The Effect of 16 Weeks of Hip Adduction and Abduction Res... | NCT01228877

Studies
The Effect of 16 Weeks of Hip Adduction and Abduction Resistance Exercise

NCT01228877

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Oct 27, 2017Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Osteoporosis
Osteopenia
Sarcopenia

Interventions

exercise

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

Oct 2017

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

Dec 2010

Primary Completion Date

Jun 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Oct 8, 2010

First Submission Date that Met QC Criteria

Oct 26, 2010

First Posted Date

Oct 27, 2010Estimated

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

Oct 25, 2017

Last Update Posted Date

Oct 27, 2017Actual

Name	Class
National Space Biomedical Research Institute	OTHER

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

Performing adduction and abduction resistance exercise will increase hip bone density and strength to a greater extent than doing squat and deadlift exercise.

Aim #1: To determine if doing hip adduction and abduction resistance exercise training for 16 weeks improves spine bone mineral density and hip bone mineral density and strength as determined by finite element modeling.

Aim #2: To compare the effects of hip adduction and abduction exercise to squat and deadlift exercise with respect to potential changes in hip bone mineral density and strength.

Aim #3: To determine if the addition of adduction and abduction exercise to squat and deadlift exercise promotes an "additive" effect with respect to changes in spine bone mineral density and hip bone mineral density and bone strength.

Detailed Description

The investigators will carry out a 16-week exercise training study (n=24) consisting of 3 groups (n=8 per group) of healthy, non-resistance trained adult men and women (age 25-55 years). Our aim is to determine if hip adduction and abduction resistance exercise is more effective than squat and deadlift exercise with respect to changes in the whole bone strength and density of the proximal femur and spine.

Group A will do only hip adduction and abduction exercises. Group B will do only squat and deadlift exercise Group C will do a combination of hip adduction and abduction and squat and deadlift exercise

Subjects will be imaged with quantitative computed tomography (QCT) of the proximal femur and spine, pre-training and post-training, to determine changes in spinal bone density and proximal femoral bone density and strength.

Serum assays of bone formation (osteocalcin) and bone resorption (serum CTX type I) will be performed four times during the study at 4 week intervals.

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

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise	Experimental	Adduction, Abduction and Squat exercise three times a week for 16 weeks	Other: exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise	Other	Adduction, Abduction and Squat exercise three times a week for 16 weeks	Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduce risk of hip fracture	The investigators have prioritized the last year of NSBRI funding to test one the capabilities of our device, standing hip adduction/abduction exercise, to strengthen the proximal femoral bone. We believe that if we are able to detect increases in bone density and strength (assessed using quantitative computed tomography of the hip pre- and post-training) in healthy volunteers, this will be solid preliminary evidence to support modification of exercise protocols currently being used to reduce the rate of bone loss on the International Space Station.	16 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy men and women
Age of 25 to 55 years old

Exclusion Criteria:

Hypertension (High blood pressure)
Diabetes or metabolic syndrome
Hyperlipidemia (High cholesterol)
Cardiovascular Disease
Asthma or other pulmonary disease (i.e. COPD)
not pregnant
have no joint or mobility limitations
do not exercise on a regular basis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Lang, PhD	UCSF-Department of Radiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSF-Department of radiology-China Basin		San Francisco	California	94107	United States

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis
D001851	Bone Diseases, Metabolic
D055948	Sarcopenia

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided