Aging Clinical Trial
Official title:
Effects of Slow-speed Traditional Resistance Training, High-speed Resistance Training and Multicomponent Training With Variable Resistances on Molecular, Body Composition, Neuromuscular, Physical Function and Quality of Life Variables in Older Adults.
Verified date | October 2018 |
Source | University of Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Human aging is characterized by a progressive deterioration of multiple physiologic systems,
with marked decreases in skeletal muscle mass, muscle strength, physical function and quality
of life beginning in the sixth decade in life. These deleterious modifications have a
significant impact upon mobility and ability to undertake daily living activities in elderly
people. If we consider that, according to current projections, the proportion of the European
population over 65 years will increase from 17% in 2010 to 30% in 2060 and that physical
activity participation rates for older adults (>60 years) remain low, with only 16% meeting
the recommendations of the American College of Sports Medicine Guidelines (11% for resistance
training), we need to understand what type of training (strategy) can be the most effective
for reverse physical impairments, and not only that, but which one obtains greater adherence
and self-perception for contribute a healthier, active and more independent elderly
population in the future.
Thus, the purpose of this study is to investigate the effects of 20-week slow-speed
traditional resistance training, high-speed resistance training and multicomponent training
program with variable resistance (elastic bands) on molecular, body composition,
neuromuscular, physical function and quality of life variables in older adults. This research
also aims to evaluate if this novel types of training intervention (using variable
resistances such as elastic bands in all the training programs and measure the intensity with
the OMNI-RES perceived exertion specific for older adults) is feasible in this population,
through analysis of adherence, intervention fidelity and self-perception reported.
Status | Completed |
Enrollment | 192 |
Est. completion date | July 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Age>60 years. - Physically independent (able to walk 100 meters without a walking aid and climb 10 steps without rest). - Medical certificate of suitability or fitness to practice resistance training activities. - No plans to leave the area during the intervention. - Cognitive ability to understand, follow the instructions and sign the informed consent form. - Free of any antioxidant supplements for at least 6 weeks before the start of this study. - Willingness to be randomized to either intervention group and to follow the study protocol. Exclusion Criteria: - Presence of cardiovascular, musculoskeletal, renal, liver or neuromuscular disorders that would prevent the participant from performing the exercises. - Body weight changes >10% in the previous year. - Intake of prescription medications that were expected to alter the results of the study (ergogenic, dietary aids, estrogen, steroid hormones, calcitonin, or corticosteroids). - A history of malignant neoplasms. - Engagement in regular strength training (more than once a week) during the previous 6 months. - Individuals participating in another research project (within the last 6 months) involving dietary, exercise and/or pharmaceutical intervention - Mini Mental State Examination lower than 24/30 - Severe visual or hearing impairment |
Country | Name | City | State |
---|---|---|---|
Spain | Faculty of Physical Activity and Sports Sciences | Valencia | |
Spain | Municipal Center of Activities for Older People of Campanar | Valencia | |
Spain | Municipal Center of Activities for Older People of Nou Benicalap | Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Valencia | Analclinic: clinical analysis laboratories, Valencia, Spain, City countil of Valencia. Area of Social welfare, Education and Sport, older people section., Labpsitec. Psychology and technology laboratory of the University of Valencia., Municipal Center of Activities for Older People of Campanar, Valencia, Spain, Municipal Center of Activities for Older People of Nou Benicalap, Valencia, Spain, Oxidative Pathology Unit of the Department of Biochemistry and Molecular Biology, University of Valencia., The Faculty of Nursing and Podiatry, University of Valencia., University Clinic of Nutrition, Physical Activity and Physiotherapy CUNAFF, University of Valencia, University Institute of Telematics Medicine, Valencia, Spain |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Level of physical activity | The level of physical activity of the participants will be assessed by Global Physical Activity Questionnaire (GPAQ) | Baseline | |
Other | Cognitive function | The cognitive function will be assessed by the Mini Mental State Examination (MMSE) questionnaire. | Baseline | |
