The Effect of Exercise With or Without Antiresorptive Therapy, on Bone Properties in Postmenopausal Women With Low BMD - Randomised Controlled Unilateral Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Femoral neck bone mineral content BMC
研究概览
简要总结
Osteoporosis is a systemic bone disorder characterised by a reduced bone mass and structural deterioration, increasing the risk of fragility fractures, particularly in women post-menopause. Bone mass and structure can be assessed by scans.
Antiresorptive medications are commonly prescribed to reduce bone resorption, preventing further bone loss and thus reducing the possibility of fracture. Exercise can also benefit bone mass and structure but current evidence do not show whether exercise is more, or less, effective in combination with antiresorptive medication.
This study will compare the effect of a brief, home-based exercise programme on bone mineral and structural properties in women taking/ not taking antiresorptive medication.
详细描述
Exercise can benefit bone density and induce structural changes, leading to a decrease in fracture risk. High-impact exercise is often recommended for promoting bone health as it generates the brief, high strains that stimulate bone adaptation. Brief multidirectional hopping exercises have been demonstrated to be a practical and sustainable intervention with older men, pre- and postmenopausal women. They allow exercise to be conducted on one leg, whilst changes in the other leg can be used as a control to compare what would happen without exercise.
The effects of exercise on bone density and structure may be different in women taking osteoporosis medication, but few studies have examined this group. This study thus aims to evaluate the effects of exercise on bone density and structure according to osteoporosis medication use.
The study will be a 12-month long randomised controlled trial including two groups: with and without antiresorptive osteoporosis medication for at least 12 months. Participants must not plan to change their treatment choices during the 12-month study. All participants will complete a 12-month unilateral hopping exercise intervention.
Screening and baseline measurements will include dual X-ray absorptiometry (DXA) and computed tomography (CT) scans of the hip, blood collection, hop assessment and questionnaires. Eligible participants will then be invited to commence the exercise intervention and randomly allocated an exercise leg, with the contralateral leg being untrained to provide a control leg. Randomisation of exercise and control legs will be performed by selecting an opaque sealed envelopes which contain "R" or "L" letters. It is not possible to blind the participant or researchers supervising the intervention to leg allocation.
An initial familiarisation session will be conducted under supervision. The exercise intervention involves a home-based exercise programme starting at three days per week, with the goal of increasing to seven days per week. It will begin with a warm-up targeting the legs and lower back, followed by a progressive exercise regimen that will gradually increase in technique, intensity, and frequency to ensure safety. It will be personalised according to the participants' physical abilities and responses during or after the exercise. Weekly supervised group sessions will be offered, and used to advise participants on progression of exercise. An exercise logbook will monitor adherence. A questionnaire on any injuries, soreness, or discomfort will be administered monthly online or by phone. Participants will be instructed to reduce intensity and frequency or discontinue exercise if they experience any adverse symptoms or discomfort.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The researcher conducting imaging assessments and analyses will remain blinded.
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 55-75 years old
- •>4y since menopause/hysterectomy/oophorectomy.
- •Baseline femoral neck or lumber spine BMD T-score between -1 and -
- •Able to complete the hopping exercises.
- •Have no regular involvement for more than once/week in:
- •Strength, powerlifting or high load resistance exercise.
- •High to moderate impact exercise that known to involve ground reaction forces 2 to 4 times greater than body weight (e.g. Jogging).
- •Treatment group: taking antiresorptive treatment for osteoporosis continuously for at least 12 months, and who intend to continue this medication for the rest of the study.
- •Control group: not taking any medication affecting bone and no intention to commence such medication for the rest of the study.
排除标准
- •Body mass index (BMI) >35 kg/m2
- •Any medical condition, surgery, or injuries that contraindicate exercises including lower limb or back pain, knee or hip osteoarthritis.
- •Vertebral fracture or multiple low trauma fractures (recent expert consensus recommends lower impact exercise for these groups)
- •Replacement of hip joint(s)
研究组 & 干预措施
Without any medication affecting bone
Participants in this arm are postmenopausal women with low bone density who are not taking any bone medication for at least 12 months. They will participate in a 12-month supervised high impact unilateral hopping exercise.
