Effects of Resistance Training Programes At Different Intensities on Musculoskeletal, Metabolic, Lipid, Immunological, Inflammatory, Well-being and Functional Parameters in Older Adults.

NCT06618469 | Completed

• 2 other identifiers: H1395923230221OTR2015-140931NVES
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

The aging of the global population is recognized by the World Health Organization (WHO) as a major issue due to the disabilities and comorbidities related to this process, with women being the gender most affected. Due to the physiological and psychological age associated declines, physical activity and exercise are proven strategies for reducing the impact of aging. However, it is still unknown what kind of training program could be the most effective in reversing deleterious age-related changes in older adults. Regarding this, the type of training intensity and exercise modality are two key training parameters in exercise programming, and, therefore, different adaptations could be induced in older adults through the modification of these parameters. Furthermore, the type of training device is a significant factor and can act as a barrier or facilitator in older adults\' participation in physical activities and exercise programs. Therefore, the research project primary goals are to compare the effects of resistance training programes performed at different intensities and materials during 32 weeks on a variety of physiological parameters in older adults.

Conditions

Aging

Keywords

Aging; Dose-response; Exercise intensities; Oxidative stress; Physical activity; Bone health; Neuromuscular physiology

Outcome Measures

Primary Outcomes (8)

• 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 16 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 16 weeks

• Change in protein oxidation

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

  Baseline and 16 weeks

• Change in antioxidants enzymes-Superoxid dismutase

  The antioxidants enzymes will be assessed via blood collections of superoxid dismutase (U · mL-1)

  Baseline and 16 weeks

• Change in antioxidants enzymes-reduced glutathione

  The antioxidants enzymes will be assessed via blood collections of reduced glutathione (nmol/mg protein)

  Baseline and 16 weeks

• Change in antioxidants enzymes- Glutathione peroxidase

  The antioxidants enzymes will be assessed via blood collections of glutathione peroxidase (IU/g Hb).

  Baseline and 16 weeks

• Change in antioxidants enzymes-oxidized glutathione

  The antioxidants enzymes will be assessed via blood collections of oxidized glutathione (nmol/mg protein).

  Baseline and 16 weeks

• Change in antioxidants enzymes-Catalase

  The antioxidants enzymes will be assessed via blood collections of catalase (IU/g Hb).

  Baseline and 16 weeks

Secondary Outcomes (22)

• Change in inflammatory profile

  Baseline, 16 and 32 weeks

• Change in renal and hepatic profile

  Baseline, 16 and 32 weeks

• Change in metabolic profile-glycosylated hemoglobin A1C

  Baseline, 16 and 32 weeks

• Change in metabolic profile-basal glucose

  Baseline, 16 and 32weeks

• Change in immune profile-Platelet counts

  Baseline, 16 and 32 weeks

Other Outcomes (24)

• Change in isokinetic muscle strength

  Baseline, 16 and 32 weeks

• Change in maximal muscle hand grip strength

  Baseline, 16 and 32 weeks

• Change in maximal isometric strength

  Baseline, 16 and 32 weeks

Study Arms (6)

Elastic band-based resistance training program at high intensity (HI)

EXPERIMENTAL

Behavioral: Elastic band-based resistance training program at high intensity (HI)

Elastic band-based resistance training program at moderate-high intensity (MHI-bands)

EXPERIMENTAL

Behavioral: Elastic band-based resistance training program at moderate-high intensity (MHI-bands)

Elastic band-based resistance training program at moderate intensity (MI)

EXPERIMENTAL

Behavioral: Elastic band-based resistance training program at moderate intensity (MI)

Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes)

EXPERIMENTAL

Behavioral: Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes)

Water-based resistance training program at moderate intensity (WMI)

EXPERIMENTAL

Behavioral: Water-based resistance training program at moderate intensity (WMI)

Control group

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

Elastic band-based resistance training program at high intensity (HI) BEHAVIORAL

The training session will consist of 5-10 minutes of general warm-up (joint- mobility and aerobic exercises at low intensity); 35-40 minutes of the main part, which comprised six resistance exercises, three for upper limbs (upright rowing, incline rowing, and elbow curl) and three for lower limbs (narrow stance squat, lunge, and standing hip abduction) along with coordination exercises during the active rests; and 5-10 minutes of the cool-down routine (respiratory and flexibility exercises). The participants will perform 6 submaximal repetitions using elastic bands equivalent to 85% of the one-repetition maximum per exercise (high load/intensity training sessions). The perceived exertion level on the OMNI-RES scale progressed from 6-7 to 8-9 . The number of sets per exercise progressed from 3 to 4. The speed of execution of the exercises was controlled using a metronome marking the cadence (2s of concentric and eccentric phase).

Also known as: 1

Elastic band-based resistance training program at high intensity (HI)

Elastic band-based resistance training program at moderate-high intensity (MHI-bands) BEHAVIORAL

The training session will consist of 5-10 minutes of general warm-up (joint- mobility and aerobic exercises at low intensity); 35-40 minutes of the main part, which comprised six resistance exercises, three for upper limbs (upright rowing, incline rowing, and elbow curl) and three for lower limbs (narrow stance squat, lunge, and standing hip abduction) along with coordination exercises during the active rests; and 5-10 minutes of the cool-down routine (respiratory and flexibility exercises). The participants will perform 6 submaximal repetitions using elastic bands equivalent to 75-80% of the one-repetition maximum per exercise (high to moderate load/intensity training sessions). The perceived exertion level on the OMNI-RES scale progressed from 6-7 to 8-9 . The number of sets per exercise progressed from 3 to 4. The speed of execution of the exercises was controlled using a metronome marking the cadence (2s of concentric and eccentric phase).