Other | Attendance to training sessions | Daily training session attendance records will be collected by the instructors. | From week 1 to week 20 | |
Other | Adherence to training program | Adherence levels will be calculated at the end of the training period. Nonadherence is define as "those not attending at follow-up and have not attend for 4 weeks during the training period, and have not given a reason for nonattendance or those who have stated they are dropping out." | At week 20 | |
Other | Heart rate during the training exercise sessions | The heart rate will be monitored by the Polar Team System, which allows monitoring the heart rate of different people at the same time. | From week 1 to week 20 | |
Other | Rating of perceived exertion | Will be assessed the perceived exertion during the training sessions asking the level of perceived on the OMNI-RES Scale validated for older adults. | From week 1 to week 20 | |
Other | Change in number of medication used | Will be recorded the number of medication used for each participant. | Baseline and 20 weeks | |
Primary | Change in DNA oxidative stress | The oxidative stress of DNA will be assessed via urine collections of 8-oxo-7,8- dihydro-20-deoxyguanosine (8-OHdG) in nmol/mmol creatinine. | Baseline and 20 weeks | |
Primary | Change in lipid peroxidation | The lipid peroxidation will be assessed via urine and blood collections of 8-isoprostane(nmol /mmol creatinine) and Malondialdehyde (µmol/L) | Baseline and 20 weeks | |
Primary | Change in protein oxidation | The protein oxidation will be assessed via blood collections of protein carbonyl (nmol/L) | Baseline and 20 weeks | |
Primary | Change in antioxidants enzymes | The antioxidants enzymes will be assessed via blood collections of superoxid dismutase (U · mL-1), reduced glutathione (nmol/mg protein), glutathione peroxidase (IU/g Hb), oxidized glutathione (nmol/mg protein), and catalase (IU/g Hb). | Baseline and 20 weeks | |
Primary | Change in metabolic profile | The metabolic profile will be assessed via blood collections of glycosylated hemoglobin A1C (%) and basal glucose (mmol/l). | Baseline and 20 weeks | |
Primary | Change in lipid profile | The lipid profile will be assessed via blood collections total cholesterol (mg/dL), high-density lipoprotein cholesterol (mg/dL), low-density lipoprotein cholesterol (mg/dL) and triglycerides (mg/dL). | Baseline and 20 weeks | |
Primary | Change in immune profile | The immune profile will be assessed via blood collections of platelet counts (10*9/L), plateletcrit (%), mean platelet volum (fl), platelet distribution width (%), leukocytes (% and 10*9/L), neutrophils (% and 10*9/L), lymphocytes (% and 10*9/L), monocytes (% and 10*9/L), eosinophils (% and 10*9/L), basophils (% and 10*9/L). | Baseline and 20 weeks | |
Primary | Change in C-reactive Protein | The C-reactive protein (mg/L) will be assessed via blood collections. | Baseline and 20 weeks | |
Primary | Change in bone metabolism | The bone metabolism will be assessed via blood collections of osteocalcine, and beta crosslaps. | Baseline and 20 weeks | |
Primary | Change in muscle strength | The dynamic maximal concentric muscle strength of the dominant side of hip (abduction and adduction muscle groups), knee and elbow (flexion and extension muscle groups) will be measured with an isokinetic dynamometer (Biodex System 4 Pro; Biodex, Shirley, NY) at two angular velocities, 60°/s and 180°/s. Maximal voluntary concentric isokinetic torque will be assessed in Newton-meters (N-m). The isometric maximal muscle hand grip strength of both hands will be measured with a dynamometer. | Baseline and 20 weeks | |
Primary | Change in functional performance | The functional performance will be assessed with Senior Fitness tests that involve 6 tests: Arm Curl (number of biceps curl in 30 seconds); Chair Stand (stand up from a chair as often as possible within 30s); Back Scratch (for shoulder flexibility, cm between fingertips in the back); Chair sit and reach (for lower flexibility, cm between the extended middle fingers and the tip of the shoe); Up-and-Go (for dynamic balance, time for got up from the chair, walk as quickly as possible around a cone placed 2.4 m from the chair, and resume the seated position); Six-Minute walking test (for aerobic capacity, distance walked in 6 minutes). | Baseline and 20 weeks | |
Primary | Change in lower extremity performance | The lower extremity performance will be assessed with the Short Physical performance battery (SPPB). The SPPB includes an assessment of standing balance, a timed 2.4-meter walk, and a timed test of 5 repetitions of rising from a chair and sitting down (chair-5 time). Each of the three tests is scored, based on performance between 0 and 4, leaving a maximum score of 12 for those individuals performing at the highest levels. Times, measured to the nearest 0.1 second using a stopwatch, for the 2.4-meter walk and chair stand will be used to calculate gait speed and chair-5 time. Balance will be assessed using unilateral stance where subjects are instructed to stand unsupported on the leg of their choice. Time that the leg is off the ground will be recorded. | Baseline and 20 weeks | |
