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Strength Training in Hypoxia to Improve Bone and Cardiovascular Health of Elderly

Primary Purpose

Aging Well

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Passive Hypoxia
Normoxia Circuit Training with Elastic Bands
Hypoxia Circuit Training with Elastic Bands
Normoxia Vibration
Hypoxia Vibration
Sponsored by
University of Extremadura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aging Well focused on measuring bone mineral density, healthy aging, resistance training, normobaric hypoxia, cardiovascular health

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. women and men aged 65 years or older
  2. no current medical condition not compatible with planned exercise
  3. free of illness or medication potentially affecting the bone and cardiovascular system
  4. estimated daily calcium intake of 1200-2000 mg/day
  5. consumption of no more than two alcoholic beverages per day.

Exclusion Criteria:

  1. 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
  2. subjects have been above 1500 m during the last 3 months
  3. 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

Sites / Locations

  • Sport Science Faculty. University of Extremadura

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

Active Comparator

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

NorCON

HypCON

NorCIR

HypCIR

NorVIB

HypVIB

Arm Description

Normoxia Control Group

Hypoxia Control Group

Normoxia Circuit Training with Elastic Bands Group

Hypoxia Circuit Training with Elastic Bands Group

Normoxia Whole-body Vibration Training Group

Hypoxia Whole-body Vibration Training Group

Outcomes

Primary Outcome Measures

Change from Baseline Life Quality at 24 weeks
SF-36 questionnaire will be used to know the life quality
Change from Baseline Risk of Fall at 24 weeks
Risk of fall will be evaluated through Fall Efficacy Scale-International (FES-I)
Change from Baseline Blood Pressure at 24 weeks
Blood pressure (mmHg) will be measured with sphygmomanometer
Change from Baseline Cardiovascular Evaluation at 24 weeks
Arm-ankle index and pulse wave velocity will be measured using ultrasound Doppler technique
Change from Baseline Cardiovascular Risk at 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
Weight (kilograms) will measure following standard procedures
Change from Baseline Height at 24 weeks
Height (meters) will measure following standard procedures
Change from Baseline Body Mass Index at 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
Waist and hip diameter (centimeters) will be combined to report Waist-Hip Ratio
Change from Baseline Body Composition at 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
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
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
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
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
Bone remodelling (VEGF and SDF-1 in mg/dL) markers will be analyzed by ELISA technique.
Change from Baseline Inflammatory Markers at 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
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
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
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
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
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
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
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
Core muscle strength will be tested by plank test (seconds)
Change from Baseline Grip strength at 24 weeks
Grip strength will be tested using an Handgrip (kilograms)
Change from Baseline Balance at 24 weeks
Balance will be tested by single leg stance test (seconds)

Secondary Outcome Measures

Socio-Demographic Data
A general questionnaire was administered to collect medical and demographic data to check the inclusion/exclusion criteria.
Change from Baseline Calcium Intake at 24 weeks
Calcium intake (mg/day) will be estimated using a food frequency questionnaire
Change from Baseline Physical Activity Level at 24 weeks
The bone-specific physical activity questionnaire (B-PAQ; score) will be used to assess the physical activity level of the participants.

Full Information

First Posted
February 14, 2020
Last Updated
July 6, 2021
Sponsor
University of Extremadura
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1. Study Identification

Unique Protocol Identification Number
NCT04281264
Brief Title
Strength Training in Hypoxia to Improve Bone and Cardiovascular Health of Elderly
Official Title
Strength Training in Hypoxia to Improve Bone and Cardiovascular Health of Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 9, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Extremadura

