Effects of a 3-month Weight-bearing and Resistance Exercise Training on Circulating Osteoprogenitor Cells and Bone Formation Markers in Postmenopausal Women With Low Bone Mass.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Serum Sclerotin Levels
研究概览
简要总结
The aim of our research was to define both in vivo and in vitro whether and to what extent an high-impact exercise program would affect bone cell turnover and improve the QoL in osteopenic postmenopausal women.
详细描述
Subjects were selected among those attending the "Bone and Mineral Metabolism Disorders" Clinic of Perugia University, Italy, since May 2nd 2015 and January 31st 2016. A total of 33 post-menopausal women volunteered to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 52 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal
- •bone mineral density T-score less than -1 but more than -2.5 in the total hip or lumbar spine (L1-L4) by dual energy x-ray absorptiometry
- •be able to attend an exercise program 2 times per week over the 3-month period
- •stated availability throughout the entire study period
排除标准
- •secondary causes of bone loss such as osteomalacia, glucocorticoid medication
- •co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition
- •physical or orthopaedic disabilities that would place the subject at risk or limit their ability to perform exercise
- •a past vertebral fracture
- •history of chronic diseases, such as renal, hepatic, cardiac, and rheumatic diseases
- •current or prior use of drugs that could interfere with bone mass (i.e. glucocorticoids, antiresorptive drugs and hormonal replacement therapy)
研究组 & 干预措施
Physical Exercise
The exercise program was performed at C.U.R.I.A.Mo. Institute of "Università degli Studi di Perugia". Twenty-four exercise sessions were provided, carried out twice a week for three months. Each session was supervised by two graduated trainers and two medical doctors with a maximum attendance of 5 patient/group.
Each session lasted 45 minutes divided into 15 minutes of aerobic activity and 30 minutes of weight-bearing and resistance activities.
This latter section was specifically projected for adults and older adults with increased risk of fractures and was intended to improve muscle strength and flexibility, balance and, as a result, to prevent the risk of falls.
干预措施: Physical exercise (Other)
No additional physical exercise
Usual recommendations for prevention of fractures in adults and elderly.
结局指标
主要结局
Serum Sclerotin Levels
时间窗: Baseline - W4
Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism.
Sclerostin
时间窗: Week 4 - Week 12
Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism.
Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP)
时间窗: Baseline - Week 4
P1NP is the most reliable serum marker of bone formation commercially available at the moment
Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX)
时间窗: Week 4 - Week 12
Serum carboxy terminal telopeptide of collagen type I (sCTX) is one of the most sensitive and specific bone resorption markers of osteoclast-mediated collagen degradation.
Variation in Circulating Osteoprogenitor Cells (OPCs).
时间窗: Week 4 - Week 12
Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).
Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP).
时间窗: Week 4 - Week 12
P1NP is the most reliable serum marker of bone formation, commercially available at the moment.
Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX)
时间窗: Baseline - Week 4
Serum carboxy-terminal telopeptide of collagen type I (sCTX) is one of the most sensitive and specific bone resorption markers of osteoclast-mediated collagen degradation
Variation in Circulating Osteoprogenitor Cells (OPCs)
时间窗: Baseline - Week 4
Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).
次要结局
- Variation in Health-related Quality of Life (QoL)(Baseline - Week 4)
- Variation in Health-related Quality of Life (QoL).(Week 4 - Week 12)
研究者
Rita Lombardini
Principal Investigator
University Of Perugia