Secondary | Change in 10-meters walking speed | The 10-meters walking speed will be assessed outdoors over a course of 10 m and the time will be recorded. Habitual and maximal walking speeds will be assessed two times by asking participants to walk respectively at ''the speed at which you would walk to the shops'' and ''as fast as possible without running''. | Baseline and 20 weeks | |
Secondary | Change in stair climbing | The time to walk up one flight of stairs will be measured by having the participants walk up one flight of stairs consisting of 23 steps as quickly as possible. The time to complete this task will be recorded to the nearest hundredth of a second using a handheld stopwatch. | Baseline and 20 weeks | |
Secondary | Change in muscle thickness | Muscle thickness (cm) of rectus femoris and biceps brachii of the of the dominant side will be assessed by B-Mode ultrasound (E-Cube 7, Alpinion Medical Systems Co, Seoul, Korea) | Baseline and 20 weeks | |
Secondary | Change in pennation angle | Pennation angle (°) of rectus femoris and biceps brachii of the of the dominant side will be assessed by B-Mode ultrasound (E-Cube 7, Alpinion Medical Systems Co, Seoul, Korea). | Baseline and 20 weeks | |
Secondary | Change in cross-sectional area | Cross-sectional area (cm2) of rectus femoris and biceps brachii of the of the dominant side will be assessed by B-Mode ultrasound (E-Cube 7, Alpinion Medical Systems Co, Seoul, Korea) | Baseline and 20 weeks | |
Secondary | Change in fascicle length | Fascicle length (cm) of rectus femoris and biceps brachii of the of the dominant side will be assessed by B-Mode ultrasound (E-Cube 7, Alpinion Medical Systems Co, Seoul, Korea) | Baseline and 20 weeks | |
Secondary | Change in echo intensity | Echo intensity of rectus femoris and biceps brachii of the of the dominant side will be assessed by B-Mode ultrasound (E-Cube 7, Alpinion Medical Systems Co, Seoul, Korea). Echo Intensity of the rectus femoris and vastus lateralis will be obtained using the same images as for cross-sectional area. Echo intensity will be determined by grayscale analysis using the standard histogram function in ImageJ. Echo intensity in the region of interest will be expressed as arbitrary unit values between 0-255 (0: black; 255: white). | Baseline and 20 weeks | |
Secondary | Change in total mass | Total mass (Kg) will be assessed for whole body and appendicular regions using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA). | Baseline and 20 weeks | |
Secondary | Change in fat mass | Fat mass (Kg) will be assessed for whole body and appendicular regions using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA). | Baseline and 20 weeks | |
Secondary | Change in fat free mass | Fat free mass (Kg) will be assessed for whole body and appendicular regions using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA). | Baseline and 20 weeks | |
Secondary | Change in percentage of fat mass | Percentage of fat mass will be assessed for whole body and appendicular regions using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA). | Baseline and 20 weeks | |
Secondary | Change in waist circumference | Waist circumference will be measured at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest, using a stretch-resistant tape that provides a constant 100g tension in cm. | Baseline and 20 weeks | |
Secondary | Change in hip circumference | Hip circumference will be measured around the widest portion of the buttocks, with the tape parallel to the floor, using a stretch-resistant tape that provides a constant 100 g tension in cm. | Baseline and 20 weeks | |
Secondary | Change in waist/hip ratio | Waist/hip ratio will be assessed by dividing waist circumference by hip circumference. | Baseline and 20 weeks | |
Secondary | Change in waist/height ratio | Waist/height ratio will be assessed by dividing waist circumference by height. | Baseline and 20 weeks | |
Secondary | Change in weight | Weight will be recorded to the nearest 0.01 Kg, using a Tanita® BC-418MA digital scale (Tanita Corp., Tokyo, Japan). | Baseline and 20 weeks | |
Secondary | Height | Height will be recorded to the nearest 0.01 cm using a stadiometer (Seca 711, Hamburg, Germany) | Baseline | |
Secondary | Change in body mass index (BMI) | BMI will be calculated as body weight (kilogram) divided by height (meter) squared (kilogram per square meter). | Baseline and 20 weeks | |
Secondary | Change in bone mineral density (BMD) | BMD (g/cm2) will be assessed for whole body, proximal femur on the non-dominant side (femoral nech, trochanter, intertrochanter, Ward's triangle and total hip) and lumbar spine segments (L1-L4) (L2-L4) (L1-L3) and single vertebrae (L1, L2, L3, L4) will be assessed using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA). | Baseline and 20 weeks | |
