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Effects of a Comprehensive Health Coaching Program in Advanced Chronic Obstructive Pulmonary Disease.

Effects of a Comprehensive Health Coaching Program on Lung Function, Exercise Tolerance, Symptom Distress, Quality of Life, Readmission, and Survival in Advanced Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03398772
Enrollment
50
Registered
2018-01-12
Start date
2018-03-01
Completion date
2020-07-31
Last updated
2018-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease End Stage, Chronic Obstructive Pulmonary Disease Severe

Brief summary

Chronic obstructive pulmonary disease due to incurable and prevalence has increased steadily, chronic respiratory disease is considered hazardous to health and quality of life of the disease. GOLD treatment guidelines (global initiative for chronic obstructive lung disease guideline) pointed out the pulmonary rehabilitation is one of the non-drug treatment in patients with severe COPD, shown to improve exercise capacity and reduce the short of breathing, improve the quality of life and reduce the anxiety associated and depression and improved survival advantages. Meanwhile, a few studies have examined effect the exercise training in severe COPD patients' symptom distress and quality of life, so as to make severe COPD patients to improve the effectiveness of the campaign to ongoing regular pulmonary rehabilitation movement, is considered an important issue. It has been proposed that physical activity enhancement or exercise training can be effective in improving symptoms and quality of life in these patients. However, it has not been examined systematically. Therefore, the main purposes of this study are: 1.Prevalence of symptom distress; 2.The physical preferences; 3.The relationship between quality of life and physical activity; 4.Effects of Comprehensive Health coaching exercise training on improving fatigue, sleep disturbances, quality of life, readmission, and survival. In the first year of this study, a descriptive-correlational design will be used and in the second and third years of study, the experimental design and prospective longitudinal study will be undertaken. Instruments include motion sensors, physical activity scale, Physical Activity Preferences, Pittsburgh Sleep Quality of Life Index. Statistical analyses include descriptive statistics, t-test, one-way ANOVA, latent growth modeling, Logistic models, GEE, and survival analysis. Results from this study will provide important implications for improving symptom management and quality of life for sever chronic obstructive pulmonary disease patients.

Interventions

BEHAVIORALComprehensive Health Coaching Program

Comprehensive Health Coaching Program: included physical activity and motivational interviewing techniques, participants were encouraged to set goals with decision-making, self-management and self-monitor their progress, and received support from researcher.

Sponsors

Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* age ≥40 years and ≦80 years * patients with advanced COPD are defined according to the diagnostic criteria for severe (GOLD 3) and very severe (GOLD 4) * pulmonologist assess need pulmonary rehabilitation, but not accept any rehabilitation exercise program. * pulmonologist assessment the patients with a stable state. * awareness, has the ability to read, write, and communication. * willing to communicate by phone, and can operate smart phones.

Exclusion criteria

* COPD AE requiring corticosteroids, antibiotics, emergency room visit or hospitalization within the past 3 month. * diagnosed mentally or cognitive disorder, such as dementia or unable to cooperate. * severe hip, knee disease, can not perform exercise, or with neuromuscular dysfunction, such as limb hemiplegia, no independent walking function or other deterioration due to bone and joint disease. * combined with severe heart disease, such as AMI, severe arrhythmia or heart failure. * current regular practice of physical activity

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Exercise Tolerance at 3 months, 6months3 months, 6months6 Minute walking test
Change from Baseline Lung function at 3 months, 6months3 months, 6monthsSpirometry (FEVl % predicted )

Secondary

MeasureTime frameDescription
Change from Baseline Psychological distress at 3 months, 6months3 months, 6monthsHospital Anxiety and Depression Scale
Change from Baseline Symptom Distress at 3 months, 6months3 months, 6monthsTaiwanese version of the M. D. Anderson Symptom Inventory
Change from Baseline Health-related quality of life at 3 months, 6months3 months, 6monthsSt. George's Respiratory Questionnaire
Readmission rate Survival1 yearpulmonologists blinded to allocation reviewed admission summaries and information to determine as COPD related readmission or mortality
Change from Baseline Quality of Sleep at 3 months, 6months3 months, 6monthsTaiwanese version of the Pittsburgh Sleep Quality Index
Change from Baseline Fatigue at 3 months, 6months3 months, 6monthsBrief Fatigue Inventory Short Form BFI-Taiwan Form

Countries

Taiwan

Contacts

Primary ContactHuang Ya-Hsuan, PhD
d432104001@tmu.edu.tw0979306004

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026