Also known as: 2

Elastic band-based resistance training program at moderate-high intensity (MHI-bands)

Elastic band-based resistance training program at moderate intensity (MI) BEHAVIORAL

The training session will consist of 5-10 minutes of general warm-up (joint- mobility and aerobic exercises at low intensity); 35-40 minutes of the main part, which comprised six resistance exercises, three for upper limbs (upright rowing, incline rowing, and elbow curl) and three for lower limbs (narrow stance squat, lunge, and standing hip abduction) along with coordination exercises during the active rests; and 5-10 minutes of the cool-down routine (respiratory and flexibility exercises). The participants will perform 6 submaximal repetitions using elastic bands equivalent to 65-70% of the one-repetition maximum per exercise (moderate load/intensity training sessions). The perceived exertion level on the OMNI-RES scale progressed from 6-7 to 8-9. The number of sets per exercise progressed from 3 to 4. The speed of execution of the exercises was controlled using a metronome marking the cadence (2s of concentric and eccentric phase).

Also known as: 3

Elastic band-based resistance training program at moderate intensity (MI)

Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes) BEHAVIORAL

The training session will consist of 5-10 minutes of general warm-up (joint- mobility and aerobic exercises at low intensity); 35-40 minutes of the main part, which comprised six resistance exercises, three for upper limbs (upright rowing, incline rowing, and elbow curl) and three for lower limbs (narrow stance squat, lunge, and standing hip abduction) along with coordination exercises during the active rests; and 5-10 minutes of the cool-down routine (respiratory and flexibility exercises). The participants will perform 6 submaximal repetitions using elastic tubes equivalent to 75-80% of the one-repetition maximum per exercise (high to moderate load/intensity training sessions). The perceived exertion level on the OMNI-RES scale progressed from 6-7 to 8-9 . The number of sets per exercise progressed from 3 to 4. The speed of execution of the exercises was controlled using a metronome marking the cadence (2s of concentric and eccentric phase)

Also known as: 4

Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes)

Water-based resistance training program at moderate intensity (WMI) BEHAVIORAL

The training session will consist of 5-10 minutes of general warm-up (joint- mobility and aerobic exercises at low intensity); 35-40 minutes of the main part, which comprised six resistance exercises, three for upper limbs (upright rowing, incline rowing, and elbow curl) and three for lower limbs (narrow stance leg extension and flexion, hip flexion and extension, and standing hip abduction) along with coordination exercises during the active rests; and 5-10 minutes of the cool-down routine (respiratory and flexibility exercises). The participants will perform in the poll the concentric and eccentric movements of each exercise at maximal velocity during 40 seconds (equivalent to working around 10 repetitions /75% 1RM each exercise). The perceived exertion level on the OMNI-RES scale progressed from 6-7 to 8-9. The number of sets per exercise progressed from 3 to 4.

Also known as: 5

Water-based resistance training program at moderate intensity (WMI)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 60 years
• Physically independent (able to walk 100 m without a walking aid and climb 10 steps without rest)
• On the registration waiting list for physical activity at their respective Municipal Activity Centers for Older People (MACOP).
• Sedentary lifestyle (less than one hour of physical activity or exercise a week during the previous six months).
• Medical certificate of suitability or fitness to practice resistance training activities.
• No plans to leave the area during the intervention.
• Cognitive ability to understand and follow the instructions and sign the informed consent form.
• Free of any antioxidant supplements for at least six weeks before the start of this study.

You may not qualify if:

• Presence of cardiovascular, musculoskeletal, renal, liver, pulmonary, or neuromuscular and neurological disorders that would prevent the participant from performing the exercises.
• Current or prior (past six months) use of hormone replacement therapy.
• Body weight changes \> 10% in the previous year.
• Intake of prescription medications or supplements (e.g., vitamins C, E) that were expected to alter the results of the study (ergogenic, dietary aids, estrogen, beta-blockers, steroid hormones, calcitonin, corticosteroids, glucocorticoids, thiazide diuretics, anticonvulsants, bisphosphonates, raloxifene).
• A history of malignant neoplasms.
• Terminal illness with life expectancy of less than one year.
• Engagement in regular strength training (more than once a week) during the previous six months.
• Participation in another research project (within the last six months) involving dietary, exercise, and/or pharmaceutical intervention.
• Mini mental State Examination lower than 23/30.
• Severe visual or hearing impairment.

Sponsors & Collaborators

• University of Valencia: lead
• Oxidative Pathology Unit of the Department of Biochemistry and Molecular Biology, University of Valencia.: collaborator

Study Sites (1)

Physical activity and Sport Science Faculty

Valencia, Valencia, 46020, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, 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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chaired Full Professor of Physical Education and Sports

Model Details: This is a randomized, duoble-blind (sport scientiest assistance/care assistance-outcome assessor), 6 arms prospective parallel design 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 6 parallel arms study design to a tubes or bands or water resistance training modalities performed at different intensities or a control group over a 32 weeks period.

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: October 1, 2024
• Study Start: May 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)