The primary objective of this explorative study is to investigate the effect of 3-month preparation period of regular walking exercise prior to the Nijmegen 4-Day marches on objectively measured AF burden (primary parameter), self-reported AF burden…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is AF burden, as measured by time spent in AF.
Secondary outcome
Secondary study parameters are quality of life and blood biomarkers.
Background summary
Atrial fibrillation (AF) is the most common persistent cardiac arrhythmia.
Exercise based cardiac rehabilitation has increasingly shown its potential
benefits for AF. Walking as exercise intervention for AF patients has not been
studied much, while being low cost and accessible and providing low-to-moderate
intensity endurance exercise.
Study objective
The primary objective of this explorative study is to investigate the effect of
3-month preparation period of regular walking exercise prior to the Nijmegen
4-Day marches on objectively measured AF burden (primary parameter),
self-reported AF burden and various blood biomarkers in AF patients and
controls. The secondary objective is to investigate the effect of 4 consecutive
bouts of prolonged walking exercise (i.e., 4-day Marches) on objectively
measured AF burden (primary parameter), quality of life and various blood
biomarkers in paroxysmal, permanent, and post-ablation AF patients and
controls.
Study design
Longitudinal observational study.
Study burden and risks
For Objective 1, participants will visit the research centre twice in
preparation of the 4-day Marches. Three months prior to (i.e., baseline) and
12-36 hours prior to (i.e., post-training) the 4-day Marches, participants
report to our laboratory and we will collect data on personal characteristics,
ECG measurements, blood pressure, body composition, blood samples, walking
capacity, and questionnaires. In addition, during 3 assessments prior to the
4-Day Marches, participants will wear an ePatch (2-lead ECG measurements) to
objectively measure AF burden and the ActivPAL to objectively evaluate physical
activity levels for 7 consecutive days. Participants will fill in a training /
daily physical activity diary throughout the preparation period prior to the
4-day Marches (May-Jul). For Objective 2, participants will wear an ePatch
(2-lead ECG measurements) to continuously and objectively measure AF burden
during the 4-Day Marches and its recovery (up to 72 hrs following completion).
In addition, after each walking day, participants report to our laboratory to
evaluate blood pressure, weight, blood samples, urine analysis and
questionnaires. PPG measurements will be performed by the participant during 3
different timepoints, on 7 consecutive days, 3 times per day.
Only withdrawal of venous blood proposes a limited risk for the participants,
since this is associated with a 5% risk of developing a haemorrhage. However,
this will disappear within 2 weeks and is not associated with any (functional)
limitations. We have graded the risk profile of this study as *negligible
risk*.
Reinier Postlaan 4
Nijmegen 6525GC
NL
Reinier Postlaan 4
Nijmegen 6525GC
NL
Listed location countries
Age
Inclusion criteria
- Age >18 years
- Able to understand and perform the study procedures
- Diagnosis of paroxysmal atrial fibrillation
- If the patient underwent an ablation procedure, the patient is eligible to
participate if the atrial fibrillation has returned post-ablation
Exclusion criteria
- Age < 18 years
- No diagnosis of AF
- Diagnosis of permanent or persistent AF
- Patients with prior cerebro-/cardiovascular event (e.g., myocardial
infarction) during the last 6 months
- Existence of a different disease impairing quality of life stronger than the
underlying heart disease
- AF following intoxication, medication or acute infection
- Disability to understand the study protocol
- Planned holidays during the measurement weeks or during the ePatch wear
weeks.
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 | NL88341.091.24 |