Strength Training in Hypoxia to Improve Bone and Cardiovascular Health of Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from Baseline Life Quality at 24 weeks
研究概览
简要总结
Due to age-related effects, the bone and cardiovascular health are damaged. Physical exercise and in particular the strength training has been proposed as a fundamental tool to these pathologies, especially in the elderly. On the other hand, the use of normobaric hypoxia combined with exercise could have a beneficial synergistic effect on disease prevention and the quality of life of the elderly.
Therefore, the general objective of this project is to analyze the effects of different methods of strength training combined with conditions of normobaric hypoxia on the bone and cardiovascular health of the elderly. This general objective is specified in the following specific objectives:
- To analyze the effects of circuit training with elastic bands on bone mineral density and bone remodelling markers of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of circuit training with elastic bands on biochemical parameters, inflammatory, endothelial and clinical markers just like cardiovascular risk level of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of circuit training with elastic bands on body composition and functional capacity of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of whole-body vibration training on bone mineral density and bone remodelling markers of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of whole-body vibration training on biochemical parameters, inflammatory, endothelial and clinical markers just like cardiovascular risk level of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of whole-body vibration training on body composition and functional capacity of elderly, under normoxic and normobaric hypoxic conditions.
- To compare the effects of circuit training with elastic bands versus whole-body vibration training on bone and cardiovascular health of elderly, under normoxic and normobaric hypoxic conditions.
- To value the normobaric hypoxic environment efficacy on bone and cardiovascular health of elderly subjected to circuit training with elastic bands and whole-body vibration training.
We hypothesize that bone and cardiovascular health will improve in the participants subjected to both resistance training, but greater improved may be found when these protocol are combined with normobaric hypoxia.
详细描述
Participants:
Various associations of pensioners will be contacted as well as the university of seniors of the University of Extremadura to recruit volunteer participants. Total sample size will be 120 people, being this calculated to obtaining a statistical power of 90%, calculated with a margin of error of 5% and a mean difference of 10% in the study variables Design All interventions will be performed during 24 weeks, with a frequency training of 3 days per weeks; sessions will be scheduled with at least one day of rest in between for optimal recovery. All patients were assessed at two time points: at baseline before intervention (Pre) and reassessed 7 days after the last session (Post). Participants will be instructed to continue with their normal daily activities, diet and caloric and calcium intake for the entire duration of the study.
Interventions:
During several times of the session in each intervention, oxygen saturation (SpO2) will be controlled using a finger pulse-oximeter (Konica Minolta, Japan) and heart rate (HR) using a heart rate monitor (Polar team 2, Polar, Finland) to know the physiological challenge posed on the participants during the exposure.
PASSIVE HYPOXIA:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •women and men aged 65 years or older
- •no current medical condition not compatible with planned exercise
- •free of illness or medication potentially affecting the bone and cardiovascular system
- •estimated daily calcium intake of 1200-2000 mg/day
- •consumption of no more than two alcoholic beverages per day.
排除标准
- •participation in any other type of intervention based on physical exercise in the last 6 months in order to avoid interactions with the previous practice
- •subjects have been above 1500 m during the last 3 months
- •contra indications for whole-body vibration training: severe cardiovascular diseases, ocular diseases that affect the retina, neuromuscular and heart diseases, stroke, implant, bypass, stent, arthritis and other joint disease or epilepsy
研究组 & 干预措施
NorCON
Normoxia Control Group
HypCON
Hypoxia Control Group
干预措施: Passive Hypoxia (Behavioral)
NorCIR
Normoxia Circuit Training with Elastic Bands Group
干预措施: Normoxia Circuit Training with Elastic Bands (Behavioral)
HypCIR
Hypoxia Circuit Training with Elastic Bands Group
干预措施: Hypoxia Circuit Training with Elastic Bands (Behavioral)
NorVIB
Normoxia Whole-body Vibration Training Group
干预措施: Normoxia Vibration (Behavioral)
HypVIB
Hypoxia Whole-body Vibration Training Group
干预措施: Hypoxia Vibration (Behavioral)
结局指标
主要结局
Change from Baseline Life Quality at 24 weeks
时间窗: Through study completion, an average of 24 weeks
SF-36 questionnaire will be used to know the life quality
Change from Baseline Risk of Fall at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Risk of fall will be evaluated through Fall Efficacy Scale-International (FES-I)
Change from Baseline Blood Pressure at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Blood pressure (mmHg) will be measured with sphygmomanometer
Change from Baseline Cardiovascular Evaluation at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Arm-ankle index and pulse wave velocity will be measured using ultrasound Doppler technique
Change from Baseline Cardiovascular Risk at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Based on the following factors: age, sex, smoking, total cholesterol, HDL cholesterol, systolic blood pressure and diabetes, cardiovascular risk will be determined. This method was already described in the FRESCO study
Change from Baseline Weight at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Weight (kilograms) will measure following standard procedures
Change from Baseline Height at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Height (meters) will measure following standard procedures
Change from Baseline Body Mass Index at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Weight and Height will be combined to report body mass index (BMI) in kg/m\^2
Change from Baseline Waist-Hip Ratio at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Waist and hip diameter (centimeters) will be combined to report Waist-Hip Ratio
Change from Baseline Body Composition at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Body composition variables such as percentage fat and lean fat mass (percentage) will be obtain using dual-energy X-ray absorptiometry (DXA,Norland Excell Plus; Norland Inc., Fort Atkinson, United States).
