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Provincial Health Services Authority :Osteofit Roll-Out: An Inclusive Provincial Bone Health Strategy
This study is not yet open for participant recruitment.
Verified by University of British Columbia, September 2008
First Received: January 31, 2007   Last Updated: September 24, 2008   History of Changes
Sponsors and Collaborators: University of British Columbia
Provincial Health Services Authority
Information provided by: University of British Columbia
ClinicalTrials.gov Identifier: NCT00431002
  Purpose

The main purpose of this study is to investigate the effect of two different group-based exercise programs on fall risk (muscular strength and balance) and bone strength in older women aged over 65-75 years who have low bone mass. We are also trying to determine if once a week exercise is as effective on health outcomes as twice a week. We hypothesize that twice a week exercise will be more effective than once a week or sham exercise.


Condition Intervention
Osteoporosis
Behavioral: Resistance training

MedlinePlus related topics: Exercise and Physical Fitness Osteoporosis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Exercise and Osteoporosis: A 12-Month Randomized Controlled Trial of Osteofit Strength and Balance Exercises Compared With a Stretch and Relaxation Program on Bone Strength and Falls Risk

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Physiologic Profile Assessment (Fall Risk) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone strength using peripheral quantitative computed tomography (pQCT) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: March 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Resistance training
    See Detailed Description.
Detailed Description:

This 12 month study will take place in a community center in Vancouver, BC and we plan to enroll 165 women. Women will be randomly assigned to one of three programs (55 women/group): the Osteofit Training Program once a week, Osteofit Training Program twice a week or the Stretch and Relax Program.

Osteofit Training (Either 1 or 2x/week). Each session of this program will be will 50 minutes and involves a series of stretching and strengthening exercises all of the major muscle groups of the upper and lower body. Stretch and Relax. Each session of this program will be will 50 minutes and involves a series of stretching exercises and relaxation techniques. Relaxation techniques will include visualization, breathing exercises, and contract-relax techniques.

At the beginning, middle and end of the study (baseline, 6 and 12 months), we will collect outcomes on fall risk, bone health, general fitness and quality of life.

  Eligibility

Ages Eligible for Study:   65 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sedentary (less than twice weekly exercising) women aged 65-75 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431002

Contacts
Contact: Marian Brlecic 604-875-4111 ext 69056 mbrlecic@interchange.ubc.ca

Locations
Canada, British Columbia
Vancouver Coastal Health Research Institute Research Pavilion
Vancouver, British Columbia, Canada
YMCA
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Provincial Health Services Authority
Investigators
Principal Investigator: Karim Miran-Khan, Ph.D University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia ( Dr. Maureen Ashe )
Study ID Numbers: H05-70624
Study First Received: January 31, 2007
Last Updated: September 24, 2008
ClinicalTrials.gov Identifier: NCT00431002     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Exercise
Resistance training

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:
Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on May 07, 2009