The aim of this exploratory study is to compare the effect of a lifestyle intervention program consisting of combined individual coaching and group sessions (CLI) with a lifestyle intervention program with individual coaching only (II).The program…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Blood and lymphatic system disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
body weight
Secondary outcome
Abdominal circumference (cm)
Number of spontaneous bleeds
Number of induced bleeds
Units coagulation factor concentrate used/year (IU)
Blood-pressurre (mm Hg)
Cholesterol spectrum including: total cholesterol, triglycerides,
HDL-cholesterol, LDL-cholesterol (mmol/l), all in non-fasting state
Glucose (mmol/l) in non-fasting state
Haemophilia activities of daily life (HAL): total score
Shortened Fat List: total score
Background summary
The prevalence of overweight and obesity is increasing in patients with
hemophilia and other bleeding disorders. In these patients physical activity is
often difficult due to arthropathy as a result of intra-articular bleeding in
the past, with decreased joint movement and pain and the fear of new bleeds.
This enhances weight gain, increases pressure on joints, leading to more bleeds
and more arthropathy. In the long term overweight and obesity increases risk of
cardiovascular diseases, with the concomitant need for anticoagulant therapy,
which further enhances the bleeding risk in these patients
Study objective
The aim of this exploratory study is to compare the effect of a lifestyle
intervention program consisting of combined individual coaching and group
sessions (CLI) with a lifestyle intervention program with individual coaching
only (II).The program is especially designed for patients with a bleeding
disorder
Study design
an exploratory randomised controlled unblinded intervention study
Intervention
15 patients will receive a combined lifestyle intervention program with
individual sessions and group sessions lasting for 2 years, the other 15
patients will receive individual sessions only and will be given the same
information as given in the group sessions, but on paper.
Study burden and risks
The main burden is in the group visits (16 times in2 years) the risk of
bleeding is very small:
- people with severe bleeding disorders use prophylactic coagulation factor
treatment
- people are supervised in their activities by the physiotherapist of the
hemophilia treatment center
- for physical activities personalized small goals are set by the patients
together with the specialized physiotherapist.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with hemophilia A, B, FVII deficiency, fibrinogen deficiency, von
Willebrand Disease or other bleeding disorder preferably requiring coagulation
products for prophylaxis or on demand in case of bleeding
- >= 18 years of age
- BMI >= 30 kg/m2
- Motivated to change their lifestyle
Exclusion criteria
- Health care insurance with ONVZ as this health insurance has no contract with
Profitt Lifestylecoaching.
- A contraindication or inability for physical activity as judged by the
treating hemophilia physician
- Participation in another research trial
- Unable to understand the written information
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 | NL82228.091.22 |