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

NCT04281264 | Completed

• 1 other identifier: IB18010
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging Well

Keywords

bone mineral density; healthy aging; resistance training; normobaric hypoxia; cardiovascular health

Outcome Measures

Primary Outcomes (26)

• Change from Baseline Life Quality at 24 weeks

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

  Through study completion, an average of 24 weeks

• Change from Baseline Risk of Fall at 24 weeks

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

  Through study completion, an average of 24 weeks

• Change from Baseline Blood Pressure at 24 weeks

  Blood pressure (mmHg) will be measured with sphygmomanometer

  Through study completion, an average of 24 weeks

• Change from Baseline Cardiovascular Evaluation at 24 weeks

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

  Through study completion, an average of 24 weeks

• 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

  Through study completion, an average of 24 weeks

• Change from Baseline Weight at 24 weeks

  Weight (kilograms) will measure following standard procedures

  Through study completion, an average of 24 weeks

• Change from Baseline Height at 24 weeks

  Height (meters) will measure following standard procedures

  Through study completion, an average of 24 weeks

• 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

  Through study completion, an average of 24 weeks

• Change from Baseline Waist-Hip Ratio at 24 weeks

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

  Through study completion, an average of 24 weeks

• 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).

  Through study completion, an average of 24 weeks

• 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)

  Through study completion, an average of 24 weeks

• 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)

  Through study completion, an average of 24 weeks

• 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)

  Through study completion, an average of 24 weeks

• 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)

  Through study completion, an average of 24 weeks

• 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.

  Through study completion, an average of 24 weeks

• 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.

  Through study completion, an average of 24 weeks

• Change from Baseline Endothelial Markers at 24 weeks

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

  Through study completion, an average of 24 weeks

• 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)

  Through study completion, an average of 24 weeks

• 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)

  Through study completion, an average of 24 weeks

• 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)

  Through study completion, an average of 24 weeks

• 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)

  Through study completion, an average of 24 weeks

• 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)

  Through study completion, an average of 24 weeks

• 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).

  Through study completion, an average of 24 weeks

• Change from Baseline Core muscle strength at 24 weeks

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

  Through study completion, an average of 24 weeks

• Change from Baseline Grip strength at 24 weeks

  Grip strength will be tested using an Handgrip (kilograms)

  Through study completion, an average of 24 weeks

• Change from Baseline Balance at 24 weeks

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

  Through study completion, an average of 24 weeks

Secondary Outcomes (3)

• Socio-Demographic Data

  Baseline

• Change from Baseline Calcium Intake at 24 weeks

  Through study completion, an average of 24 weeks

• Change from Baseline Physical Activity Level at 24 weeks

  Through study completion, an average of 24 weeks

Study Arms (6)

NorCON

NO INTERVENTION

Normoxia Control Group

HypCON

ACTIVE COMPARATOR

Hypoxia Control Group

Behavioral: Passive Hypoxia

NorCIR

PLACEBO COMPARATOR

Normoxia Circuit Training with Elastic Bands Group

Behavioral: Normoxia Circuit Training with Elastic Bands

HypCIR

EXPERIMENTAL

Hypoxia Circuit Training with Elastic Bands Group

Behavioral: Hypoxia Circuit Training with Elastic Bands

NorVIB

PLACEBO COMPARATOR

Normoxia Whole-body Vibration Training Group

Behavioral: Normoxia Vibration

HypVIB

EXPERIMENTAL

Hypoxia Whole-body Vibration Training Group

Behavioral: Hypoxia Vibration

Interventions

Passive Hypoxia BEHAVIORAL

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)

HypCON

Normoxia Circuit Training with Elastic Bands BEHAVIORAL

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)

NorCIR

Hypoxia Circuit Training with Elastic Bands BEHAVIORAL

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)

HypCIR

Normoxia Vibration BEHAVIORAL

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)

NorVIB

Hypoxia Vibration BEHAVIORAL

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)

HypVIB

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Extremadura: lead

Study Sites (1)

Sport Science Faculty. University of Extremadura

Cáceres, 10004, Spain

Location

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  PMID: 22290242 BACKGROUND

• Timon R, Gonzalez-Custodio A, Gusi N, Olcina G. Effects of intermittent hypoxia and whole-body vibration training on health-related outcomes in older adults. Aging Clin Exp Res. 2024 Jan 27;36(1):6. doi: 10.1007/s40520-023-02655-w.

  PMID: 38280022 DERIVED

• Camacho-Cardenosa A, Camacho-Cardenosa M, Martinez-Guardado I, Leal A, Andrada JMV, Timon R. Resistance circuit training combined with hypoxia stimulates bone system of older adults: A randomized trial. Exp Gerontol. 2022 Nov;169:111983. doi: 10.1016/j.exger.2022.111983. Epub 2022 Oct 13.

  PMID: 36243220 DERIVED

• Timon R, Camacho-Cardenosa M, Gonzalez-Custodio A, Olcina G, Gusi N, Camacho-Cardenosa A. Effect of hypoxic conditioning on functional fitness, balance and fear of falling in healthy older adults: a randomized controlled trial. Eur Rev Aging Phys Act. 2021 Dec 1;18(1):25. doi: 10.1186/s11556-021-00279-5.

  PMID: 34852758 DERIVED

• Timon R, Martinez-Guardado I, Camacho-Cardenosa A, Villa-Andrada JM, Olcina G, Camacho-Cardenosa M. Effect of intermittent hypoxic conditioning on inflammatory biomarkers in older adults. Exp Gerontol. 2021 Sep;152:111478. doi: 10.1016/j.exger.2021.111478. Epub 2021 Jul 10.

  PMID: 34256114 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of research group GAEDAF

Model Details: Randomized control trial, in which the experimental sample will be divided into 6 groups where different intervention programs will be performed

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 24, 2020
• Study Start: February 9, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)