Long-term Activity Coaching in Patients With COPD

NCT ID: NCT04139200

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-22
• Study Completion Date: 2023-12-11

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Type 1 tele coaching group

Coaching with daily interaction with the coaching application, based on a adaptive physical activity goal

Group Type: EXPERIMENTAL

Type 1 physical activity tele coaching intervention

Intervention Type: BEHAVIORAL

A) Education about the importance of PA. During a one-to-one interview with the coach motivation, self-efficacy, barriers, favorite activities and strategies to become more active are discussed. B) Step counter providing direct feedback. C) A smartphone with a project-tailored application. The application provides automated coaching by displaying an activity goal (number of steps) and feedback on a daily basis. The feedback comes with a graphical presentation. Patients' targets are automatically revised weekly. The aim is to progressively increase the PA during the 12 weeks period and maintain afterwards. D) Telephone contacts triggered in the case of non-compliance with wearing the step counter, failure to transmit data, failure to progress or change in medication. Coaches are alerted by a note at the coaches' backend to take contact with the patient if needed.

Type 2 tele coaching group

Coaching with fixed physical activity goal and limited interaction with the smartphone application

Group Type: SHAM_COMPARATOR

Type 2 physical activity tele coaching intervention

Intervention Type: BEHAVIORAL

A) Education about the importance of PA. During a one-to-one interview with the investigator, patients will receive a personal goal (expressed in steps/day), based on their individual exercise capacity. B) A step counter providing direct feedback. C) A smartphone with a project-tailored application. The application receives the step data of the patient and asks on a weekly basis about the patient's change in medication. The application does provide a graph showing the steps the patient took and presents a general activity plan including their personal goal (which stays the same throughout the entire intervention period). D) Telephone contacts triggered in the case of change in medication. Coaches are alerted by a note at the coaches' backend to take contact with the patient if needed.

Interventions

Type 1 physical activity tele coaching intervention

A) Education about the importance of PA. During a one-to-one interview with the coach motivation, self-efficacy, barriers, favorite activities and strategies to become more active are discussed. B) Step counter providing direct feedback. C) A smartphone with a project-tailored application. The application provides automated coaching by displaying an activity goal (number of steps) and feedback on a daily basis. The feedback comes with a graphical presentation. Patients' targets are automatically revised weekly. The aim is to progressively increase the PA during the 12 weeks period and maintain afterwards. D) Telephone contacts triggered in the case of non-compliance with wearing the step counter, failure to transmit data, failure to progress or change in medication. Coaches are alerted by a note at the coaches' backend to take contact with the patient if needed.

Intervention Type: BEHAVIORAL

Type 2 physical activity tele coaching intervention

A) Education about the importance of PA. During a one-to-one interview with the investigator, patients will receive a personal goal (expressed in steps/day), based on their individual exercise capacity. B) A step counter providing direct feedback. C) A smartphone with a project-tailored application. The application receives the step data of the patient and asks on a weekly basis about the patient's change in medication. The application does provide a graph showing the steps the patient took and presents a general activity plan including their personal goal (which stays the same throughout the entire intervention period). D) Telephone contacts triggered in the case of change in medication. Coaches are alerted by a note at the coaches' backend to take contact with the patient if needed.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Ghent

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Thierry Troosters

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wim Janssens, Prof

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Heleen Demeyer, Dr

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Thierry Troosters, Prof

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Nikolaas De Maeyer, Dr

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Astrid Blondeel

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Eric Derom, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

UZ Gent

Fien Hermans

Role: PRINCIPAL_INVESTIGATOR

U Gent

Locations

UZ Gent

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S62902

Identifier Type: -

Identifier Source: org_study_id