Preventing Falls and Disability in Older Adults After Hip... | NCT00795028

Studies
Preventing Falls and Disability in Older Adults After Hip Fracture

NCT00795028

Sponsor

University of British Columbia

Status

Withdrawn

Last Update Posted

Apr 28, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hip Fracture

Interventions

Standard Care for people after hip fracture
Standard Care + exercise intervention

Countries

Not provided

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013Actual

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Nov 20, 2008

First Submission Date that Met QC Criteria

Nov 20, 2008

First Posted Date

Nov 21, 2008Estimated

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

Apr 26, 2023

Last Update Posted Date

Apr 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maureen C. Ashe, Principal Investigator, University of British ColumbiaPrincipal Investigator

Lead Sponsor

University of British ColumbiaOTHER

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

Patients who have suffered a first hip fracture have a higher risk of falling and sustaining another hip fracture compared with age-matched adults who did not fracture. Although exercise is key to reversing this pattern, there have been very few trials that aimed to improve muscle strength and balance as well as enhance bone health following hip fracture. Therefore, we propose to conduct an RCT that delivers either 12 months of standard care or standard care plus graduated exercise program for older women who have sustained a recent hip fracture.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Standard Care for people after a hip fracture	Other: Standard Care for people after hip fracture
2	Experimental	Standard Care + exercise intervention	Other: Standard Care + exercise intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard Care for people after hip fracture	Other		1
Standard Care + exercise intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fall rate, measured by self-reported daily fall diaries, will be collected monthly at the exercise classes and followed up by an independent investigator		Monthly

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older community dwelling women who have sustained a first hip fracture

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

105 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
M C Ashe, PhD	University of British Columbia	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided