Efficacy of Strength Training in Improving Elbow Range of... | NCT03842605

Studies
Efficacy of Strength Training in Improving Elbow Range of Motion and Function in Adults With Hemophilia

NCT03842605

Sponsor

Oregon Health and Science University

Status

Completed

Last Update Posted

Feb 15, 2019Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Hemophilia
Elbow Joint Contracture

Interventions

Strength training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Feb 2019Actual

Completion Date

Feb 13, 2019Actual

First Submitted Date

Apr 20, 2013

First Submission Date that Met QC Criteria

Feb 13, 2019

First Posted Date

Feb 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2019

Last Update Posted Date

Feb 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Oleson, Associate Professor, Oregon Health and Science UniversityPrincipal Investigator

Lead Sponsor

Oregon Health and Science UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Label	Type	Description	Intervention Names
Strength training	Experimental		Other: Strength training

Name	Type	Description	Arm Group Labels	Other Names
Strength training	Other		Strength training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Present inhibitor

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oregon Health and Science University		Portland	Oregon	97239-3098	United States

Condition Browse Module

MeSH Terms

ID	Term
D006467	Hemophilia A

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055070	Resistance Training

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided