NCT03842605

Brief Summary

This is a research study of adults with hemophilia that have limitations in elbow joint motion that is the result of bleeding into the joint. People with hemophilia who have bleeding into their elbow joint may have limitations in elbow joint movement and pain in the joint. This research is being done to determine the effect a strength training program has on the amount of movement people with hemophilia and elbow joint disease have.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2013

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

6.3 years

First QC Date

April 20, 2013

Last Update Submit

February 13, 2019

Conditions

HemophiliaElbow Joint Contracture

Outcome Measures

Primary Outcomes (1)

  • Elbow range of motion

    measurement of change of range of motion over time frame

    measurements to be taken at 4 and 8 weeks after entering study

Study Arms (1)

Strength training

EXPERIMENTAL
Other: Strength training

Interventions

Strength trainingOTHER
Strength training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of the Oregon health and Science University Hemophilia treatment Center
  • greater or equal to 18 years old
  • Loss of elbow range of motion that is greater than or equal to 5 degrees

You may not qualify if:

  • Present inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 20, 2013

First Posted

February 15, 2019

Study Start

October 1, 2012

Primary Completion

February 1, 2019

Study Completion

February 13, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

US(1)