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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: During 30 minutes of session, the participants will be performed an intellectual activity while they will be exposed to normobaric hypoxic conditions in a hypoxic chamber (CAT 310, Lousiville, Colorado). They will inspire oxygen fraction (FiO2) set to 16.1% (0.16) in order to simulate an altitude of 2500m above sea level. NORMOXIA CIRCUIT TRAINING WITH ELASTIC BANDS Each training sessions will consist of a circuit training, where different muscle groups will be involved (pectoral, shoulders, back, arms, thighs, legs and abdominals). Duration of the session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the sessions. Main section of the sessions will be a circuit that will be composed by 3 sets of 12-15 repetitions of nine different exercises. Six exercises will be performed using elastic resistance bands (ERS; TheraBand®): chest press, row, glute kickbacks, front and side raises, standing bíceps curls and triceps kickbacks. To provide resistance with ERB, elastic bands with resistance ranging from light to very heavy loading (colors: yellow-gold) were used. ERBs were 2 meters, but the actual length used (grip on ERBs and distance to anchor point) was fine tuned for each subject in each exercise to find the correct resistance. When necessary to increase loading, two or more bands were combined. Bands were prestretched and never elongated more than 300% of resting length, as recommended by the manufacturer. Two additional exercise will be developed with kettlebell (KB): squat with 6 kg or increase loading until 10 kg; and hip trust, increase loading with support of a foot alone or with additional loading (KB of 5 or 10 kg). Finally, the subjects will keep a plank position during 15-20 seconds. Training will take place in a hypoxia chamber (CAT 310, Lousiville, Colorado, United States) will place in the laboratory. In order to blind subjects to altitude, the system will be run with normoxic airflow into the chamber (up to 1000 l/min) and will produce the same audible noise as in the hypoxic condition. Subjects will inspire FiO2 of 21.0% (0.21) to simulate an altitude of 459 m above sea level. Furthermore, all systems will be covered with fabric to prevent participants from visually identifying the normoxic or hypoxic conditions. FiO2 will be controlled regularly with an electronic device (HANDIC,Maxtec, Salt Lake City, Utah, United States). HYPOXIA CIRCUIT TRAINING WITH ELASTIC BANDS Each training sessions will consist of a circuit training, where different muscle groups will be involved (pectoral, shoulders, back, arms, thighs, legs and abdominals). Duration of the session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the sessions. Main section of the sessions will be a circuit, that will be composed by 3 sets of 12-15 repetitions of nine different exercises. Six exercises will be performed using elastic resistance bands (ERS; TheraBand®): chest press, row, glute kickbacks, front and side raises, standing bíceps curls and triceps kickbacks. To provide resistance with ERB, elastic bands with resistance ranging from light to very heavy loading (colors: yellow-gold) were used. ERBs were 2 meters, but the actual length used (grip on ERBs and distance to anchor point) was fine tuned for each subject in each exercise to find the correct resistance. When necessary to increase loading, two or more bands were combined. Bands were prestretched and never elongated more than 300% of resting length, as recommended by the manufacturer. Two additional exercise will be developed with kettlebell (KB): squat with 6 kg or increase loading until 10 kg; and hip trust, increase loading with support of a foot alone or with additional loading (KB of 5 or 10 kg). Finally, the subjects will keep a plank position during 15-20 seconds Training will take place in a hypoxia chamber (CAT 310, Lousiville, Colorado, United States) will place in the laboratory. Participants will inspire a fraction of inspired oxygen (FiO2) of 16.1% (0.16) to simulate an altitude of 2500 m above sea level; FiO2 will be controlled regularly with an electronic device (HANDIC,Maxtec, Salt Lake City, Utah, United States). NORMOXIA WHOLE-BODY VIBRATION The subjects will perform dynamic and static vibration exercise provide by a commercially available device (Galileo 2000, Novotec GmbH, Pforzheim, Alemania). The duration of the WBV session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the session. Repetitions of 30 seconds with a frequency of 18.5 Hz will be performed. The rest interval will be 60 seconds between 4 repetitions during weeks 1-12 and 45 seconds between 5 repetitions during weeks 12-24. The vertical amplitude of WBV was set at 2.5 mm. Four stance will be performance, with the soles of both feet remained in contact with the platform: Stand with feet side-by-side on the board, which produced lateral oscillations of the whole body. During the vibration training sessions, the subjects will be barefoot to eliminate any damping of the vibration caused by footwear. The angle of flexion of the knees during the vibration exercise will be set at 60°. Begin with the feet placed perpendicular to the midline axis of the platform, with a foot positioned slightly ahead of the other foot. Lift the toes of the one foot and the heel of the other foot 4 mm above the surface of the platform. Bend the knees and maintain a 45°knee angle. Keep the back and head straight. Alternate legs. Front foot 4 mm above the surface of the platform and back foot on ground, front knee angle 90°. Alternate legs Lay down on the ground, with the knees bent and feet flat on the platform. Keep the arms at your side with your palms down. Lift the hips off the ground until the knees, hips and shoulders form a straight line. Hold your bridged position. Training will take place in a hypoxia chamber (CAT 310, Lousiville, Colorado, United States) will place in the laboratory. In order to blind subjects to altitude, the system will be run with normoxic airflow into the chamber (up to 1000 l/min) and will produce the same audible noise as in the hypoxic condition. Subjects will inspire FiO2 of 21.0% (0.21) to simulate an altitude of 459 m above