AzTrials
AzTrials

AgingNCT03455179

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.

A study testing Slow-speed traditional resistance training, High-speed resistance training and Multicomponent training in people with Aging, run by University of Valencia at 3 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Slow-speed traditional resistance training, High-speed resistance training and Multicomponent training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
3 sitesSpain
Study dates
5 Mar 2018to 31 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Spain3 sites
  • Faculty of Physical Activity and Sports Sciences

    Valencia, 46010

  • Municipal Center of Activities for Older People of Campanar

    Valencia, 46015

  • Municipal Center of Activities for Older People of Nou Benicalap

    Valencia, 46025

Other trials in Spain

About this study

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.

Read the detailed description

Slow-speed traditional resistance training (2-3 seconds for each concentric and eccentric phase) protocols for the elderly have involved relatively heavy loads (70-80% of maximum force) in order to increase strength and function, and has been demonstrated to be an effective strategy to improve biomarkers of health and fitness across a wide range of healthy and clinical older populations, but the results regarding the function are inconsistent in the current literature. However, several studies indicated that muscle power is a stronger predictor than strength for daily motor activities, such as fast walking, stair-climbing, and rising from a chair, and that peak muscle power was associated with functional limitations in older people. Moreover, muscle power declines earlier and at a higher rate than strength. More recently, several authors have designed high-speed resistance training programs, also calling power training or explosive-type resistance training to improve muscle power in older adults rather than strength. However, the effects of high-speed resistance training versus slow-speed traditional resistance training on functional outcomes in older adults are inconsistent, with some studies showing enhanced improvements in function, and others showing no difference in function perhaps because to the application of different training parameters, tests, functional status of the participants or the lengths of the studies. Furthermore, the effects of the high-speed training programs on others variables such as oxidative stress, bone profile or metabolic function are unknown.

On the other hand, current recommendations have recognized that a combination of aerobic activity, strength training and flexibility exercises is important for maintaining physical function in older adults. However, most studies in older individuals have examined the isolated effect of strength and endurance training programs and focused on different health-related fitness parameters. Also, due to the low rates of physical activity in older adults, especially regarding resistance training (11%), it is necessary to study the effects of other types of physical activity possibly more dynamics, like the multicomponent training. Multicomponent training is defined as a well-rounded program that includes endurance, strength, coordination, balance and flexibility exercises and is becoming increasingly popular among the older population and appears to be associated with several health benefits because has the potential to impact both cardiorespiratory and neuromuscular fitness, which both play an important role in maintaining functional fitness and quality of life.

Currently however, there is no evidence which has examined the effectiveness of high-speed resistance training and multicomponent training in older adults (>60 years) in front of slow-speed traditional training not only in respect of the physical function, but also in terms of oxidative stress, bone profile, metabolic status and quality of life. Developing an understanding of novel training strategies can ultimately provide a viable alternative to traditional modes of exercise training for a broader range of participants and increase their adherence to them.

This is a randomized clinical trial (RCT) with 4 parallel arms. The subjects will be divided in 4 groups with a randomized technique: slow-speed traditional resistance training group (TRADITIONAL), high-speed resistance training group (H-SPEED), multicomponent training group (MULTICOMPONENT) and control group (CONTROL). The subjects will be submitted to a 4-session familiarization period and then a 20-week of training program will be performed twice a week.

The TRADITIONAL group will perform 6 submaximal repetitions equivalent to 85% of the one-repetition maximum (1RM) per exercise (high intensity training sessions). The perceived exertion level on the OMNI-RES scale progressed from 6-7 (somewhat hard) in the first 4 weeks to 8-9 (hard) in the remaining 16 weeks. Control of the intensity by this method (which takes into account the grip width, band color, and number of bands) has been previously validated in young adults, middle aged adults, and older adults, and will be the first time that it will be used the validate scale for older adults in the intervention training. The number of sets per exercise progressed from 3 in the first 8 weeks to 4 in the remaining 12 weeks in both groups, with 120s of active recovery (slow rhythmic swinging of the extremities without the use of elastic bands) between sets and 90s of rest between exercises. The speed of execution of the exercises was controlled using a metronome marking the cadence (2s of concentric contraction and 2s of eccentric contraction). The training session will consist in a general warm-up, 6 resistance exercises, including 2 upper limb exercises (elbow curl and chest press), 2 lower limb exercises (lunge and standing hip abduction), and 2 exercises combining both upper and lower limbs at the same time (squat plus upright rowing and squat plus shoulder press) and finally the cooldown routine. Primarily multijoint exercises were chosen to emphasize both major and minor muscle groups.

