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

• Sponsor: University of Extremadura (Other)
• Overall Status: Completed
• CT.gov ID: NCT04281264
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 6
• Actual Duration (Months): 28.6
• Patients Per Site Per Month: 4.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aging Well	Behavioral: Passive Hypoxia; Behavioral: Normoxia Circuit Training with Elastic Bands; Behavioral: Hypoxia Circuit Training with Elastic Bands; Behavioral: Normoxia Vibration; Behavioral: Hypoxia Vibration	N/A

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:

1. 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°.

2. 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.

3. Front foot 4 mm above the surface of the platform and back foot on ground, front knee angle 90°. Alternate legs

4. 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:

1. 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°.

2. 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.

3. Front foot 4 mm above the surface of the platform and back foot on ground, front knee angle 90°. Alternate legs

4. 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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: Randomized control trial, in which the experimental sample will be divided into 6 groups where different intervention programs will be performedRandomized control trial, in which the experimental sample will be divided into 6 groups where different intervention programs will be performed
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Strength Training in Hypoxia to Improve Bone and Cardiovascular Health of Elderly
• Actual Study Start Date: Feb 9, 2019
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: NorCON Normoxia Control Group
Active Comparator: HypCON Hypoxia Control Group	Behavioral: Passive Hypoxia; 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)
Placebo Comparator: NorCIR Normoxia Circuit Training with Elastic Bands Group	Behavioral: Normoxia Circuit Training with Elastic Bands; 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)
Experimental: HypCIR Hypoxia Circuit Training with Elastic Bands Group	Behavioral: Hypoxia Circuit Training with Elastic Bands; 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)
Placebo Comparator: NorVIB Normoxia Whole-body Vibration Training Group	Behavioral: Normoxia 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. 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)
Experimental: HypVIB Hypoxia Whole-body Vibration Training Group	Behavioral: Hypoxia 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. 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)

Outcome Measures

Primary Outcome Measures

1. Change from Baseline Life Quality at 24 weeks [Through study completion, an average of 24 weeks]

   SF-36 questionnaire will be used to know the life quality

2. Change from Baseline Risk of Fall at 24 weeks [Through study completion, an average of 24 weeks]

   Risk of fall will be evaluated through Fall Efficacy Scale-International (FES-I)

3. Change from Baseline Blood Pressure at 24 weeks [Through study completion, an average of 24 weeks]

   Blood pressure (mmHg) will be measured with sphygmomanometer

4. Change from Baseline Cardiovascular Evaluation at 24 weeks [Through study completion, an average of 24 weeks]

   Arm-ankle index and pulse wave velocity will be measured using ultrasound Doppler technique

5. Change from Baseline Cardiovascular Risk at 24 weeks [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

6. Change from Baseline Weight at 24 weeks [Through study completion, an average of 24 weeks]

   Weight (kilograms) will measure following standard procedures

7. Change from Baseline Height at 24 weeks [Through study completion, an average of 24 weeks]

   Height (meters) will measure following standard procedures

8. Change from Baseline Body Mass Index at 24 weeks [Through study completion, an average of 24 weeks]

   Weight and Height will be combined to report body mass index (BMI) in kg/m^2

9. Change from Baseline Waist-Hip Ratio at 24 weeks [Through study completion, an average of 24 weeks]

   Waist and hip diameter (centimeters) will be combined to report Waist-Hip Ratio

10. Change from Baseline Body Composition at 24 weeks [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).

11. Change from Baseline Bone Mineral Density at 24 weeks [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)

12. Change from Baseline Osteoporosis/Osteopenia Prevalence at 24 weeks [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)

13. Change from Baseline Bone Mineral Content at 24 weeks [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)

14. Change from Baseline Biochemical Parameters at 24 weeks [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)

15. Change from Baseline Bone Remodelling Markers at 24 weeks [Through study completion, an average of 24 weeks]

    Bone remodelling (VEGF and SDF-1 in mg/dL) markers will be analyzed by ELISA technique.

16. Change from Baseline Inflammatory Markers at 24 weeks [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.

17. Change from Baseline Endothelial Markers at 24 weeks [Through study completion, an average of 24 weeks]

    Endothelial (ICAM-1 and VCAM-1 in mg/dL) markers will be analyzed by ELISA technique.

18. Change from Baseline Lower Limb Strength at 24 weeks [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)

19. Change from Baseline Upper Limb Strength at 24 weeks [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)

20. Change from Baseline Lower Limb Flexibility at 24 weeks [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)

21. Change from Baseline Upper Limb Flexibility at 24 weeks [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)

22. Change from Baseline Endurance at 24 weeks [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)

23. Change from Baseline Agility at 24 weeks [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).

24. Change from Baseline Core muscle strength at 24 weeks [Through study completion, an average of 24 weeks]

    Core muscle strength will be tested by plank test (seconds)

25. Change from Baseline Grip strength at 24 weeks [Through study completion, an average of 24 weeks]

    Grip strength will be tested using an Handgrip (kilograms)

26. Change from Baseline Balance at 24 weeks [Through study completion, an average of 24 weeks]

    Balance will be tested by single leg stance test (seconds)

Secondary Outcome Measures

1. Socio-Demographic Data [Baseline]

   A general questionnaire was administered to collect medical and demographic data to check the inclusion/exclusion criteria.

2. Change from Baseline Calcium Intake at 24 weeks [Through study completion, an average of 24 weeks]

   Calcium intake (mg/day) will be estimated using a food frequency questionnaire

3. Change from Baseline Physical Activity Level at 24 weeks [Through study completion, an average of 24 weeks]

   The bone-specific physical activity questionnaire (B-PAQ; score) will be used to assess the physical activity level of the participants.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sport Science Faculty. University of Extremadura	Cáceres		Spain	10004

Sponsors and Collaborators

• University of Extremadura

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 25, 2019
• Informed Consent Form - Jul 6, 2018

More Information

Publications

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• Responsible Party: Rafael Timón, PhD, Head of research group GAEDAF, University of Extremadura
• ClinicalTrials.gov Identifier: NCT04281264
• Other Study ID Numbers: IB18010
• First Posted: Feb 24, 2020
• Last Update Posted: Jul 7, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rafael Timón, PhD, Head of research group GAEDAF, University of Extremadura: bone mineral density; healthy aging; resistance training; normobaric hypoxia; cardiovascular health
• Additional relevant MeSH terms: Hypoxia

Study Results

No Results Posted as of Jul 7, 2021