sea level. Furthermore, all systems will be covered with fabric to prevent participants from visually identifying the normoxic or hypoxic conditions. FiO2 will be controlled regularly with an electronic device (HANDIC,Maxtec, Salt Lake City, Utah, United States). HYPOXIA WHOLE-BODY VIBRATION The subjects will perform dynamic and static vibration exercise provide by a commercially available device (Galileo 2000, Novotec GmbH, Pforzheim, Alemania). The duration of the WBV session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the session. Repetitions of 30 seconds with a frequency of 18.5 Hz will be performed. The rest interval will be 60 seconds between 4 repetitions during weeks 1-12 and 45 seconds between 5 repetitions during weeks 12-24. The vertical amplitude of WBV was set at 2.5 mm. Four stance will be performance, with the soles of both feet remained in contact with the platform: Stand with feet side-by-side on the board, which produced lateral oscillations of the whole body. During the vibration training sessions, the subjects will be barefoot to eliminate any damping of the vibration caused by footwear. The angle of flexion of the knees during the vibration exercise will be set at 60°. Begin with the feet placed perpendicular to the midline axis of the platform, with a foot positioned slightly ahead of the other foot. Lift the toes of the one-foot and the heel of the other foot 4 mm above the surface of the platform. Bend the knees and maintain a 45°knee angle. Keep the back and head straight. Alternate legs. Front foot 4 mm above the surface of the platform and back foot on ground, front knee angle 90°. Alternate legs Lay down on the ground, with the knees bent and feet flat on the platform. Keep the arms at your side with your palms down. Lift the hips off the ground until the knees, hips and shoulders form a straight line. Hold your bridged position. Training will take place in a hypoxia chamber (CAT 310, Lousiville, Colorado, United States) will place in the laboratory. Participants will inspire a fraction of inspired oxygen (FiO2) of 16.1% (0.16) to simulate an altitude of 2500 m above sea level; FiO2 will be controlled regularly with an electronic device (HANDIC,Maxtec, Salt Lake City, Utah, United States). Statistical Analysis Statistical analyses will be performed using the statistical analysis package SPSS v.20 (IBM, New York, United States). Data will be expressed as median and standard deviation. Kolmogorov-Smirnov tests will be conducted to show the distribution of the studied variables and Levene's test for homogeneity of variance. Repeated measure ANOVA will be used to compare the response of each variable, considering the sex and age as covariate. The p < 0.05 criterion was used for establishing statistical significance. Effect size (Cohen, 1992) will be also calculated for all variables, considering the magnitude of change as small (0.2), moderate (0.5) or large (0.8).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging Well
Keywords
bone mineral density, healthy aging, resistance training, normobaric hypoxia, cardiovascular health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Randomized control trial, in which the experimental sample will be divided into 6 groups where different intervention programs will be performed
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NorCON
Arm Type
No Intervention
Arm Description
Normoxia Control Group
Arm Title
HypCON
Arm Type
Active Comparator
Arm Description
Hypoxia Control Group
Arm Title
NorCIR
Arm Type
Placebo Comparator
Arm Description
Normoxia Circuit Training with Elastic Bands Group
Arm Title
HypCIR
Arm Type
Experimental
Arm Description
Hypoxia Circuit Training with Elastic Bands Group
Arm Title
NorVIB
Arm Type
Placebo Comparator
Arm Description
Normoxia Whole-body Vibration Training Group
Arm Title
HypVIB
Arm Type
Experimental
Arm Description
Hypoxia Whole-body Vibration Training Group
Intervention Type
Behavioral
Intervention Name(s)
Passive Hypoxia
Intervention Description
During 30 minutes of session, the participants will perform an intellectual activity while they will be exposed to normobaric hypoxic conditions in a hypoxic chamber (CAT 310, Lousiville, Colorado). They will inspire oxygen fraction (FiO2) set to 16.1% (0.16)
Intervention Type
Behavioral
Intervention Name(s)
Normoxia Circuit Training with Elastic Bands
Intervention Description
Each training sessions will consist of a circuit training with elastic bands, where different muscle groups will be involved (pectoral, shoulders, back, arms, thighs, legs and abdominals). Duration of the session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the sessions. Main section of the sessions will be a circuit that will be composed by 3 sets of 12-15 repetitions of nine different exercises. Subjects will inspire FiO2 of 21.0% (0.21)
Intervention Type
Behavioral
Intervention Name(s)
Hypoxia Circuit Training with Elastic Bands
Intervention Description
Each training sessions will consist of a circuit training with elastic bands, where different muscle groups will be involved (pectoral, shoulders, back, arms, thighs, legs and abdominals). Duration of the session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the sessions. Main section of the sessions will be a circuit that will be composed by 3 sets of 12-15 repetitions of nine different exercises. Subjects will inspire FiO2 of 21.0% (0.21)
Intervention Type
Behavioral
Intervention Name(s)
Normoxia Vibration
Intervention Description
The subjects will perform dynamic and static vibration exercise provide by a commercially available device (Galileo 2000, Novotec GmbH, Pforzheim, Alemania). The duration of the WBV session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles. Repetitions of 30 seconds with a frequency of 18.5 Hz will be performed. The rest interval will be 60 seconds between 4 repetitions during weeks 1-12 and 45 seconds between 5 repetitions during weeks 12-24. The vertical amplitude of WBV was set at 2.5 mm. Four stance will be performed on platform. Subjects will inspire FiO2 of 21.0% (0.21)
Intervention Type
Behavioral
Intervention Name(s)
Hypoxia Vibration
Intervention Description
