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

• Sponsor: University of Erlangen-Nürnberg Medical School (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00663104
• Collaborator: Siemens-Betriebskrankenkasse (Industry)
• Enrollment: 126
• Location: 1
• Arms: 3
• Duration (Months): 19
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Apr 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Bone Mineral Density [baseline, 12 month]

Secondary Outcome Measures

1. body composition [baseline, 12 month]

2. blood lipids, glucose [baseline, 12 month]

3. blood pressure [baseline, 12 month]

4. 10 year CHD-risk [baseline, 12 months]

5. menopausal complaints [baseline, 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kemmler W, Lauber D, Weineck J, Hensen J, Kalender W, Engelke K. Benefits of 2 years of intense exercise on bone density, physical fitness, and blood lipids in early postmenopausal osteopenic women: results of the Erlangen Fitness Osteoporosis Prevention Study (EFOPS). Arch Intern Med. 2004 May 24;164(10):1084-91.
• Kemmler W, von Stengel S, Weineck J, Lauber D, Kalender W, Engelke K. Exercise effects on menopausal risk factors of early postmenopausal women: 3-yr Erlangen fitness osteoporosis prevention study results. Med Sci Sports Exerc. 2005 Feb;37(2):194-203.
• von Stengel S, Kemmler W, Kalender WA, Engelke K, Lauber D. Differential effects of strength versus power training on bone mineral density in postmenopausal women: a 2-year longitudinal study. Br J Sports Med. 2007 Oct;41(10):649-55; discussion 655. Epub 2007 Jun 5. Erratum in: Br J Sports Med. 2007 Dec;41(12):926.

• Responsible Party: Wolfgang Kemmler, Principal Investigator, University of Erlangen-Nürnberg Medical School
• ClinicalTrials.gov Identifier: NCT00663104
• Other Study ID Numbers: OFZ-Trace
• First Posted: Apr 22, 2008
• Last Update Posted: May 28, 2015
• Last Verified: May 1, 2015

• Keywords provided by Wolfgang Kemmler, Principal Investigator, University of Erlangen-Nürnberg Medical School: early menopause; exercise; phytoestrogen; bone; CHD-risk factors
• Additional relevant MeSH terms: Bone Diseases; Menopause, Premature; Primary Ovarian Insufficiency; Coronary Disease; Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of May 28, 2015