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临床试验/NCT06618469
NCT06618469已完成不适用

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

University of Valencia2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
320
试验地点
2
主要终点
Change in antioxidants enzymes-reduced glutathione

研究概览

简要总结

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.

详细描述

This is a randomized clinical trial (RCT) with 6 parallel arms. The subjects will be divided in 6 groups with a randomized technique assigned to a 32-week of: a) progressive elastic band-based resistance training program at high intensity (HI); b) progressive elastic band-based resistance training program at moderate-high intensity (MHI-bands); c) progressive elastic band-based resistance training program at moderate intensity (MI); d) progressive elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes); e) progressive water-resistance training program at moderate intensity (WMI); f) self-management control group (CG). The subjects will be submitted to a 2-session familiarization period and then a 32-week of training program will be performed twice a week.

The exercise groups engaged in progressive elastic-based (bands of tubes) resistance training twice a week with three to four sets of six (HI), 10 (MHI) or 15 (MI) submaximal repetitions including six overall body exercises at a rate of perceived exertion (RPE) of 6-7 in the first four weeks and 8-9 in the remaining weeks on the OMNI-Resistance Exercise Scale (RES). The water-resistance group will perform similar exercises adapted to the water environment at maximal effort (maximal speed in the concentric and eccentric phases of each repetition) during 40 seconds. Members of the control group were instructed to continue their everyday lives.

Oxidative stress, bone health, body composition, neuromuscular strength, physical function, quality of life, lipidic, immune and cardiometabolic profile will be assessed. Oxidative stress status will be assessed in deoxyribonucleic acid (DNA) (urinary 8-oxo-2-deoxyguanosine [8-oxo-dG], lipids (F2-isoprostanes[8-iso-P]; malonaldehyde [MDA], and proteins (protein carbonyls) products together with antioxidant enzymes (superoxide dismutase [SOD] and glutathione peroxidase [GPx]), and thiol redox state (reduced glutathione [GSH], oxidized glutathione [GSSG], and the GSSG/GSH ratio. Bone health will be integrated by measures of areal bone mineral density (aBMD) and the T-score of the lumbar spine (L1-L4 segments, L2-L4 segments, and L1, L2, L3, and L4 individual vertebrae) and proximal femur (femoral neck, trochanter, intertrochanter, Ward's triangle, and total hip in both projects) will be assessed by dual-energy X-ray absorptiometry (DXA). Additionally bone health will be also composed by fracture risk (the 10-year probability of a major osteoporotic fracture and the 10-year probability of a hip fracture), bone turnover markers (BTMs) of bone formation (procollagen type I N propeptide [P1NP], a bone-specific isoform of alkaline phosphatase [bALP]) and bone resorption (a β-isomerized form of C-terminal telopeptide of type I collagen [β-CTx]), and their relationship (bALP/ β-CTx ratio). Body composition (total body mass, total fat mass, total fat-free mass, and total body fat percentage) will be measured by DXA. Moreover, the neuromuscular strength of upper limbs (elbow flexor and extensor muscles) and lower limbs (hip abductor and hip adductor along with knee flexor and extensor muscles) will be assessed through isokinetic dynamometry at low (60°/s) and high (180°/s) velocities. Finally, physical performance will be measured using various functional tests and batteries widely used in the literature, such as the 30 seconds chair stand (30sec-CS) and 30 seconds arm curl (30sec-AC) for muscle strength/endurance of the lower and upper limbs; time up and go (TUG) for dynamic balance/agility; the six-minute walking test (6MWT) for aerobic endurance; five sit-to stand.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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/
  • Severe visual or hearing impairment.

结局指标

主要结局

Change in antioxidants enzymes-reduced glutathione

时间窗: Baseline and 16 weeks

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

Change in DNA oxidative stress

时间窗: Baseline and 16 weeks

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.

Change in lipid peroxidation

时间窗: Baseline and 16 weeks

The lipid peroxidation will be assessed via urine and blood collections of 8-isoprostane(nmol /mmol creatinine) and Malondialdehyde (μmol/L)

Change in protein oxidation

时间窗: Baseline and 16 weeks

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

Change in antioxidants enzymes-Superoxid dismutase

时间窗: Baseline and 16 weeks

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

Change in antioxidants enzymes- Glutathione peroxidase

时间窗: Baseline and 16 weeks

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

Change in antioxidants enzymes-oxidized glutathione

时间窗: Baseline and 16 weeks

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

Change in antioxidants enzymes-Catalase

时间窗: Baseline and 16 weeks

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

次要结局

  • 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)
  • Change in immune profile-plateletcrit(Baseline, 16 and 32 weeks)
  • Change in immune profile-mean platelet volum(Baseline, 16 and 32 weeks)
  • Change in immune profile-platelet distribution width(Baseline, 16 and 32 weeks)
  • Change in immune profile-leukocites(Baseline, 16 and 32 weeks)
  • Change in immune profile- neutrophils(Baseline, 16 and 32 weeks)
  • Change in immune profile-lymphocytes(Baseline, 16 and 32 weeks)
  • Change in lipid profile-triglycerides(Baseline, 16 and 32 weeks)
  • Change in immune profile-monocytes(Baseline, 16 and 32 weeks)
  • Change in immune profile-eosinophils(Baseline, 16 and 32 weeks)
  • Change in immune profile-basophils(Baseline, 16 and 32 weeks)
  • Change in lipid profile-total cholesterol(Baseline, 16 and 32 weeks)
  • Change in lipid profile-high-density lipoprotein cholesterol(Baseline, 16 and 32 weeks)
  • Change in lipid profile-low-density lipoprotein cholesterol(Baseline, 16 and 32 weeks)
  • Change in lipid profile-apolipoprotein B/apolipoprotein A(Baseline, 16 and 32 weeks)
  • Change in bone metabolism - Type I procollagen N-terminal propeptide (Bone formation)(Baseline, 16 and 32 weeks)
  • Change in bone metabolism - Bone alkaline phosphatase (Bone formation)(Baseline, 16 and 32 weeks)
  • Change in bone metabolism - terminal telopeptide of collagen type I (bone resorption)(Baseline, 16 and 32 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan C. Colado

Chaired Full Professor of Physical Education and Sports

University of Valencia

研究点 (2)

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