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High Intensity Strength Training & Bone Mineral Density in Young Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01482130
First received: November 16, 2011
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  Purpose

The current guidelines emphasize the prevention of bone loss, by building up bone mass in young age, as one of the most important measures to reduce the incidence of osteoporosis. Strength training and "explosive" exercises have been shown to have beneficial effects on bone mass and bone metabolism in both young and postmenopausal women. However, meta-analysis concludes that it is still unclear what type of exercises, intensity and execution that is most effective for skeletal adaptations. The following study will examine the effect of 12 weeks of heavy, explosive strength training on bone mineral density and bone metabolism in young, healthy girls aged 18-30 years.


Condition Intervention
Osteoporosis
 Behavioral: Heavy, explosive strength training
Behavioral: recommendations

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing Osteoporosis: The Effect of High Intensity Strength Training on Bone Mineral Density in Young and Healthy Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    (Dual X-ray Absorptiometry)


Secondary Outcome Measures:
  • Serum markers of bone metabolism [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Blood samples will be drawn for analyses of bone metabolism and markers of bone formation; osteoprotegerin (OPG) and Type I procollagen N-terminal propeptide (PINP). Furthermore, Type 1 collagen C-breakdown products (CTX) and receptor activator of NF kappa B ligand (RANKL) which are the key regulators of bone resorption, will be analyzed at the start and end of the study.

  • Body composition [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Lean- versus fat mass, measured by Dual X-ray Absorptiometry (DXA).

  • Maximal muscle strength [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Measured as one repetition maximum in a squat exercise machine.

  • Rate of force development [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Maesured dynamic in a squat exercise maschine, and isometric at 90 degree angle in the knee joint.


Enrollment: 30
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Training group
All participants in the training group will pursue a 12 weeks of strength training.
 Behavioral: Heavy, explosive strength training
All participants of the training group will pursue a 12 weeks of heavy, explosive strength training, 3 sessions a week for a total of 36 sessions. The training session will include one squat exercise only, which allows muscle contraction of the quadriceps from a 90° bend at the knees to straight legs.
Controls
The control group will be encouraged to follow a training program according to recommended exercise guidelines
 Behavioral: recommendations

The control group will be encouraged to follow a training program according to recommended exercise guidelines:

  • Weight bearing activities (walking, jogging or strength training)
  • 30 - 60 minutes, 3 - 5 times each week
  • A total of 2 - 3 hours each week should be achieved

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants include young and healthy women between the ages of 18-30, who have not engaged in strength training for the last 6 months.

Exclusion Criteria:

  • Subjects will be excluded from the study if they have any condition that preclude them from taking part in the exercise testing procedures or the 24 week exercise program or if they fail to obtain the required amount of training sessions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482130

Locations
Norway
Norwegian University of Science and Technology
Trondheim, Sor.tronderlag, Norway, 7030
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Director: Unni Syversen, MD, PhD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01482130     History of Changes
Other Study ID Numbers: REK-2011/2039
Study First Received: November 16, 2011
Last Updated: September 19, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Norwegian University of Science and Technology:
Exercise
osteoporosis
prevention

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

ClinicalTrials.gov processed this record on May 23, 2013