The H-SPEED group will perform the same routine than the TRADICIONAL group (the same general warm-up, the same 6 resistance exercises and the same cooldown routine) with the difference that this group will perform the concentric phase of each repetition in the resistance exercises ''as fast as possible'', will pause for 1 second, and will perform the eccentric phase in 2-3 seconds (the speed of execution of the exercises was controlled using a metronome). This group will perform 12 submaximal repetitions with very low perceived exertion (3 of 10) and ''rapid´´ in the qualitative perceived exertion scale for power training, equivalent to 40-50% 1RM (low-intensity). The number of sets per exercise progressed from 3 in the first 8 weeks to 4 in the remaining 12 weeks, with 90s of active recovery between sets (slow rhythmic swinging of the extremities without the use of elastic bands) and 60s of rest between exercises.

The MULTICOMPONENT group sessions will include a resistance training component, but will combine it with additional exercise regimens including balance, aerobic, flexibility and coordination. Participants will perform, in this order, balance exercises followed by resistance/coordination, aerobic/coordination and flexibility exercises in each session. The balance training will consist in static, dynamic and proactive balance exercises. In the resistance training block, the participants will perform 15 submaximal repetitions with a perceived exertion level on the OMNI-RES Scale 6-7 (somewhat hard) in the first 8 weeks and 8-9 (hard) in the remaining 12 weeks. Participants will perform 2 resistance exercises (squat plus upright rowing and lunge) at traditional slow-speed (2s of concentric contraction and 2s of eccentric contraction). The number of sets per exercise will progress from 3 in the first 8 weeks to 4 in the remaining 12 weeks, with 90s of active recovery between sets and 60s of rest between exercises. Given the demonstrated importance of reproducing the different challenges encountered in daily life, will be proposed in the aerobic part of the session exercises that will require moving through space using walking progressively at faster speeds to light skipping, jogging, or with longer steps, and while adding the use of the arms. The heart rate will be monitored by the polar team system, which allows monitoring the heart rate of different people at the same time. The intensity of this part will progress from 65 to 85% of the maximum heart rate over the training weeks. The flexibility block will consist in static stretching exercises of upper and lower limbs. Finally, the coordination exercises will be performed in the rests periods of resistance and aerobic blocks, and will consist of psychomotor (reaction time) exercises, dance movements and obstacle exercises. Specific cognitive challenges were integrated also into this block (coordination) to engage executive function, and to specifically stimulate the inhibition of habitual responses and cognitive flexibility. For instance, participants will have to perform task sequences while reversing or ''scattering'' a learned order, or to learn different stimulus-response associations and then switch between them according to external cues. The difficulty of balance and coordination exercises will increase progressively to generate adaptations.

The subjects will perform four sessions of pre-intervention familiarization to (a) select the color, grip width, and number of bands; (b) adapt the rate of perceived exertion; and (c) learn the correct technique for the exercises. The loads will be adjusted every week to maintain the appropriate training intensities by adapting the color and number of elastic bands along with the grip width. Training attendance will be recorded at every session. All the training sessions will be performed in two Municipal Activity Centers for Older People located in Valencia (Campanar and Nou Benicalap centers), under the supervision of a qualified and experienced sports scientist and physiotherapists to ensure safety and compliance.

All the supervised programs will include 2 weekly sessions will perform on nonconsecutive days (separated by 48-72 hr) for 20 weeks. Each session will be performed in groups, and each participant always will perform the exercises in the same order, alternating between the upper and lower limbs. Elastic bands (TheraBand®, Akron, OH, USA) and chairs will be used as the equipment.

