Lifestyle Behaviours of Women Newly Diagnosed With Heart Failure
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNewcastle University
About this trial
Heart Failure occurs when the heart's ability to pump blood is reduced. Heart failure can lead to symptoms of breathlessness, fatigue and ankle swelling, and result in health complications including damage to other organs (e.g. kidneys), reduced function and quality of life. Although the symptoms of heart failure are similar for men and women, there are sex differences. Lifestyle behaviours such as physical activity are important modifiable risk factor for heart failure. Women continue to be underrepresented in heart failure studies and treatment guidelines are male-derived due to these disparities in recruitment. The purpose of the present study is to evaluate the physical activity levels, sedentary behaviour, sleep and quality of life and understand the barriers and facilitators to these lifestyle behaviours in women newly diagnosed with heart failure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult women with a new diagnosis of heart failure after referral to the RVI Heart Failure Diagnostic Clinic;
Able to walk and perform activities of daily living independently;
New York Heart Association functional class II-IV;
Willingness to undertake physical activity monitoring;
Disqualifiers
Male;
Already diagnosed with heart failure;
Presented with severe symptoms requiring urgent assessment and stabilisation (e.g. breathless at rest, hypotension, confusion);
Major co-morbidity or other alternative diagnoses of no obvious acute and self-limiting cause (e.g. malignancy, severe respiratory disease, mental health problem);
Trial population
Women newly diagnosed with heart failure
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Actigraph GT3X+BT
Device7 day monitoring of physical activity, sedentary behaviour and sleep using the Actigraph GT3X+BT
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Women newly diagnosed with heart failure1 intervention
Trial outcomes
Primary outcomes
1
Number of steps per day during a 7-day monitoring period
7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis
Time frame
7-day at the time of diagnosis2
Intensity of physical activity (light physical activity, measured in minutes per day) during a 7-day monitoring period
7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis
Time frame
7-day at the time of diagnosis3
Intensity of physical activity (moderate physical activity, measured in minutes per day) during a 7-day monitoring period
7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis
Time frame
7-day at the time of diagnosis4
Intensity of physical activity (vigorous physical activity, measured in minutes per day) during a 7-day monitoring period
7-day objective assessment using Actigraph GT3X+BT accelerometry at the time of diagnosis
Time frame
7-day at the time of diagnosisSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov