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

24 april 2018 uppdaterad av: Taipei Medical University

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.

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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Förväntat)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Taipei, Taiwan
        • Rekrytering
        • Taipei Medical Hospital-Shuang Ho Hospital,Ministry of Health and Welfare

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Experiment
Comprehensive 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.
Inget ingripande: Control
Guideline-based usual care

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from Baseline Lung function at 3 months, 6months
Tidsram: 3 months, 6months
Spirometry (FEVl % predicted )
3 months, 6months
Change from Baseline Exercise Tolerance at 3 months, 6months
Tidsram: 3 months, 6months
6 Minute walking test
3 months, 6months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from Baseline Health-related quality of life at 3 months, 6months
Tidsram: 3 months, 6months
St. George's Respiratory Questionnaire
3 months, 6months
Change from Baseline Fatigue at 3 months, 6months
Tidsram: 3 months, 6months
Brief Fatigue Inventory Short Form BFI-Taiwan Form
3 months, 6months
Change from Baseline Psychological distress at 3 months, 6months
Tidsram: 3 months, 6months
Hospital Anxiety and Depression Scale
3 months, 6months
Change from Baseline Symptom Distress at 3 months, 6months
Tidsram: 3 months, 6months
Taiwanese version of the M. D. Anderson Symptom Inventory
3 months, 6months
Change from Baseline Quality of Sleep at 3 months, 6months
Tidsram: 3 months, 6months
Taiwanese version of the Pittsburgh Sleep Quality Index
3 months, 6months
Readmission rate Survival
Tidsram: 1 year
pulmonologists blinded to allocation reviewed admission summaries and information to determine as COPD related readmission or mortality
1 year

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 mars 2018

Primärt slutförande (Förväntat)

31 juli 2020

Avslutad studie (Förväntat)

31 juli 2020

Studieregistreringsdatum

Först inskickad

2 januari 2018

Först inskickad som uppfyllde QC-kriterierna

6 januari 2018

Första postat (Faktisk)

12 januari 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 april 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 april 2018

Senast verifierad

1 november 2017

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • N201704032

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