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临床试验/NCT04958499
NCT04958499已完成不适用

Physical and Psychological Effectiveness of Bio-Healthy Park on Adult

Universidad Católica San Antonio de Murcia1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Muscle quality sarcopenia

研究概览

简要总结

Bio-healthy parks are an alternative for practicing physical activity outdoors and free of charge. However, there is no research that analyzes the effect of a planned training program in these parks. There are two types of parks under development, with and without externally added resistance. Therefore, general objective of this project are to evaluate the effect of 8 weeks of targeted training in bio-healthy parks on body composition, bone mineral density, blood pressure, strength, functional capacity, sarcopenia, sagittal disposition of the spine, quality of life, life satisfaction and Mediterranean diet adherence in adults and older adults. The present project will be developed through a randomized controlled trial, with 1 experimental and 1 control group, with pre-test and post-test, with intra-group and inter-group analysis for each of the dependent variables of the study. It will be measure body composition, bone mineral density, blood pressure, upper limb strength, lower limb strength, functional capacity, sarcopenia, sagittal disposition of the spine, Health-related quality of life, satisfaction with life and Mediterranean diet adherence. Experimental group will receive the exercise program on bio-healthy park machine with a frequency of 2 sessions per week of 55 minutes for 8 weeks. The control group will not perform any intervention program following their usual activity.

详细描述

The aging process is associated with physiological, psychological and functional deterioration. It has been demonstrated that the practice of physical activity can prevent, slow or reduce this deterioration. Bio-healthy parks are an alternative for practicing physical activity outdoors and free of charge. However, there is no research that analyzes the effect of a planned training program in these parks. There are two types of parks under development, with and without externally added resistance.

Therefore, the objectives of this project are to evaluate the effect of 8 weeks of targeted training in bio-healthy parks, with a frequency of 2 sessions per week on body composition, bone mineral density, blood pressure, strength, functional capacity, sarcopenia, sagittal disposition of the spine, quality of life, life satisfaction and mediterranean diet satisfaction in adults and older adults.

The present project will be developed through a randomized controlled trial, with 1 experimental and 1 control group, with pre-test and post-test, with intra-group and inter-group analysis for each of the dependent variables of the study.

The inclusion criteria are: (a) not having participated in a structured exercise program for at least 1 year, (b) being older than 50 years of age, and (c) being physically independent. The exclusion criteria are: (a) having musculoskeletal injuries or limitations that could affect the health and physical performance of the person; (b) being under medical prescription for taking medications that could influence physical performance; (c) not regularly attending the proposed sessions.

Body composition and bone mineral density will be assessed by dual energy X-ray absorptiometry (DEXA).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • not having participated in a structured exercise program for at least 1 year;
  • being older than 50 years of age
  • being physically independent.

排除标准

  • having musculoskeletal injuries or limitations that could affect the person's health and physical performance
  • being under medical prescription for taking medications that could influence physical performance
  • not regularly attending the proposed sessions.

结局指标

主要结局

Muscle quality sarcopenia

时间窗: Changes from baseline to 8 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.

次要结局

  • Change Blood pressure(Changes from baseline to 8 weeks)
  • Change Upper strength(Changes from baseline to 8 weeks)
  • Satisfaction with Life Scale (SWL)(Changes from baseline to 8 weeks)
  • Change Chair stand test(Changes from baseline to 8 weeks)
  • Change Sagittal spinal curvature(Changes from baseline to 8 weeks)
  • Change bone mineral density(Changes from baseline to 8 weeks)
  • Gait speed change(Changes from baseline to 8 weeks)
  • Change in lower limb strenght(Changes from baseline to 8 weeks)
  • Change Body composition(Changes from baseline to 8 weeks)
  • Change heart rate(Changes from baseline to 8 weeks)
  • Health-related quality(Changes from baseline to 8 weeks)
  • Adherence to the Mediterranean diet(Changes from baseline to 8 weeks)
  • Functional competence 400 meter walk(Changes from baseline to 8 weeks)
  • Time up and go test change(Changes from baseline to 8 weeks)
  • Short physical performance battery (SPPB)(Changes from baseline to 8 weeks)

研究者

发起方
Universidad Católica San Antonio de Murcia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Noelia González-Gálvez

Principal investigator

Universidad Católica San Antonio de Murcia

研究点 (1)

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