Effects of a Resistance Exercise Programme on Risk of Osteoporosis and Osteoarthritis in Females
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in Femoral neck bone mineral density from baseline
研究概览
简要总结
Osteoarthritis (degenerative joint disease) and osteoporosis (weak and fragile bones) are common conditions, particularly in women after menopause, and become even more common as we get older. Aging is also associated with sarcopenia, the progressive loss of muscle strength and mass with age. In this three-arm study, the effect of resistance exercise programs with different parameters (such as velocity and load) on various outcomes, including structural changes (bone mineral density, cartilage composition, muscle size), physical function, and biomarkers will be compared.
详细描述
Resistance exercise is effective in improving several risk factors for osteoporosis and osteoarthritis, and is recommended to prevent and manage both conditions, and is also known to counteract sarcopenia. Overall, there is little and inconsistent evidence on the effects of exercise parameters (such as velocity) for the prevention of osteoporosis and osteoarthritis, neither is there a comparison of different velocities on structural parameters and biomarkers. Although osteoporosis and osteoarthritis take a long time to develop, it is possible to look at changes in risk using scans of bones and joints -Dual-Energy X-ray absorptiometry (DXA), peripheral Quantitative Computed Tomography (pQCT), and Magnetic Resonance Imaging (MRI)-, blood and/or urine samples and symptoms.
This study aims to examine the effect of two different resistance exercise interventions (explosive high-velocity vs high-load low-velocity training) on structural changes on bone, articular knee and/or hip cartilage and muscle, as well as biomarkers.
The study will be a 32-week long randomized controlled trial including two exercise groups and one non-exercising control group.
Screening and baseline measurements will then be taken when anonymization is completed. Once participants have completed baseline testing, participants will be randomly assigned to one of the exercise groups or control groups using a block randomization technique. Participants will choose an envelope, prepared in batches of 11, which will contain a note saying either 'ballistic' or 'conventional or 'control' with a ratio of 4:4:3. This is to allow for greater drop-out in the exercise groups. It is not possible to blind the participant or researchers supervising the intervention to the group allocation.
The required exercise program involves two supervised sessions per week at Loughborough University, each lasting no longer than 60 minutes per session. Each session will involve 30-40 minutes of exercise and time to check any symptoms or queries with participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 50-70 years;
- •Experienced last menstrual cycle, hormonal contraception or menopausal hormone replacement therapy at least five years ago;
- •Independent living and able to come into the university;
- •Healthy women: not previously diagnosed with osteoporosis or knee osteoarthritis, other major medical conditions;
- •Able to understand English.
排除标准
- •Any existing symptomatic knee, hip, back injury or any medical conditions or injuries which would affect the ability or safety to perform exercise or influence bone/cartilage, including unstable angina, uncontrolled hypertension, a history of heart failure, and a history of cardiovascular disease and conditions;
- •Taking medication affecting bone/cartilage metabolism;
- •Regular (>once per week on average) participation in resistance training with loading greater than bodyweight or in high impact (impact greater than jogging);
- •Blood pressure exceeding 150/90 mmHg;
- •BMI > 30 kg/m2;
- •Contraindications to MRI or DXA (e.g. Metallic implants);
- •Osteoporotic (FRAX score according to which the participant would be advised to seek treatment);
- •Fracture within the past year.
研究组 & 干预措施
Ballistic resistance exercise training
This arm will perform the exercises in a hack squat machine using low loads and explosive high-velocity (as if trying to jump)
干预措施: Ballistic Resistance Lower Body Strength Training (Other)
Conventional resistance exercise training
This arm will perform the exercises in a hack squat machine using high-load and low-velocity (conventional training)
干预措施: Conventional Resistance Lower Body Strength Training (Other)
Control
Continue usual life
结局指标
主要结局
Change in Femoral neck bone mineral density from baseline
时间窗: 32nd week
(g/cm\^2) measured by DXA
Change in Femoral neck bone mineral content from baseline
时间窗: 32nd week
(g) measured by DXA
次要结局
- Lower limb velocity(Baseline, 16th and 32nd weeks)
- Bone Mineral Content (Spine)(Baseline, 16th and 32nd weeks)
- bone mineral density (Lower Leg)(Baseline, 16th and 32nd weeks)
- Bone mineral content (Total body)(Baseline, 16th and 32nd weeks)
- bone mineral density (Forearm)(Baseline, 16th and 32nd weeks)
- Bone Mineral Density (Femur)(Baseline, 16th and 32nd weeks)
- Bone Mineral Density (Spine)(Baseline, 16th and 32nd weeks)
- Bone mineral content (Lower leg)(Baseline, 16th and 32nd weeks)
- Bone Mineral Content (Femur)(Baseline, 16th and 32nd weeks)
- trabecular bone density (Lower leg)(Baseline, 16th and 32nd weeks)
- cortical bone subdensity (Lower leg)(Baseline, 16th and 32nd weeks)
- cortical bone subdensity (Forearm)(Baseline, 16th and 32nd weeks)
- cortical bone density (Forearm)(Baseline, 16th and 32nd weeks)
- bone mineral density (Total Body)(Baseline, 16th and 32nd weeks)
- cortical bone density (Lower leg)(Baseline, 16th and 32nd weeks)
- Pain, stiffness, and physical function of the hip and knee(Baseline, 16th and 32nd weeks)
- Physical activity and inactivity level(Baseline, 16th and 32nd weeks)
- total bone density (Lower leg)(Baseline, 16th and 32nd weeks)
- bone mineral content (Forearm)(Baseline, 16th and 32nd weeks)
- trabecular bone density (Forearm)(Baseline, 16th and 32nd weeks)
- total bone density (66% of Lower leg)(Baseline, 16th and 32nd weeks)
- Lower limb power(Baseline, 16th and 32nd weeks)
- Lower limb force(Baseline, 16th and 32nd weeks)
- Triceps surae cross-sectional area(Baseline and 32nd week)
- Mobility/agility(Baseline, 16th and 32nd weeks)
- Pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life following knee injury(Baseline, 16th and 32nd weeks)
- Physical Activity Level(Baseline, 16th and 32nd weeks)
- total bone density (Forearm)(Baseline, 16th and 32nd weeks)
- bone total density (Forearm)(Baseline, 16th and 32nd weeks)
- Change in bone turnover biomarkers (CTX-1 and P1NP) in bodily samples(Baseline, 16th and 32nd weeks)
- Daily calcium intake(Baseline, 16th and 32nd weeks)
- Static postural sway(Baseline, 16th and 32nd weeks)
- bone total density (Lower leg)(Baseline, 16th and 32nd weeks)
- cortical density (Lower leg)(Baseline, 16th and 32nd weeks)
- T2 relaxation time(Baseline and 32nd week)
- cartilage thickness(Baseline and 32nd week)
- Lower extremity functioning(Baseline, 16th and 32nd weeks)
- Static postural sway (elliptical area)(Baseline, 16th and 32nd weeks)
- Quadriceps cross-sectional area(Baseline and 32nd week)
- Change in bone turnover markers (CTX-1 and PINP) in bodily samples(Baseline, 16th and 32nd weeks)
- Change in serum biomarkers (OPG, DKK1, irisin, IL-6, C2C, PIICP) in serum samples (exploratory, post hoc)(Baseline, 16th and 32nd weeks)
研究者
Katherine Brooke-Wavell
Senior Lecturer in Human Biology
Loughborough University