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The Effect of Aerobic Exercise on Bone Turnover Markers in Postmenopausal Patients

U

UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL

Status

Completed

Conditions

Postmenopausal Osteopenia

Treatments

Other: cholecalciferol
Other: calcium carbonate
Other: aerobic exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT06866561
HSBY-FTR-KND-01

Details and patient eligibility

About

The aim of the study was to evaluate the effect of light-moderate aerobic exercise on BMD in postmenopausal osteopenic women using bone formation-resorption markers. Participants were randomized into two groups as aerobic exercise and control groups and followed for 12 weeks. At the beginning and at the 12th week, bone formation-resorption markers including procollagen type 1 N-terminal propeptide (P1NP), cross-linked C-telopeptide of type 1 collagen (CTX), osteocalcin, malondialdehyde, non-bone-specific total alkaline phosphatase, 25(OH)D3 and oxidative markers such as parathyroid hormone (PTH) were evaluated in serum and whether there was a difference between the 2 groups.

Full description

The aim of the study was to investigate the effects of light and moderate intensity aerobic exercise on bone mineral density (BMD) in postmenopausal osteopenic women using bone formation and resorption markers. In a prospective, randomized, controlled, single-blind clinical trial, women aged 45-65 years with BMD T scores between -1 and -2.5 measured by double X-ray absorptiometry (DXA) were included in the study after evaluation of exclusion criteria and the women were divided into 2 groups: aerobic exercise group and control group (exercise, n=25; control, n=25). The exercise group participated in a supervised aerobic exercise program consisting of walking on a treadmill for 30 minutes per day, 3 days per week, at an intensity of 40-60% of maximal heart rate for 4 weeks. Additionally, they were shown an exercise program at the initial assessment that included balance, posture, and endurance exercises using body weight and weights to be performed 3 days a week, with 3 sets of 10 repetitions. The control group did not participate in any exercise program.All patients were prescribed 2000 IU of vitamin D (cholecalciferol) and 1200 mg of calcium carbonate daily for 12 weeks. Serum levels of biomarkers of bone formation and resorption including procollagen type 1 N-terminal propeptide (P1NP), cross-linked C-telopeptide of type 1 collagen (CTX), osteocalcin, malondialdehyde, non-bone-specific total alkaline phosphatase, 25(OH)D3 and oxidative markers such as parathyroid hormone (PTH) were examined in all patients at baseline and 12-week follow-up. Nottingham Health Profile questionnaire (NHP), Visual analog scale (VAS), 6-minute walk test (6MWT), International Physical Activity Questionnaire (short form) (IPAQ), Berg Balance Scale (BBS), 30-second sit-to-stand test questionnaires (30s-CST) tests were performed at baseline and 12 weeks to evaluate the participants' quality of daily life, pain, walking speed, physical activity level and balance.

Enrollment

45 patients

Sex

Female

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Postmenopausal women from Türkiye aged 45-65 years,
  • Bone mineral density (BMD) T-scores between -1 and -2.5 ( measured by dual-energy X-ray absorptiometry)

Exclusion criteria

  • Vertebral compression fracture,
  • A history of traumatic or nontraumatic fractures in the past year,
  • Thyroid hormone disorders,
  • Parathyroid hormone disorders,
  • Liver function disorders,
  • Kidney function disorders,
  • Chronic heart failure,
  • A history of malignancy,
  • A history of rheumatological diseases,
  • Corticosteroid use,
  • Immunosuppressive drug use,
  • Anticonvulsant and heparin use,
  • Antiresorptive or anabolic agent treatments use
  • Hormone replacement therapy use
  • Those who could not complete sessions due to mechanical pain exacerbated during aerobic exercise on a treadmill (such as knee and hip osteoarthritis, back pain, etc)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

45 participants in 2 patient groups

exercise group
Active Comparator group
Description:
The exercise group participated in a supervised aerobic exercise program consisting of walking on a treadmill for 30 minutes per day, 3 days per week, at an intensity of 40-60% of maximal heart rate for 4 weeks.
Treatment:
Other: aerobic exercise
Other: calcium carbonate
Other: cholecalciferol
Control group
Other group
Description:
The control group did not participate in any exercise program.
Treatment:
Other: calcium carbonate
Other: cholecalciferol

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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