iT-based Sports Therapy Application in Haemophilia

NCT04586101 | Completed

• 1 other identifier: 35318939
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Haemophilia is often associated with chronic pain, functional restrictions and negative consequences regarding the individual physical performance, especially on basic motoric skills, activities of daily life and quality of life. Caused by high benefits, physical activity is a fixed component and recommendation in the guidelines for the management of haemophilia. Several studies showed that goal-directed physical activity is feasible for patients with haemophilia (PwH) without any complications or bleeding episodes. Nevertheless, there are difficulties in the implementation of supervised sports therapy for PwH regarding local distributions and uncertainties concerning correct exercise execution on patients´ side and in the monitoring and adequate training regulation from long distances on the therapeutic side. Aim of this project is a patient-related and participative development and pre-evaluation of a mobile application to generate an online-guided, individualized home training for PwH, followed by pre-evaluation in terms of a twelve weeks interventional phase. The intention of this project is to show, that a mobile device is an appropriate way to increase physical activity of PwH. Due to the development of an innovative trainings application, adapted to the needs of PwH, a larger number of patients should be reached and supported later on in participating on supervised physical exercise to improve the individual physical performance and therefore the quality of life. Additionally, with an individualized exercise program also adapted to the specific interests, needs and physical conditions, PwH at any age can be addressed. Furthermore, in cooperation with the patient, the medical staff will get systematic information of patients´ exercise activities to generate optimal factor and overall treatment patterns. In addition, on the basis of the mobile device PwH will be able to comprehend their individual exercise performance and to get an overview of the individual trainings progress and improvements of physical performance with the purpose to enhance the processes of self-motivation. Detailed instructions and information of exercise execution, need of exercise and physical adaptions to be achieved, will minimize complications and support patients´ self-confident for participating on exercise.

Conditions

Haemophilia; Sports Physical Therapy

Keywords

haemophilia; sports therapy; trainings application; home training

Outcome Measures

Primary Outcomes (2)

• frequency of physical activity

  absolute number of completed physical activities

  12 weeks

• duration of physical activity

  mean duration of completed physical activities

  12 weeks

Secondary Outcomes (4)

• score of subjective physical performance measured by the HEP-Test-Q

  Day 1, 6 and 12 weeks

• score of subjective quality of life measured by the SF36 Health Survey

  Day 1, 6 and 12 weeks

• pain intensity in score points measured by the German Pain Questionnaire

  Day 1, 6 and 12 weeks

• health-related physical activity presented as metabolic equivalents of tasks

  Day 1, 6 and 12 weeks

Other Outcomes (3)

• bleeding events

  12 weeks

• factor substitution in international units

  12 weeks

• frequency of factor substitution

  12 weeks

Study Arms (2)

Training intervention

EXPERIMENTAL

Device: Trainings application

Control interverntion

NO INTERVENTION

Interventions

Trainings application DEVICE

Participants have to train with the developed trainings application over six weeks. For this, individual training plans are implemented in the application based on orthopedic joint status and training recommendations of a sports scientist.

Training intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients suffering from moderate to severe haemophilia A or B
• submitted written consent to participate in the study
• approved sports capability and internet access

You may not qualify if:

• patients suffering from other bleeding disorders
• patients without written consent
• patients under 18 years of age
• patients without sports capability
• patients without internet access

Sponsors & Collaborators

• Prof. Dr. Dr. Thomas Hilberg: lead
• Pfizer: collaborator

Study Sites (1)

Department of Sports Medicine, University of Wuppertal

Wuppertal, North Rhine-Westphalia, 42117, Germany

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair holder - chair of sports medicine

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: October 14, 2020
• Study Start: January 31, 2018
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)