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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04281264
Recruitment Status : Active, not recruiting
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Rafael Timón, University of Extremadura

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 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 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 : February 9, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

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)





Primary Outcome Measures :
  1. Change from Baseline Life Quality at 24 weeks [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Through study completion, an average of 24 weeks ]
    Weight (kilograms) will measure following standard procedures

  7. Change from Baseline Height at 24 weeks [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04281264


Locations
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Spain
Sport Science Faculty. University of Extremadura
Cáceres, Spain, 10004
Sponsors and Collaborators
University of Extremadura
  Study Documents (Full-Text)

Documents provided by Rafael Timón, University of Extremadura:
Informed Consent Form  [PDF] July 6, 2018

Publications:
Graham I, Atar D, Borch-Johnsen K, Boysen G, Burell G, Cifkova R, Dallongeville J, De Backer G, Ebrahim S, Gjelsvik B, Herrmann-Lingen C, Hoes A, Humphries S, Knapton M, Perk J, Priori SG, Pyorala K, Reiner Z, Ruilope L, Sans-Menendez S, Op Reimer WS, Weissberg P, Wood D, Yarnell J, Zamorano JL, Walma E, Fitzgerald T, Cooney MT, Dudina A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Funck-Brentano C, Filippatos G, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Altiner A, Bonora E, Durrington PN, Fagard R, Giampaoli S, Hemingway H, Hakansson J, Kjeldsen SE, Larsen mL, Mancia G, Manolis AJ, Orth-Gomer K, Pedersen T, Rayner M, Ryden L, Sammut M, Schneiderman N, Stalenhoef AF, Tokgözoglu L, Wiklund O, Zampelas A; European Society of Cardiology (ESC); European Association for Cardiovascular Prevention and Rehabilitation (EACPR); Council on Cardiovascular Nursing; European Association for Study of Diabetes (EASD); International Diabetes Federation Europe (IDF-Europe); European Stroke Initiative (EUSI); Society of Behavioural Medicine (ISBM); European Society of Hypertension (ESH); WONCA Europe (European Society of General Practice/Family Medicine); European Heart Network (EHN); European Atherosclerosis Society (EAS). European guidelines on cardiovascular disease prevention in clinical practice: full text. Fourth Joint Task Force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of nine societies and by invited experts). Eur J Cardiovasc Prev Rehabil. 2007 Sep;14 Suppl 2:S1-113.

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Responsible Party: Rafael Timón, Head of research group GAEDAF, University of Extremadura
ClinicalTrials.gov Identifier: NCT04281264    
Other Study ID Numbers: IB18010
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rafael Timón, University of Extremadura:
bone mineral density
healthy aging
resistance training
normobaric hypoxia
cardiovascular health
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory