Effects of High-Intensity Interval Training on Bone Health, Physical Fitness and Quality of Life in Elderly Women With Osteopenia: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Bone mineral density
研究概览
简要总结
Osteoporosis is an age-related disease, characterized by a decreased bone mass and an increased risk of fragility fractures. Osteoporosis leads to increasing mortality, disabilities, morbidity of chronic pain, and the cost of health and social care, as well as decreasing the quality of life from reduced independence and hindered physical, mental, and social well-being.
A recent review and meta-analysis, investigating the association between physical activity and osteoporosis prevention in elderly people, indicated that the traditional exercise interventions (i.e., resistance training) were undertaken for 60+ mins, 2-3 times/week for 7+ months. However, participation rates remain low in these exercise programs among older adults, in part due to a need for specialized equipment and correct techniques to prevent injury. In addition, low motivation and associated compliance with such conventional exercise is problematic among older adults.
Considering there is little evidence of HIIT benefits related to older women with osteopenia, the current study aims to evaluate the effectiveness of a 24-week HIIT intervention on bone mineral density, bone turnover markers and other health-related outcomes among Hong Kong Chinese older women.
详细描述
The study will be a randomized controlled trial (RCT) with two groups and three times repeated measures. Data will be collected in a pretest, post-test, and six months after the intervention. The eligible participants will be randomly distributed into one of two groups in a ratio of 1:1. The participants recruited and meeting the screening criteria will receive a 24-week HIIT intervention or recreation workshop. The intervention effects will be evaluated on bone mineral density, bone turnover markers, physical fitness, fear of falling, and quality of life.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• 60 to 74 years at the start date of the project
- •diagnosed with osteopenia by DXA scan screening with a BMD at the femoral neck or total hip or lumbar spine between -1 and -2.5 SD T-score below the average values
- •Passing the PAR-Q plus screening or with the physician's approval for readiness to participate in high-intensity exercise
- •Above the average level of 2-mins stepping showing competent aerobic fitness
- •No restriction on physical mobility
- •No cognitive impairment, as determined by the Chinese version of the Mini-Mental Status Examination (i.e., score < 24)
- •No previous substantial experiences in practicing HIIT. The written informed consent form will be collected from each participant
排除标准
- •• Severe chronic disease restricting high-intensity exercise
- •Having cognition impairment regarded by specialists
- •checked through medical records at HA Go app platform in the past 6 months, have concurrent medical conditions (e.g., thyrotoxicosis or hyperparathyroidism, Paget's disease, renal disease, diabetes, knee or hip osteoarthritis) and use medications (e.g., corticosteroids, estrogen, thyroxine, thiazide diuretics, or antiretroviral agents) known to affect bone metabolism during past 2 years
- •any condition with osteoporosis, osteoporotic fractures
- •current smoker
- •alcohol 3 or more units per day.
研究组 & 干预措施
High-intensity interval training (HIIT)
HIIT program for 24 weeks with a frequency of 2 times per week.
干预措施: HIIT program for 24 weeks with a frequency of 2 times per week. (Behavioral)
Non-exercise control
Participants will not receive any exercise training but will attend 48 recreation workshops.
干预措施: Non-exercise control (Behavioral)
结局指标
主要结局
Bone mineral density
时间窗: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
Bone mineral density at the non-dominant lumbar spine and femoral neck of hip will be measured by one registered technician using DXA (XR-46, Norland, Wisconsin, USA) at an assessment center in the Chinese University of Hong Kong.
Bone turnover markers
时间窗: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).
The two bone turnover markers, P1NP (ng/ml) and CTX (ng/L) will be used to assess the subjects' bone formation and bone resorption. Participants must arrive at the elderly center between 08:30 and 09:30 a.m. after a 12-hour overnight fast and avoid intense physical activity the night before. A qualified nurse will collect 5 mL of venous blood from the antecubital vein, which will coagulate at room temperature for 20-30 minutes before being transported to the lab within one hour. The blood will then be centrifuged at 4 °C and 3000 rpm for 50 minutes, with the resulting sample stored at -80 °C for serum biochemical marker assays. Serum P1NP and CTX levels will be measured using ELISA kits from Immunodiagnostic Systems Inc., and analysis will be conducted by the Hong Kong Polytechnic University test lab.
次要结局
- Physical fitness_Body mass index(Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).)
- Physical fitness_Lower limb muscle strength(Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).)
- Physcal fitness_Upper limb muscle strength(Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test))
- Physical fitness_Aerobic endurance(Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).)
- Physical fitness_Lower body flexibility(Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).)
- Physical fitness_Upper body flexibility(Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).)
- Physical fitness_Mobility and dynamic balance(Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).)
- Fear of falling(Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).)
- Perceived quality of life(Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 24-weeks intervention (T2 post-test), and 6 months after intervention completion (T3 follow-up test).)