The subjects will perform dynamic and static vibration exercise provide by a commercially available device (Galileo 2000, Novotec GmbH, Pforzheim, Alemania). The duration of the WBV session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles. Repetitions of 30 seconds with a frequency of 18.5 Hz will be performed. The rest interval will be 60 seconds between 4 repetitions during weeks 1-12 and 45 seconds between 5 repetitions during weeks 12-24. The vertical amplitude of WBV was set at 2.5 mm. Four stance will be performance on the platform. Participants will inspire a fraction of inspired oxygen (FiO2) of 16.1% (0.16)
Primary Outcome Measure Information:
Title
Change from Baseline Life Quality at 24 weeks
Description
SF-36 questionnaire will be used to know the life quality
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Risk of Fall at 24 weeks
Description
Risk of fall will be evaluated through Fall Efficacy Scale-International (FES-I)
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Blood Pressure at 24 weeks
Description
Blood pressure (mmHg) will be measured with sphygmomanometer
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Cardiovascular Evaluation at 24 weeks
Description
Arm-ankle index and pulse wave velocity will be measured using ultrasound Doppler technique
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Cardiovascular Risk at 24 weeks
Description
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
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Weight at 24 weeks
Description
Weight (kilograms) will measure following standard procedures
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Height at 24 weeks
Description
Height (meters) will measure following standard procedures
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Body Mass Index at 24 weeks
Description
Weight and Height will be combined to report body mass index (BMI) in kg/m^2
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Waist-Hip Ratio at 24 weeks
Description
Waist and hip diameter (centimeters) will be combined to report Waist-Hip Ratio
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Body Composition at 24 weeks
Description
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).
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Bone Mineral Density at 24 weeks
Description
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)
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Osteoporosis/Osteopenia Prevalence at 24 weeks
Description
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)
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Bone Mineral Content at 24 weeks
Description
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)
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Biochemical Parameters at 24 weeks
Description
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)
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Bone Remodelling Markers at 24 weeks
Description
Bone remodelling (VEGF and SDF-1 in mg/dL) markers will be analyzed by ELISA technique.
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Inflammatory Markers at 24 weeks
Description
Inflammatory (C-reactive protein, IL-2, IL-4, IL-6 and TNFa in mg/dL) markers will be analyzed by ELISA technique.
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Endothelial Markers at 24 weeks
Description
Endothelial (ICAM-1 and VCAM-1 in mg/dL) markers will be analyzed by ELISA technique.
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Lower Limb Strength at 24 weeks
Description
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)
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Upper Limb Strength at 24 weeks
Description
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)
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Lower Limb Flexibility at 24 weeks
Description
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)
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Upper Limb Flexibility at 24 weeks
Description
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)
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Endurance at 24 weeks
Description
Senior Fitness Test battery will be used to know of physical condition of elderly. Endurance will be tested by 6 min. walk Test (meters)
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Agility at 24 weeks
Description
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).
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Core muscle strength at 24 weeks
Description
Core muscle strength will be tested by plank test (seconds)
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Grip strength at 24 weeks
Description
Grip strength will be tested using an Handgrip (kilograms)
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Balance at 24 weeks
Description
Balance will be tested by single leg stance test (seconds)
Time Frame
Through study completion, an average of 24 weeks
Secondary Outcome Measure Information:
Title
Socio-Demographic Data
Description
A general questionnaire was administered to collect medical and demographic data to check the inclusion/exclusion criteria.
Time Frame
Baseline
Title
Change from Baseline Calcium Intake at 24 weeks
Description
Calcium intake (mg/day) will be estimated using a food frequency questionnaire
Time Frame
Through study completion, an average of 24 weeks
Title
Change from Baseline Physical Activity Level at 24 weeks
Description
The bone-specific physical activity questionnaire (B-PAQ; score) will be used to assess the physical activity level of the participants.
Time Frame
Through study completion, an average of 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Sport Science Faculty. University of Extremadura
City
Cáceres
ZIP/Postal Code
10004
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25236519
Citation
Bhella PS, Hastings JL, Fujimoto N, Shibata S, Carrick-Ranson G, Palmer MD, Boyd KN, Adams-Huet B, Levine BD. Impact of lifelong exercise "dose" on left ventricular compliance and distensibility. J Am Coll Cardiol. 2014 Sep 23;64(12):1257-66. doi: 10.1016/j.jacc.2014.03.062.
Results Reference
background
PubMed Identifier
19190316
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Strength Training in Hypoxia to Improve Bone and Cardiovascular Health of Elderly

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