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Long-term Activity Coaching in Patients With COPD

2019-10-30 14:03:47 | BioPortfolio

Summary

Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of mortality and morbidity around the world. Studies revealed that patients with COPD are less active than age-matched healthy controls and activity level decreases with disease severity. Higher levels of physical activity is related to important health-related outcomes, such as lower mortality rate and hospital admissions. Additionally, increasing physical activity is related with substantial health benefits. Patients with COPD have a higher risk of developing insulin resistance, hypertension, dyslipidemia, osteopenia, leading to chronic diseases such as coronary heart disease, type 2 diabetes and osteoporosis, which have been related to physical inactivity in the healthy population. Moreover, physical inactivity has been related to the occurrence of comorbidities in patients with COPD. Therefore, improving physical activity levels is a recommended treatment in the disease management in all patients with COPD and is implemented in the recent GOLD guidelines for all patients with COPD, regardless of the disease severity.

Our research group investigated the effect of a 3-month semi-automatic tele-coaching intervention on physical activity levels in patients with COPD. The tele coaching intervention led to a significant improvement on physical activity in the intervention group. Although this trial showed positive results on physical activity, further research is needed, mainly to investigate the long-term (12 months) effectiveness of such interventions and the added value of a smartphone application on top of a simple step counter providing feedback. Additionally, since physical activity is related to the development of comorbidities, we aim to explore the influence of improving physical activity levels on the occurrence of cardiovascular, metabolic and musculoskeletal comorbidities. Finally, this study will explore baseline characteristics (such as social support, self-efficacy, dynamic hyperinflation, etc.) that can predict success in this intervention.

Description

The aims of the present study are:

1. primary objective: To investigate the changes in physical activity after a 12-month tele coaching intervention (including individualized goal setting, feedback, motivational contacts with coach and a step counter providing direct feedback), compared to a sham group receiving a light coaching intervention (feedback from step counter and static goal setting, without additional motivation or contact with the coach).

2. secondary objectives: A. Investigate the effect of a 12-month tele coaching intervention on exercise capacity, muscle force, quality of life, physical activity from a patient's perspective, dyspnea-related fear and comorbidities.

B. Confirming previous findings on short-term effects (or lack of effect) of the tele coaching intervention on physical activity, exercise capacity and quality of life, assessed at 6 months.

C. Identifying possible baseline characteristics that are determinants of the change in physical activity after the 12-month tele coaching intervention.

D. Investigating the association between the physical activity pattern and the onset of an exacerbation.

E. To explore the relation between dynamic hyperinflation as measured during the six-minutes walk test, physical activity measured at baseline and change in physical activity as result of the intervention.

Therefore, the study will include stable patients with COPD (post bronchodilator FEV1/FVC < 0.70) with no moderate or severe exacerbations in the past month, across all disease severities.

The study will consists of a total 4 visits clinical visits:

- Visit 1 screening visit

- Visit 2: randomization visit, scheduled 1-2 weeks after visit 1

- Visit 3: short term follow-up visit, scheduled 6 months after visit 2

- Visit 4: long-term follow-up visit, scheduled 12 months after visit 2

All patients included in the study will be randomized in either the intervention group or sham group:

- A multicomponent tele coaching intervention that consists of 1) education about the importance of physical activity and a one-to-one interview with the coach discussing the motivation and barriers to be active, 2) a step counter providing direct feedback, 3) application installed on a smartphone providing an adaptive goal and daily and weekly feedback and 4) contact with the coach if the patient is not compliant with the intervention, not increasing physical activity or when the patient reports a change in medication. The patient is asked to have a daily interaction with the smartphone application.

- A sham intervention that consist of 1) education about the importance of physical activity and a personal (fixed) goal expressed in terms of steps. The patient is asked to try to reach this goal, 2) a step counter providing direct feedback, 3) application installed on a smartphone only displaying a graph with the activity of the present week and the personal (fixed) goal, 4) contact with the coach if the patient reports a change in medication. The patient is asked to have at least a weekly interaction with the application.

Study Design

Conditions

COPD

Intervention

Type 1 physical activity tele coaching intervention, Type 2 physical activity tele coaching intervention

Status

Not yet recruiting

Source

KU Leuven

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-30T14:03:47-0400

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