Secondary | Change bone mineral content (BMC) | BMC(g) will be assessed for whole body, proximal femur on the non-dominant side (femoral nech, trochanter, intertrochanter, Ward's triangle and total hip) and lumbar spine segments (L1-L4) (L2-L4) (L1-L3) and single vertebrae (L1, L2, L3, L4) will be assessed using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA). | Baseline and 20 weeks | |
Secondary | Change T-Score | T-Score (SD) will be assessed for whole body, proximal femur on the non-dominant side (femoral nech, trochanter, intertrochanter, Ward's triangle and total hip) and lumbar spine segments (L1-L4) (L2-L4) (L1-L3) and single vertebrae (L1, L2, L3, L4) will be assessed using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA). | Baseline and 20 weeks | |
Secondary | Change in Z-Score | Z-Score (SD) will be assessed for whole body, proximal femur on the non-dominant side (femoral nech, trochanter, intertrochanter, Ward's triangle and total hip) and lumbar spine segments (L1-L4) (L2-L4) (L1-L3) and single vertebrae (L1, L2, L3, L4) will be assessed using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA). | Baseline and 20 weeks | |
Secondary | Change in fracture risk | Will be assessed via the FRAX ® tool. | Baseline and 20 weeks | |
Secondary | Change in static balance | Static steady-state balance will be assessed with One-legged stance (OLST) and the Sharpened Romberg test. The OLST will be performed in the standing position, and start when the subjects lift the appropriate foot off the ground. Timing will stop if the subjects displace the foot they will be standing on, touch the suspended foot to the ground, use the suspended foot to support the weight-bearing limb, or reached the maximum balance time of 30 seconds. The participants will perform each test with their eyes open and closed, and both will be performed with the shoes-on and shoes-off conditions. For the Sharpened Romberg test participants will stand erect on a level surface wearing flat shoes with his or her feet aligned in a strict tandem heelto-toe position, arms crossed over the chest, and the open palm of the hand falling on the opposite shoulder. Once stable, the subject will close his or her eyes and will try to maintain that position for 60 seconds. | Baseline and 20 weeks | |
Secondary | Self-reported falls | Self-reported falls will be assessed by the total number of falls during the study period. | Baseline and 20 weeks | |
Secondary | Rate of falls | Rate of falls will be assessed by the total number of falls during the training period compared to the number of falls during the year before the participation on the study. | Baseline and 20 weeks | |
Secondary | Self-perceptions of physical activity | Self-perceptions of the physical activity (training mode) will be assessed by a questionnaire designed by the researchers of the project. | At week 20 | |
Secondary | Change in self-reported quality of life | Will be assessed via Short form quality of life questionnaire (SF36) | Baseline and 20 weeks | |
Secondary | Change in self-reported sleep quality | Will be assessed via The Pittsburgh Sleep Quality Index, a self-rated sleep questionnaire for measuring sleep quality. | Baseline and 20 weeks | |
Secondary | Change in self-reported anxiety | Will be assessed via Overall Anxiety Severity and Impairment Scale (OASIS), a five-item self-report measure of anxiety severity and resulting functional impairment. Scores on the measure range from 0 to 20, with higher scores indicating greater anxiety-related severity and impairment. | Baseline and 20 weeks | |
Secondary | Change in self-reported depression | Will be assessed via Overall Depression Severity and Impairment Scale (ODSIS). The ODSIS was developed to assess depression in the following domains: frequency (Item 1), intensity (Item 2), functional impairment in pleasurable activity (Item 3), work or school (Item 4), and interpersonal relationships (Item 5). Items of ODSIS are scored on a five-point Likert scale of 0-4. Scores on the measure range from 0 to 20, with higher scores indicating greater depression-related severity and impairment. | Baseline and 20 weeks | |
Secondary | Change in basic activities of daily living | Will be assessed via Barthel index of activities of daily living. | Baseline and 20 weeks | |
Secondary | Change in instrumental activities of daily living | Will be assessed via Lawton and Brody instrumental activities of daily living scale. There are eight domains of function measured with the Lawton and Brody scale. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent). | Baseline and 20 weeks | |
Secondary | Nutritional assessment | Nutritional status will be assessed by a 3-day diet records over 2 weekdays and 1 weekend day. Diet records will be analyzed using the program DIAL 3.5.0.3 (ALCE INGENIERIA, Madrid, Spain). | Baseline and 10 weeks | |
Secondary | Adherence to the Mediterranean diet | Adherence to the Mediterranean diet will be assessed by PREDIMED adherence to the Mediterranean diet questionnaire. | Baseline and 10 weeks |
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