Effect of combined exercise therapy and isoflavone supplementation on prevention of osteoporosis
| ISRCTN | ISRCTN76916228 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76916228 |
| ClinicalTrials.gov number | NCT00204425 |
| Secondary identifying numbers | MCT-68095 |
- Submission date
- 09/09/2005
- Registration date
- 09/09/2005
- Last edited
- 01/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Philip David Chilibeck
Scientific
Scientific
University of Saskatchewan
College of Kinesiology
87 Campus Drive
Saskatoon
S7N 5B3
Canada
| Phone | +1 306 343 6577 |
|---|---|
| phil.chilibeck@usask.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Scientific title | Effect of combined exercise therapy and isoflavone supplementation on prevention of osteoporosis: a randomised controlled trial |
| Study objectives | Exercise training and isoflavone supplementation will be additive for increasing bone mineral density. Please note that as of 06/03/2009 the anticipated end date in this record was amended; the initial end date at the time of registration was 01/12/2007. |
| Ethics approval(s) | University of Saskatchewan Biomedical Research Ethics Board (Bio-REB) gave approval on the 1st August 2003 |
| Health condition(s) or problem(s) studied | Osteoporosis |
| Intervention | Group 1: exercise training plus isoflavone placebo Group 2: exercise training placebo (flexibility program) plus isoflavone therapy Group 3: exercise training plus isoflavone therapy Group 4: exercise training placebo plus isoflavone placebo The exercise training intervention will consist of weight training combined with walking. The exercise training placebo will consist of home-based flexibility program (a type of training that has no effect on bone mineral). All participants will be required to fill out and return to the study staff daily activity logs throughout the study. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Isoflavone |
| Primary outcome measure | Lumbar spine bone mineral density |
| Secondary outcome measures | 1. Bone mineral density of the proximal femur and whole body 2. Bone quality of the calcaneus 3. Geometry the proximal femur 4. Lean tissue mass 5. Fat mass 6. Body mass index 7. Waist girth 8. Skinfolds 9. Blood lipids 10. Breast density 11. Endometrial thickness 12. Menopausal symptoms 13. Physical activity levels 14. Muscular strength 15. Self-paced walking ability 16. Balance and flexibility |
| Overall study start date | 14/09/2004 |
| Completion date | 30/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 360 (351 at end of recruitment) |
| Key inclusion criteria | Post-menopausal women (age range of approximately 45 to 70 years) |
| Key exclusion criteria | 1. Diagnosed osteoporosis 2. Previous fragility fractures 3. Above normal bone mineral density (equal to or above the young adult mean) 4. Breast or endometrial cancers 5. Women taking bisphosphonates, hormone replacement therapy, selective estrogen receptor modulators, parathyroid hormone (PTH), or calcitonin in the past 12 months 6. Taking corticosteroids or diuretics 7. Diagnosed Crohns Disease and Cushing Disease 8. Women with allergies to soy 9. Severe osteoporosis 10. Smokers 11. Currently participating in vigorous exercise programs |
| Date of first enrolment | 14/09/2004 |
| Date of final enrolment | 30/05/2008 |
Locations
Countries of recruitment
- Canada
Study participating centre
University of Saskatchewan
Saskatoon
S7N 5B3
Canada
S7N 5B3
Canada
Sponsor information
University of Saskatchewan (Canada)
Not defined
Not defined
105 Administration Place
Saskatoon
S7N 5A2
Canada
| Website | http://www.usask.ca/ |
|---|---|
"ROR" |
https://ror.org/010x8gc63 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-68095)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2013 | 01/02/2019 | Yes | No |
Editorial Notes
01/02/2019: Publication reference added
