The purpose of this study is to test the impact of a physical activity promotion program which is a personalized, semi-automated, coaching program utilizing an smartphone on which an app is installed and coaching by the investigator. The automated…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objectives are:
• To assess the impact of a physical activity promotion program on physical
activity in patients with COPD in addition to usual care. This will be measured
by the PROactive monitors (ActiGraph® and DynaPort®), as the change in average
daily number of steps at baseline (during the week prior to visit 101) and at
the end of the 3-month epoch (during the week prior to Visit 102).
• To assess construct validity of the daily version of PROactive instrument and
its responsiveness to a telecoaching program in addition to usual care in COPD
patients.
Secondary outcome
The secondary objectives are to assess change from baseline to 3 months between
the intervention group and the control group in:
1-Time spent in at least moderate physical activity
2- Proportion of patients showing an increase of physical activity by >20%
3- Exercise capacity (6-minute walking test (6MWT); Incremental shuttle walk
test (ISWT) in a subset of mild patients)
4- Muscle strength (as measured by quadriceps maximal volitional contraction)
5- COPD symptoms and health-related quality of life (as measured by the CAT,
CCQ, HADS, mMRC and SGRQ-C)
6- Change from baseline to 3 months between the intervention group and the
control group in average daily number of steps
7- Satisfaction with the coaching system
Background summary
In the next decade Chronic Obstructive Pulmonary Disease (COPD) will affect an
increasing number of European citizens. Physical inactivity and symptoms during
physical activity are a hallmark of COPD and inactivity itself contributes to
the disease progression. The inability to participate in daily activities is an
important consequence of COPD experienced by patients on a daily basis.
Improvement of the ability to participate in physical activity is an important
patient centred target in the management of COPD. Despite its importance,
currently no Patient Reported Outcome (PRO) captures physical activity in daily
life in a way that maximally reflects the experience of COPD patients.
Study objective
The purpose of this study is to test the impact of a physical activity
promotion program which is a personalized, semi-automated, coaching program
utilizing an smartphone on which an app is installed and coaching by the
investigator. The automated telehealth system comprises of a smartphone and a
CE marked step counter (Fitbug®). The coaching by investigator is performed
during study visits and is aimed to enhance physical activity in patients
across a spectrum of COPD severity, in addition to usual care. The study will
also validate the PROactive instrument (a combination of a patient reported
outcome on a questionnaire and physical activity monitoring tool) developed in
Work Package 4 (WP4) of the PROactive project. Limitation in physical activity
is an important endpoint reported by COPD patients, which also contributes to
the progression of the disease. Despite its importance, there are currently no
available measures to capture physical activity in daily life that reflect
relevant dimensions of patients* experiences of such limitations.
Study design
This is a 3 month, randomized (1:1 ratio), parallel-group, multicenter trial.
Patients in both groups (control and intervention) will receive information and
guidance on the benefits associated with increased physical activity in COPD
patients and their health status. Patients in both groups will use two
PROactive monitors (ActiGraph® and DynaPort®) and a PDA to complete the
PROactive questionnaire. In addition to above, the patients in the intervention
group will receive daily coaching by an automated telehealth system, via an app
on a smartphone, and coaching by the investigator during study visits.
Intervention
not applicable
Study burden and risks
Central aim of this study is the evaluation of a physical activity promotion
program and validation of a questionnaire with which the patient's experience
of their physical activity and their limitations in this can be measured. In
order to properly reflect the patients perspective it is of vital importance to
include a heterogeneous group of COPD patients in this process.
Participation will take patients' time. They will attend three visits to the
hospital and they will partake in 2 periods of seven days during which they are
asked to complete the PROactive tool (wear a pedometer and complete a short
questionnaire).
There are no particular risks associated with this study. As a result of the
various clinical assessments, including questionnaires, the patient may
experience some tiredness or fatigue, or after the exercise tests muscle
soreness. This will quickly pass as usual. Most of the assessments are part of
the standard COPD treatment programme .
The results of this study will contribute to future improvement of the
treatment of COPD patients.
Raapopseweg 1
Arnhem 6824 DP
NL
Raapopseweg 1
Arnhem 6824 DP
NL
Listed location countries
Age
Inclusion criteria
•Written informed consent must be obtained before any assessment is performed.
•Male and female patients >= 40 years of age
•Diagnosis of COPD (GOLD criteria: post bronchodilator FEV1/FVC< 70%)
•Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year)
•Patient should have at least 4 days of physical activity data recorded via PROactive monitors during 7 days prior to visit 101.
Exclusion criteria
•Orthopedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator. Specifically if the patients* condition/ co-morbidities are such that physical activity cannot be increased.
•Respiratory diseases other than COPD (e.g. asthma)
•Cognitive reading impairment and/or difficulties to manage electronic devices precluding interaction with the healthbase and PDA, as judged by the investigator
•Participating in or scheduled to start a rehabilitation program during the study. If the patient wishes to participate in pulmonary rehabilitation for any reason the patient can be enrolled in the study only at the end of rehabilitation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45626.042.13 |