The Effect of Aerobic Exercise on Bone Formation and Resorption Markers And The Quality of Life Tests in Postmenopausal Osteopenic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The serum levef of Procollagen type 1 N-terminal propeptide (P1NP) (ng/ml)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Patients who met the inclusion criteria were randomized into 2 groups with the investigator blinded.
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
exercise group
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.
干预措施: aerobic exercise (Other)
Control group
The control group did not participate in any exercise program.
干预措施: calcium carbonate (Other)
Control group
The control group did not participate in any exercise program.
干预措施: cholecalciferol (Other)
exercise group
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.
干预措施: calcium carbonate (Other)
exercise group
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.
干预措施: cholecalciferol (Other)
结局指标
主要结局
The serum levef of Procollagen type 1 N-terminal propeptide (P1NP) (ng/ml)
时间窗: From enrollment to the end of treatment at 12 weeks
Bone turnover markers allow for the independent assessment of bone resorption and formation by measuring their concentrations in blood and urine. These markers provide early response evaluation posttreatment of osteoporosis compared to measuring BMD. The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommend evaluating P1NP for bone formation activity and evaluating CTX-1 concentrations for bone resorption activity. In the study,the investigators chose walking exercise as an aerobic exercise that can be easily applied to people of all age groups and those with comorbidities. For these reasons, as the primary outcome of the study, the investigators aimed to measure the effects of aerobic exercise as a treatment method that can be recommended to the majority of patients, as bone turnover markers P1NP, CTX, OCN and total ALP respond quickly to treatment.
The serum levef of Cross-linked C-telopeptide of type I collagen (CTX) (ng/ml)
时间窗: From enrollment to the end of treatment at 12 weeks
During bone resorption, components of bone tissue are catabolized by osteoclasts. The released components are released into the bone microenvironment and secreted into the bloodstream. Some of them are also excreted in the urine. The level of C-telopeptide type 1 collagen(CTX)(ng/ml) can be measured in serum from these products. . The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommend evaluating CTX-1 concentrations for bone resorption activity.
The serum levef of Osteocalcin(OCN) (ng/ml)
时间窗: From enrollment to the end of treatment at 12 weeks
During bone formation, osteoblasts fill the cavities with collagen-rich tissue and the molecules formed during their production are secreted into the blood. These products are; Type 1 procollagen N-terminal propeptide (P1NP), bone alkaline phosphatase, Osteocalcin, Type-1 procollagen C-terminal propeptide. These molecules also show bone formation activity.
The serum levef of nonbone-specific total alkaline phosphatase (ALP) (U/L)
时间窗: From enrollment to the end of treatment at 12 weeks
During bone formation, osteoblasts fill the cavities with collagen-rich tissue and the molecules formed during their production are secreted into the blood. These products are; Type 1 procollagen N-terminal propeptide (P1NP), bone alkaline phosphatase, Osteocalcin, Type-1 procollagen C-terminal propeptide. These molecules also show bone formation activity.
次要结局
- Serum level of Malondİaldehyde(MDA) (ng/ml) as a Oxidative stress marker(From enrollment to the end of treatment at 12 weeks)
- Nottingham Health Profile questionnaire (NHP)(From enrollment to the end of treatment at 12 weeks)
- Visual analog scale (VAS)(From enrollment to the end of treatment at 12 weeks)
- 6-minute walk test (6MWT)(From enrollment to the end of treatment at 12 weeks)
- International Physical Activity Questionnaire (short form)(IPAQs)(From enrollment to the end of treatment at 12 weeks)
- Berg Balance Scale (BBS)(From enrollment to the end of treatment at 12 weeks)
- 30-second sit-to-stand test questionnaires(30s-CST)(From enrollment to the end of treatment at 12 weeks)
- The serum levef of Parathyroid hormone (PTH)(pg/ml)(From enrollment to the end of treatment at 12 weeks)
研究者
KÜBRA NUR DENİZ
Principal Investigator
UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL