Secondary Outcome Measures

Full Information

First Posted
June 26, 2012
Last Updated
July 4, 2012
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01631019
Brief Title
Mobile-phone-based Home Exercise in Chronic Obstructive Pulmonary Disease
Official Title
Influence of Long-term Cell-phone Based Home Exercise on Biomarkers, Skeletal Muscle and Mortality in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe COPD Receiving Home Exercise Training
Keywords
Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Mobile phone, Biomarker

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
with mobile phone assistance
Arm Type
Active Comparator
Arm Description
In the mobile phone group, patients were asked to continue their exercise program at home at a fixed walking speed. During this period of time, the adherence to protocol was reinforced by telephone from health professionals whenever patients missed one day of their walking training detected by the central system. Patients were asked to continue their exercise program at home at a fixed walking speed, and return to the clinic at 1, 2, 3 and 6 months.
Arm Title
with free walk
Arm Type
Placebo Comparator
Arm Description
Patients in the control group were educated the same exercise protocol, but were only verbally asked to freely take the walking exercise training at home. The adherence to the walking exercise at home was reported by the patients themselves at every return visits. All the patients received ISWT, spirometry and blood sample for inflammatory biomarkers at baseline, 1, 2, 3 and 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Mobile-phone-based Home Exercise Training Program
Intervention Description
Patients in the mobile phone group were asked to perform daily endurance exercise training under mobile phone guidance, and the adherence was reported back to the central server. The level of endurance walking was re-assessed and re-adjusted initially on regular clinical visits every four weeks during the first three months. During this period of time, the adherence to protocol was reinforced by telephone from health professionals whenever patients missed one day of their walking training detected by the central system. Patients were asked to continue their exercise program at home at a fixed walking speed, and return to the clinic at 1, 2, 3 and 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Home Exercise Training Program
Intervention Description
all the subjects were assessed by an incremental shuttle walking test (ISWT) (24) for estimation of exercise endurance. Baseline spirometry and body mass index (BMI) were recorded. The adherence and compliance of the home-based exercise training program was assessed by monitoring the frequency of performance and the duration of the endurance walking program recorded on the central system every week. Patients were asked to continue their exercise program at home at a fixed walking speed, and return to the clinic at 1, 2, 3 and 6 months.
Primary Outcome Measure Information:
Title
inflammatory cytokines
Description
IL-8
Time Frame
6 months
Title
C-reactive protein (CRP)
Description
CRP as systemic inflamatory status
Time Frame
6 months
Title
Incremental shuttle walk test (ISWT)
Description
Distence of shuttle walking test!
Time Frame
6 months
Title
spirometry
Description
FEV1 and FEV1/FVC.
Time Frame
6 months
Title
strength of limb muscles
Description
upper and lower limbs stregth
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25175787
Citation
Wang CH, Chou PC, Joa WC, Chen LF, Sheng TF, Ho SC, Lin HC, Huang CD, Chung FT, Chung KF, Kuo HP. Mobile-phone-based home exercise training program decreases systemic inflammation in COPD: a pilot study. BMC Pulm Med. 2014 Aug 30;14:142. doi: 10.1186/1471-2466-14-142.
Results Reference
derived

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Mobile-phone-based Home Exercise in Chronic Obstructive Pulmonary Disease

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