Clinical trial NCT04139200: Long-term Activity Coaching in Patients With COPD
Official title: The Long-term Effects of a Tele Coaching Intervention in Patients With COPD: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Physical activity
Tele coaching
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2019-10-25
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization
Primary purpose: TREATMENT

Brief 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.

The 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, the investigators 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.

Detailed 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 pattern in vital signs (including physical activity, resting heart rate, heart rate variability, heart rate recovery, oxygen saturation, respiratory rate) as measured by a wearable 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.

F. Investigate the effect of an acute exacerbation on functional performance (only in Ghent).

G. Investigate the association between a change in physical activity and autonomic function (only in Ghent).

H. Validity and reliability of wearable devices to measure autonomic function, respiratory rate and oxygen saturation (only in Ghent).

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.

For patients in UZ Leuven and UZ Ghent, the study will consists of 4 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

Only for patients in UZ Ghent: to investigate the effect of an acute COPD exacerbation on functional performance, an additional visit will take place when the patient experiences an exacerbation after the first 6 months of the study. This visit will take place as soon as possible and maximally 14 days after onset of the symptoms.

If the patient does not experience an exacerbation during the first year of the study, the patient will be followed-up until occurrence of the first exacerbation or up to 30 months (whichever occurs first) with intermediate visits at 18 months and 24 months.

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.
* Only in UZ Ghent: in case of extended follow-up after 12 months, patients will receive the multicompenent tele coaching intervention after 12 months of inclusion in the study.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with COPD (GOLD criteria post bronchodilator FEV1/FVC \< 0.70)
2. Patients under medical follow-up of a respiratory physician or general practitioner with no moderate (ambulatory treated) and/or severe (requiring a hospital admission) exacerbation in the past month
3. Older than 40 years old
4. Smoking history with more than 10 pack years

Exclusion Criteria:

1. The presence of orthopedic or other problems not allowing an increase in physical activity levels
2. Unable to learn to work with a new electronic device (e.g. smartphone), as judged by the investigator
3. Underwent lung transplantation or active on the lung transplantation list
4. Involved in or planned to start with a structured multidisciplinary rehabilitation program

Primary outcomes:
measure: Daily number of steps at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Daily number of steps at 6 months
timeFrame: 6 months
measure: Minutes per day spent in at least moderate intense activities
timeFrame: 6 months and 12 months
measure: Mean walking time per day
timeFrame: 6 months and 12 months
measure: Mean sedentary time per day
timeFrame: 6 months and 12 months
measure: Exercise capacity
timeFrame: 6 months and 12 months
measure: Quadriceps force
timeFrame: 6 months and 12 months
measure: Health status
timeFrame: 6 and 12 months
measure: Health related quality of life: CRDQ-SAS
timeFrame: 6 months and 12 months
measure: Physical activity from a patients' perspective
timeFrame: 6 months and 12 months
measure: Dyspnea-related fear
timeFrame: 6 months and 12 months
measure: Symptoms of anxiety and depression
timeFrame: 12 months
measure: Functional performance
timeFrame: Only in Ghent - as soon as possible and max 14 days after the occurrence of an COPD exacerbation
measure: Autonomic function
timeFrame: Only in Ghent - 6 months and 12 months; additionally at 18 months and 24 months in case of extended design
measure: Autonomic symptoms
timeFrame: Only in Ghent - 6 months and 12 months; additionally at 18 months and 24 months in case of extended design
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: KU Leuven
name: Wim Janssens, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Heleen Demeyer, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Thierry Troosters, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Leuven
name: Nikolaas De Maeyer, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Astrid Blondeel
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Gent
name: Eric Derom, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: U Gent
name: Fien Hermans
role: PRINCIPAL_INVESTIGATOR
References: