NCT05608863

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilia

Interventions

Type	Name	Description
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.
OTHER	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.

Timeline

• Start date: 2022-11-02
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-11-08
• Last updated: 2025-08-11

Locations

1 site across 1 country: Netherlands