ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Exercise and Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00663104
Recruitment Status : Terminated
First Posted : April 22, 2008
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
Siemens-Betriebskrankenkasse
Information provided by (Responsible Party):
Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School

Brief Summary:
The aim of the study is to compare the effect of a progressive, periodized exercise training designed to impact bone, CHD-risk-factors and menopausal complaints versus the combined effect of exercise and "phytoestrogen" (cimicifuga racemosa; CR). After randomization, 84 females 1-3 year postmenopausal with no medication or illness affecting bone metabolism exercise over 12 months (EG; 42 with, 42 without CR), 42 women serve as wellness-control. Three group training sessions/week will be performed in the EG. Both groups will be individually supplemented with calcium and Vit-D (cholecalciferol).

Condition or disease Intervention/treatment Phase
Bone Diseases Metabolic Syndrome X Coronary Disease Behavioral: exercise Behavioral: exercise + cimicifuga racemosa Behavioral: wellness control, placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Exercise and Exercise + Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause
Study Start Date : April 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : November 2009


Arm Intervention/treatment
Active Comparator: 1
exercise (3 sessions/week)
Behavioral: exercise
exercise: 3 joint sessions/week for 12 months
Active Comparator: 2
exercise and "phytoestrogen" (cimicifuga racemosa)
Behavioral: exercise + cimicifuga racemosa
exercise: 3 sessions/week for 12 months,cimicifuga racemosa (40 mg/d)
Placebo Comparator: 3
wellness control, placebo
Behavioral: wellness control, placebo
2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months, placebo



Primary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: baseline, 12 month ]

Secondary Outcome Measures :
  1. body composition [ Time Frame: baseline, 12 month ]
  2. blood lipids, glucose [ Time Frame: baseline, 12 month ]
  3. blood pressure [ Time Frame: baseline, 12 month ]
  4. 10 year CHD-risk [ Time Frame: baseline, 12 months ]
  5. menopausal complaints [ Time Frame: baseline, 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1-3 years early postmenopausal
  • Caucasian race

Exclusion Criteria:

  • CHD-diseases
  • thrombosis, embolism
  • fractures at lumbar spine or hip
  • secondary osteoporosis
  • hyperparathyroidism
  • medication, diseases with impact on muscle or bone
  • cancer and hormone derived malign diseases
  • weight reduction of > 5 kg during the last 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663104


Locations
Germany
Institute of Medical Physics
Erlangen, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Siemens-Betriebskrankenkasse
Investigators
Principal Investigator: Michael Bebenek, MS University of Erlangen-Nürnberg Medical School
Study Director: Wolfgang Kemmler, PhD University of Erlangen-Nürnberg Medical School
Study Chair: Willi A Kalender, Professor, PhD University of Erlangen-Nürnberg Medical School

Publications:
Responsible Party: Wolfgang Kemmler, Principal Investigator, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00663104     History of Changes
Other Study ID Numbers: OFZ-Trace
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School:
early menopause
exercise
phytoestrogen
bone
CHD-risk factors

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Coronary Disease
Coronary Artery Disease
Bone Diseases
Menopause, Premature
Primary Ovarian Insufficiency
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Musculoskeletal Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists