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

Not Applicable

Active, not recruiting

• Conditions: Hemophilia
• Interventions: Other: Lifestyle - group sessions; Other: Lifestyle - individual coaching

• Registration Number: NCT05608863
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-10-26
• Study Start: 2022-11-02
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-08
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined intervention	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
individual intervention	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

Primary Outcome Measures

Name	Time	Method
kg	36 months	The main study parameter is body weight in kg.

Secondary Outcome Measures

Name	Time	Method
Haemophilia activities of daily life (HAL)	36 months	Total score
Abdominal circumference (cm)	36 months
Number of spontaneous bleeds	36 months
Units coagulation factor concentrate used/year (IU)	36 months
Number of induced bleeds	36 months
Shortened Fat List	36 months	Total score
Blood-pressurre (mm Hg)	36 months
Cholesterol spectrum	36 months	including: total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol (mmol/l), all in non-fasting state
Glucose (mmol/l)	36 months	in non-fasting state

Trial Locations

Locations (1)

RadboudUMC; 🇳🇱 Nijmegen, Gelderland, Netherlands