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临床试验/NCT05481346
NCT05481346Unknown不适用

Psycho-physiological Effects of Multidomain Training in Adults and Older Adults

Universidad de Almeria1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年7月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Body Weight in Kilograms

研究概览

简要总结

The current study aims to determine the effect of a multidomain intervention (physical fitness, motivational and cognitive training) on body composition, sarcopenia, cardiovascular health, physical fitness, functional capacity, quality of life, frailty, emotional state and cognitive status in elderly participants, through a randomized controlled trial, to determine its suitability and recommend it as a preventive and health strategy for community-dwelling older adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
55 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Subject has provided written and dated informed consent to participate in the study.
  • •Subject is a male or female between 55 and 90 years of age, inclusive.
  • •Subject is in good health as determined by a health history questionnaire and has been provided clearance from their personal physician.
  • •Subject is untrained in resistance and aerobic exercise (does not participate in structured physical activity, including walking, more than 3 times per week).
  • •Ability to walk independently without any gait aid

排除标准

  • •Perform high-intensity aerobic exercise on a consistent basis (>180 min-week).
  • •Be performing some other regular and systematic strength training program during the intervention in the first half of
  • •Have a body mass index greater than
  • •Have a diagnosis of ischemic heart disease.
  • •Have a diagnosis of severe aortic stenosis, uncontrolled arrhythmias, decompensated heart failure or acute myocarditis.
  • •Possess uncontrolled blood pressure (TAS >180 and TAD >110).
  • •Severe peripheral arterial disease.
  • •Other illnesses such as recent thromboembolic disease, aortic aneurysm, clinically significant renal or hepatic insufficiency, severe COPD, clinically significant acute infections, severe psychiatric illness, uncontrolled metabolic disease, limiting locomotor pathology or musculoskeletal disease worsened by exercise, hormone therapy at the time or one year prior, being a woman with surgical menopause.
  • •Other pathologies that contraindicate the practice of physical exercise, collected in the previous medical examination that all participants must undergo.

研究组 & 干预措施

Multidomain training group

Experimental

Participants will use free weights and functional materials to work the main muscle groups. In addition, they will perform cardiorespiratory training and cognitive training with proposed tasks. Participants will follow the planned training progression. The researchers will record the number of sets completed and the load lifted for each exercise for each participant and the perception of effort in each class.

干预措施: Multidomain training (Procedure)

Control group

No Intervention

The control group did not receive a training program and were asked not to modify their physical activity habits.

结局指标

主要结局

Body Weight in Kilograms

时间窗: Change from Baseline body weight (kg) at 18 weeks

was measured after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA or InBody equipment to the nearest 0.1 kg.

% Fat Mass

时间窗: Change from Baseline bioelectrical impedance % fat mass at 18 weeks

% fat mass was measured after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA or InBody equipment to the nearest 0.1 kg.

Height in Meters

时间窗: Change from Baseline standing height (cm) at 18 weeks

Standing height without shoes was measured using a Seca 202 stadiometer (Seca, Hamburg, Germany) to the nearest 0.1 cm.

Muscle quality sarcopenia

时间窗: Change from Baseline to 18 weeks

Sarcopenia will be assessed taking into account the reference values established for muscle quality. The muscle quality will be measure by hand grip strength test. This test will be performance with manual dynamometry (TKK 5401; Scientific Instruments Co., Ltd., Tokyo, Japan). Maximal isometric upper limb strength will be performance by maximal isometric strength. Upper strength will be register by kilogrammes. Higher value show high strength.

Body Mass Index (BMI)

时间窗: Change from Baseline Body Mass Index (BMI): (kg/m^2) at 18 weeks

was calculated as the ratio of weight to squared height in kg/m\^2

次要结局

  • Gait speed(Change from Baseline to 18 weeks)
  • Fragility(Change from Baseline to 18 weeks)
  • Health-related quality(Change from Baseline to 18 weeks)
  • Change Blood pressure(Change from Baseline to 18 weeks)
  • Change Upper and Lower strength(Change from Baseline to 18 weeks)
  • Depression(Change from Baseline to 18 weeks)
  • PSQ test(Change from Baseline to 18 weeks)
  • Cardiorrespiratory 6 minutes walk test(Change from Baseline to 18 weeks)
  • Change heart rate(Change from Baseline to 18 weeks)
  • Satisfaction with life(Change from Baseline to 18 weeks)
  • TMMS-24(Change from Baseline to 18 weeks)
  • Change Chair stand test(Change from Baseline to 18 weeks)
  • Short physical performance battery (SPPB)(Change from Baseline to 18 weeks)
  • Cognitive flexibility(Change from Baseline to 18 weeks)
  • Attention test(Change from Baseline to 18 weeks)
  • Time up and go test change(Change from Baseline to 18 weeks)

研究者

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

Pablo Jorge Marcos Pardo

Principal investigator

Universidad de Almeria

研究点 (1)

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