Change from Baseline Bone Mineral Density at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Bone mineral density (g/cm-2) of whole body and proximal femur region will be calculated from obtained data of dual-energy X-ray absorptiometry (DXA,Norland Excell Plus; Norland Inc., Fort Atkinson, United States)
Change from Baseline Osteoporosis/Osteopenia Prevalence at 24 weeks
时间窗: Through study completion, an average of 24 weeks
T-score of whole body and proximal femur region will be calculated from obtained data of dual-energy X-ray absorptiometry (DXA,Norland Excell Plus; Norland Inc., Fort Atkinson, United States)
Change from Baseline Bone Mineral Content at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Bone mineral content (g) of whole body and proximal femur region will be calculated from obtained data of dual-energy X-ray absorptiometry (DXA,Norland Excell Plus; Norland Inc., Fort Atkinson, United States)
Change from Baseline Biochemical Parameters at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Standard biochemical analysis (HDL, LDL and Total Cholesterol, Triglycerides and Glucose in mg/dL) will be obtained of blood samples, through a clinical chemistry analyzer (Spotchem, Arkray Factory, Germany)
Change from Baseline Bone Remodelling Markers at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Bone remodelling (VEGF and SDF-1 in mg/dL) markers will be analyzed by ELISA technique.
Change from Baseline Inflammatory Markers at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Inflammatory (C-reactive protein, IL-2, IL-4, IL-6 and TNFa in mg/dL) markers will be analyzed by ELISA technique.
Change from Baseline Endothelial Markers at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Endothelial (ICAM-1 and VCAM-1 in mg/dL) markers will be analyzed by ELISA technique.
Change from Baseline Lower Limb Strength at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Lower limb strength will be tested by Chair stand Test (repetitions)
Change from Baseline Upper Limb Strength at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Upper limb strength will be tested by Arm curl Test (repetitions)
Change from Baseline Lower Limb Flexibility at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Lower limb flexibility will be tested by Chair sit and reach Test (centimeters)
Change from Baseline Upper Limb Flexibility at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Upper limb flexibility will be tested by Back scratch Test (centimeters)
Change from Baseline Endurance at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Endurance will be tested by 6 min. walk Test (meters)
Change from Baseline Agility at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Agility will be tested by 8ft Up and Go Test (seconds).
Change from Baseline Core muscle strength at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Core muscle strength will be tested by plank test (seconds)
Change from Baseline Grip strength at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Grip strength will be tested using an Handgrip (kilograms)
Change from Baseline Balance at 24 weeks
时间窗: Through study completion, an average of 24 weeks
Balance will be tested by single leg stance test (seconds)
次要结局
- Change from Baseline Calcium Intake at 24 weeks(Through study completion, an average of 24 weeks)
- Socio-Demographic Data(Baseline)
- Change from Baseline Physical Activity Level at 24 weeks(Through study completion, an average of 24 weeks)
研究者
Rafael Timón, PhD
Head of research group GAEDAF
University of Extremadura