Conditions
Aging
Being tested
Slow-speed traditional resistance training, High-speed resistance training, Multicomponent training
Keywords
Older, Physical function, Power training, Oxidative stress, Elastic band, OMNI-RES perceived exertion scale, Strength training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Slow-speed traditional resistance trainingOther

    The training session will consist in a general warm-up, 6 resistance exercises, including 2 upper limb exercises (elbow curl and chest press), 2 lower limb exercises (lunge and standing hip abduction), and 2 exercises combining both upper and lower limbs at the same time (squat plus upright rowing and squat plus shoulder press) and finally the cooldown routine.The participants will perform in each training session 6 submaximal repetitions equivalent to 85% of the one-repetition maximum (1RM) and 3-4 sets per exercise (high intensity training sessions).

  • High-speed resistance trainingOther

    Also called Power training, Explosive resistance training

    The participants will perform the same exercises than the TRADICIONAL group with12 submaximal repetitions equivalent to 40-50% 1RM (low-intensity) and 3-4 sets per exercise.

  • Multicomponent trainingOther

    Participants will perform, in this order, balance exercises followed by resistance/coordination, aerobic/coordination and flexibility exercises in each session. The balance training will consist in static, dynamic and proactive balance exercises. In the resistance training block, the participants will perform 3-4 sets of 15 submaximal repetitions Participants will perform 2 resistance exercises (squat plus upright rowing and lunge) at traditional slow-speed (2s of concentric contraction and 2s of eccentric contraction).The intensity of the aerobic block will progress from 65 to 85% of the maximum heart rate over the training weeks.

Study groups in NCT03455179
Study groupRoleWhat they receive
Slow-speed traditional resistance trainingExperimentalResistance training with variable resistances (elastic band) at high intensity and slow-speed (2s of concentric contraction and 2s of eccentric contraction) twice a week over 20 weeks.
Receives: Other: Slow-speed traditional resistance training
High-speed resistance trainingExperimentalResistance training with variable resistances (elastic band) at low intensity and high-speed (''as fast as possible´´ for the concentric contraction, pause for 1 second and 2-3 seconds for the eccentric contraction) twice a week over 20 weeks.
Receives: Other: High-speed resistance training
Multicomponent trainingExperimentalTraining sessions with balance, resistance, aerobic, flexibility and coordination components twice a week over 20 weeks.
Receives: Other: Multicomponent training
ControlNo interventionParticipants randomized into the CONTROL group will not undertake any formal intervention and will be asked to maintain their usual physical activity habits and diet.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 20 weeks

  2. 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)

    Measured: Baseline and 20 weeks

  3. Change in protein oxidation

    The protein oxidation will be assessed via blood collections of protein carbonyl (nmol/L)

    Measured: Baseline and 20 weeks

  4. 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).

    Measured: Baseline and 20 weeks

  5. Change in metabolic profile

    The metabolic profile will be assessed via blood collections of glycosylated hemoglobin A1C (%) and basal glucose (mmol/l).

    Measured: Baseline and 20 weeks

  6. 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).

    Measured: Baseline and 20 weeks

  7. 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).

    Measured: Baseline and 20 weeks

  8. Change in C-reactive Protein

    The C-reactive protein (mg/L) will be assessed via blood collections.

    Measured: Baseline and 20 weeks

  9. Change in bone metabolism

    The bone metabolism will be assessed via blood collections of osteocalcine, and beta crosslaps.

    Measured: Baseline and 20 weeks

  10. 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.

    Measured: Baseline and 20 weeks

  11. 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).

    Measured: Baseline and 20 weeks

  12. 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.

    Measured: Baseline and 20 weeks

Secondary outcomes (35)
  1. 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''.

    Measured: Baseline and 20 weeks

  2. 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.

    Measured: Baseline and 20 weeks

  3. 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)

    Measured: Baseline and 20 weeks

  4. 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).

    Measured: Baseline and 20 weeks

  5. 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)

    Measured: Baseline and 20 weeks

  6. 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)

    Measured: Baseline and 20 weeks

  7. 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).

    Measured: Baseline and 20 weeks

  8. 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).

    Measured: Baseline and 20 weeks

  9. 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).

    Measured: Baseline and 20 weeks

  10. 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).

