He-move-philia, Lifestyle Intervention for Patients With Hemophilia

Hemophilia Clinical Trial

Official title:

He-move-philia, a Combined Lifestyle Intervention Program for Patients With Hemophilia and Other Bleeding Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05608863
• Other study ID #: HEMSTOL75
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objectives are reduction of body weight, BMI and abdominal circumference. Secondary objectives are reduction of bleeds and units coagulation factor concentrate used, blood-pressure, cholesterol spectrum, glucose and improvement of physical activity and dietary habits. one group of patients will receive a combined lifestyle intervention program with individual sessions and group sessions lasting for 2 years, the other group of patients will receive individual sessions only and will be given the same information as given in the group sessions, but on paper.

Description:

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. 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. The investigators hypothesize that body weight, BMI, abdominal circumference, bleeds and units coagulation factor concentrate, as these are dosed on body weight, will decrease in both groups, but more in the CLI with group sessions.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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
• Being able to speak, read and understand the Dutch language Exclusion criteria
• Health care insurance with CZ or ONVZ as these health insurances have 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
• Unable to sign the informed consent
• Unwilling to randomize to the combined or individual intervention group

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

Intervention

Other:
• Lifestyle - group sessions
The Combined Lifestyle Intervention Program consists of a total of 7 individual coaching sessions and 16 group sessions in a 2 year program. The individual coaching sessions will be done in a virtual setting.
• Lifestyle - individual coaching
The Individual Intervention consists of a total of 7 individual coaching sessions in a 2 year program and additional written information. These will be done in a virtual setting.

Locations

Country	Name	City	State
Netherlands	RadboudUMC	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BREQ-3 questionnaire		Baseline (week 0)
Other	Regulation of Eating Behaviour Scale (REBS)		Baseline (week 0)
Other	Patient satisfaction with the program will be measured using some questions		36 months
Primary	kg	The main study parameter is body weight in kg.	36 months
Secondary	Abdominal circumference (cm)		36 months
Secondary	Number of spontaneous bleeds		36 months
Secondary	Number of induced bleeds		36 months
Secondary	Units coagulation factor concentrate used/year (IU)		36 months
Secondary	Blood-pressurre (mm Hg)		36 months
Secondary	Cholesterol spectrum	including: total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol (mmol/l), all in non-fasting state	36 months
Secondary	Glucose (mmol/l)	in non-fasting state	36 months
Secondary	Haemophilia activities of daily life (HAL)	Total score	36 months
Secondary	Shortened Fat List	Total score	36 months