干预措施: EXERCISE TRAINING (Behavioral)
With osteoporosis medication (antiresorptive )
Participants in this arm are postmenopausal women with low bone density who are taking antiresorptive medication for at least 12 months. They will participate in a 12-month supervised high impact unilateral hopping exercise.
干预措施: EXERCISE TRAINING (Behavioral)
With osteoporosis medication (antiresorptive )
Participants in this arm are postmenopausal women with low bone density who are taking antiresorptive medication for at least 12 months. They will participate in a 12-month supervised high impact unilateral hopping exercise.
干预措施: Antiresorptive medication (routine clinical care) (Drug)
结局指标
主要结局
Femoral neck bone mineral content BMC
时间窗: Baseline, 6 months and 12 months
(g) measured by DXA
Femoral neck bone mineral density BMD
时间窗: Baseline, 6 months and 12 months
(g/cm\^2) measured by DXA
次要结局
- Total hip bone mineral content BMC(Baseline, 6 months and 12 months)
- Total hip bone mineral density BMD(Baseline, 6 months and 12 months)
- Lumbar spine bone mineral content BMC(Baseline, 6 months and 12 months)
- Lumbar spine bone mineral density BMD(Baseline, 6 months and 12 months)
- Prevalent vertebral fracture(Baseline, 6 months and 12 months)
- Whole body composition(Baseline, 6 months and 12 months)
- Total fat mass(Baseline, 6 months and 12 months)
- Lean mass(Baseline, 6 months and 12 months)
- Tibia distal (4%) Total volumetric bone density vBMD(Baseline, 6 months and 12 months)
- Tibia distal (4%) trabecular density vBMD(Baseline, 6 months and 12 months)
- Tibia distal (4%)Total bone area(Baseline, 6 months and 12 months)
- Tibia shaft (66%) cortical content per 1 mm(Baseline, 6 months and 12 months)
- Tibia shaft (66%) cortical thickness(Baseline, 6 months and 12 months)
- Tibia shaft (66%) cortical vBMD(Baseline, 6 months and 12 months)
- Femoral neck integral BMC(Baseline and 12 months)
- Femoral neck cortical BMC(Baseline and 12 months)
- Femoral neck trabecular BMC(Baseline and 12 months)
- Proximal femur cortical thickness(Baseline and 12 months)
- Plasma bone turnover biomarkers (resorption marker)(Baseline, 6 months and 12 months)
- Hop performance (ground reaction force).(Baseline, 6 months and 12 months)
- Total Bone-specific Physical Activity Questionnaire (BPAQ) score(Baseline and 12 months)
- Daily calcium intake(Baseline, 6 months and 12 months)
- Fall and balance confidence(Baseline, 6 months and 12 months)
- Trochanter BMD(Baseline, 6month and 12month)
- Trochanter BMC(Baseline, 6month and 12month)
- Tibia shaft (66%) cortical area(Baseline, 6 months and 12 months)
- Tibia shaft (66%) Periosteal circumference(Baseline, 6 months and 12 months)
- Tibia shaft (66%) Endosteal circumference(Baseline, 6 months and 12 months)
- Tibia shaft (66%) Axial area moment of inertia(Baseline, 6 months and 12 months)
- Tibia shaft (66%) Moment of resistance(Baseline, 6 months and 12 months)
- Tibia shaft (66%) Total bone area(Baseline, 6 months and 12 months)
- Tibia shaft (66%) Strength Strain Index(Baseline, 6 months and 12 months)
- Trochanter integral BMC(Baseline and 12 months)
- Trochanter cortical BMC(Baseline and 12 months)
- Trochanter trabecular BMC(Baseline and 12 months)
- Intertrochanter integral BMC(Baseline and 12 months)
- Intertrochanter cortical BMC(Baseline and 12 months)
- Intertrochanter trabecular BMC(Baseline and 12 months)
- Mid-femoral neck geometry(Baseline and 12 months)
研究者
Katherine Brooke-Wavell
Professor
Loughborough University