    Measured: Baseline and 20 weeks

  11. 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).

    Measured: Baseline and 20 weeks

  12. 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.

    Measured: Baseline and 20 weeks

  13. 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.

    Measured: Baseline and 20 weeks

  14. Change in waist/hip ratio

    Waist/hip ratio will be assessed by dividing waist circumference by hip circumference.

    Measured: Baseline and 20 weeks

  15. Change in waist/height ratio

    Waist/height ratio will be assessed by dividing waist circumference by height.

    Measured: Baseline and 20 weeks

  16. Change in weight

    Weight will be recorded to the nearest 0.01 Kg, using a Tanita® BC-418MA digital scale (Tanita Corp., Tokyo, Japan).

    Measured: Baseline and 20 weeks

  17. Height

    Height will be recorded to the nearest 0.01 cm using a stadiometer (Seca 711, Hamburg, Germany)

    Measured: Baseline

  18. Change in body mass index (BMI)

    BMI will be calculated as body weight (kilogram) divided by height (meter) squared (kilogram per square meter).

    Measured: Baseline and 20 weeks

  19. 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).

    Measured: Baseline and 20 weeks

  20. 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).

    Measured: Baseline and 20 weeks

  21. 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).

    Measured: Baseline and 20 weeks

  22. 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).

    Measured: Baseline and 20 weeks

  23. Change in fracture risk

    Will be assessed via the FRAX ® tool.

    Measured: Baseline and 20 weeks

  24. 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.

    Measured: Baseline and 20 weeks

  25. Self-reported falls

    Self-reported falls will be assessed by the total number of falls during the study period.

    Measured: Baseline and 20 weeks

  26. 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.

    Measured: Baseline and 20 weeks

  27. 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.

    Measured: At week 20

  28. Change in self-reported quality of life

    Will be assessed via Short form quality of life questionnaire (SF36)

    Measured: Baseline and 20 weeks

  29. Change in self-reported sleep quality

    Will be assessed via The Pittsburgh Sleep Quality Index, a self-rated sleep questionnaire for measuring sleep quality.

    Measured: Baseline and 20 weeks

  30. 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.

    Measured: Baseline and 20 weeks

  31. 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.

    Measured: Baseline and 20 weeks

  32. Change in basic activities of daily living

    Will be assessed via Barthel index of activities of daily living.

    Measured: Baseline and 20 weeks

  33. 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).

    Measured: Baseline and 20 weeks

  34. 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).

    Measured: Baseline and 10 weeks

  35. Adherence to the Mediterranean diet

    Adherence to the Mediterranean diet will be assessed by PREDIMED adherence to the Mediterranean diet questionnaire.

    Measured: Baseline and 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2018
  2. Study start5 Mar 2018
  3. Primary completion31 Jul 2018
  4. Study completion31 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized, duoble-blind (participant-outcome assessor), 4 arms prospective parrallel desing clinical trial. The older adults will be recruited from the Municipal Activity Centers for Older People located in Valencia and will be randomized in a prospective clinical trial study with a 4 parallel arms study design to a slow-speed traditional resistance training, high-speed resistance training, multicomponent training or control over a 20 weeks period.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03455179
Sponsor's protocol ID
H1508742840440
Status last verified
Oct 2018
First submitted
21 Feb 2018
Last updated
24 Oct 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gargallo P, Tamayo E, Jimenez-Martinez P, Juesas A, Casana J, Benitez-Martinez JC, Gene-Morales J, Fernandez-Garrido J, Saez GT, Colado JC. Multicomponent and power training with elastic bands improve metabolic and inflammatory parameters, body composition and anthropometry, and physical function in older women with metabolic syndrome: A 20-week randomized, controlled trial. Exp Gerontol. 2024 Jan;185:112340. doi: 10.1016/j.exger.2023.112340. Epub 2023 Dec 11.

    PubMed 38061437

Questions about this trial

What is this clinical trial studying?

A study testing Slow-speed traditional resistance training, High-speed resistance training and Multicomponent training in people with Aging, run by University of Valencia at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in DNA oxidative stress (time frame: Baseline and 20 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03455179, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in