NCT03455179

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

February 21, 2018

Last Update Submit

October 23, 2018

Conditions

Keywords

OlderPhysical functionPower trainingOxidative stressElastic bandOMNI-RES perceived exertion scaleStrength training

Outcome Measures

Primary Outcomes (12)

  • 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

  • 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

  • Change in protein oxidation

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

    Baseline and 20 weeks

  • 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

  • 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

  • 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

  • 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

  • Change in C-reactive Protein

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

    Baseline and 20 weeks

  • Change in bone metabolism

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

    Baseline and 20 weeks

  • 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

  • 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

  • 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 Outcomes (35)

  • Change in 10-meters walking speed

    Baseline and 20 weeks

  • Change in stair climbing

    Baseline and 20 weeks

  • Change in muscle thickness

    Baseline and 20 weeks

  • Change in pennation angle

    Baseline and 20 weeks

  • Change in cross-sectional area

    Baseline and 20 weeks

  • +30 more secondary outcomes

Other Outcomes (7)

  • Level of physical activity

    Baseline

  • Cognitive function

    Baseline

  • Attendance to training sessions

    From week 1 to week 20

  • +4 more other outcomes

Study Arms (4)

Slow-speed traditional resistance training

EXPERIMENTAL

Resistance 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.

Other: Slow-speed traditional resistance training

High-speed resistance training

EXPERIMENTAL

Resistance 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.

Other: High-speed resistance training

Multicomponent training

EXPERIMENTAL

Training sessions with balance, resistance, aerobic, flexibility and coordination components twice a week over 20 weeks.

Other: Multicomponent training

Control

NO INTERVENTION

Participants randomized into the CONTROL group will not undertake any formal intervention and will be asked to maintain their usual physical activity habits and diet.

Interventions

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).

Slow-speed traditional 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.

Also known as: Power training, Explosive resistance training
High-speed resistance training

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.

Multicomponent training

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Faculty of Physical Activity and Sports Sciences

Valencia, 46010, Spain

Location

Municipal Center of Activities for Older People of Campanar

Valencia, 46015, Spain

Location

Municipal Center of Activities for Older People of Nou Benicalap

Valencia, 46025, Spain

Location

Related Publications (1)

  • 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.

Study Officials

  • Juan Carlos Colado Sánchez, Full professor

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
For masking the participants, the investigators will not inform participants of what group they will be in. For outcome assessor, data collectors and data analysts independent people will be use, and if this is not possible, a random code will be created for each participant so that it is not possible to identify which group belongs to.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor of the Department of Physical Education and Sports

Study Record Dates

First Submitted

February 21, 2018

First Posted

March 6, 2018

Study Start

March 5, 2018

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

October 24, 2018

Record last verified: 2018-10

Locations