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What is the Feasibility of the ISTEP Exercise Test in Boys With Haemophilia

NCT04076306 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-09-06

No results posted yet for this study

Summary

This study will be used to assess the feasibility and sensitivity of using the iSTEP, to assess exercise capacity in boys with haemophilia.

The feasibility criteria to be explored includes:

1. Recruitment to target number or better
2. The test procedure is completed within an allocated time (1-2 hours) and by 90% of participants without serious adverse events
3. 90% of participants achieve a sufficient exercise response (85% maximum heart rate (HRmax))
4. Calculation of estimates of minimum clinically important differences and variability for sample size calculations and responsiveness to severity of haemophilia and orthopaedic status The iSTEP exercise test will be compared to a more commonly used exercise test the modified shuttle walk test (10m- MSWT). Muscle strength (using myometry) will also be tested and compared to exercise performance for any relationships. Physical activity levels will also be assessed to obtain some baseline measurements of physical activity levels in this patient population, which are currently not very well known. The overarching aim of this current study is also to establish a robust and sensitive exercise test and to gain an understanding of the effects of physical activity levels and muscle strength on exercise capacity in this population.

Conditions

Interventions

OTHER

iSTEP exercise testing

iSTEP 10 minute step test, up and down on a commercial standard 3-height adjustable step Undertaking the 10m-MSWT 20-30 minutes Procedure takes place on testing track at Great Ormond Street Hospital; a 5 minute walk from the Haemophilia Centre. One of the research team accompanies the family with child to the track and will accompany them back to the Centre once testing is finished. Muscle Myometry 10 minutes, carried out by one of the research team at the end of the physiotherapy clinical assessment in the Haemophilia Centre. Wearing of accelerometer (activity/ step counter)7 days Device will be set up and provided at the end of the testing on the day of attendance at clinic. They will be instructed to wear this throughout the week at home when they are awake (at least 8 hours). Haemophilia Joint Health Score (HJHS) - a standardised outcome measure of joint health in people with Haemophilia, undertaken by the Clinical Specialist Physiotherapists in Haemophilia.

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Nicola Thorpe · Great Ormond Street Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-25
Primary Completion
2018-11-02
Completion
2018-11-02

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04076306 on ClinicalTrials.gov