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临床试验/NCT07529158
NCT07529158已完成不适用

Cardiorespiratory Prevention and Rehabilitation Program (PROCOR)

Universidade Federal de Santa Catarina1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
change in strength

研究概览

简要总结

The global aging of the population presents significant challenges to health and quality of life, especially among the elderly, who face a higher prevalence of cardiometabolic risk factors. Additionally, aging is associated with increases in blood pressure (BP) and a gradual loss of functional capacity. On the other hand, physical exercise improves various cardiometabolic and functional aspects of the elderly. However, determining the ideal weekly frequency of physical training for this population is uncertain, requiring further investigation of the manipulation of this training variable on overall health parameters. Therefore, the aim of this study was to compare the effect of two different weekly frequencies of combined training on the functional capacity, hemodynamic, and anthropometric aspects of elderly individuals with cardiometabolic risk factors. The study adopted an uncontrolled clinical trial design, focused on investigating the effects of combined training over 12 weeks, conducted at the Federal University of Santa Catarina (UFSC) and involved elderly participants from the Cardiopulmonary Prevention and Rehabilitation Program (PROCOR). Participants underwent a wide range of assessments, including anthropometric measurements, functional capacity tests through the Senior Fitness Test battery and the 1000-meter test, as well as blood pressure assessments using automatic equipment. Then, participants were divided into two groups: G2x, which trained twice a week, and G3x, which trained three times a week during the intervention period, which consisted of three mesocycles of four weeks each with intensity progression. Data analysis was performed by intention-to-treat (ITT) and per-protocol (PP), using generalized estimating equations, with Bonferroni post-hoc adjustment.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Have a diagnosis of hypertension, diabetes mellitus, and/or another cardiovascular disease;
  • Provide medical documentation confirming the diagnosis (e.g., medical report or prescription);
  • Present a medical clearance for participation in physical exercise issued by a cardiologist or endocrinologist;
  • If diagnosed with cardiovascular disease, provide a recent exercise stress test at the beginning of the study.

排除标准

  • Not properly using medication for an existing chronic condition;
  • Presenting severe complications of the existing chronic condition (e.g., severe autonomic neuropathy in individuals with Diabetes);
  • Having muscular and/or joint impairments that prevent the performance of physical exercise.

研究组 & 干预措施

Exercise Group 2 times per week

Experimental

The group training twice per week (G2x) performed sessions on Tuesdays and Thursdays. The training consisted in aerobic exercise combined with strength training. Further details are specified in the intervention description.

干预措施: PROCOR 2024.1 (Behavioral)

Exercise Group 3 times per week

Experimental

The group trained three times a week (G3x) had sessions on Tuesdays, Thursdays, and Fridays. For those who trained three times a week, two sessions with speed variation and one with incline were assigned. The training consisted in aerobic exercise combined with strength training. Further details are specified in the intervention description.

干预措施: PROCOR 2024.1 (Behavioral)

结局指标

主要结局

change in strength

时间窗: Baseline and 12 weeks

Lower limb strength was measured using the 30-second sit-to-stand test. The test result used was the number of repetitions performed in this time, in one attempt. Upper limb strength was assessed using the 30-second arm curl test, with a 2.0 kg dumbbell for women and a 4.0 kg dumbbell for men. The test result was the total number of curls completed in a single attempt with the dominant arm.

change in balance/Agility

时间窗: Baseline and 12 weeks

Agility/dynamic balance was measured using the Timed Up and Go (TUG) test. The test result was the shortest time to stand up from a seated position, walk 3.00 meters, turn around, and return to the seated position. The TUG was performed at two walking speeds (maximum and usual), with two attempts for each, and the shortest time of each speed was recorded.

change in flexibility

时间窗: Baseline and 12 weeks

Flexibility was assessed using the sit-and-reach test, in which participants sat on a mat with their legs fully extended and their feet placed against a box used for the test, reaching forward. The total distance reached represented the final score, with two reach attempts recorded.

change in cardiorespiratory fitness

时间窗: Baseline and 12 weeks

Aerobic capacity was evaluated using two tests: the 6-minute walk test (6MWT), which participants completed one attempt, and the result was the total distance covered in that time; and the 1000-meter test (1000m), that was developed due to the presence of a ceiling effect observed in the 6MWT in many participants in previous PROCOR training semesters, in which participants also made one attempt, and the score was the total time in seconds to complete the distance, allowing walking and/or running.

次要结局

  • Change in clinic systolic blood pressure(Baseline and 12 weeks)
  • Change in clinic diastolic blood pressure(Baseline and 12 weeks)
  • Change in clinic mean blood pressure(Baseline and 12 weeks)
  • change in fasting glucose(Baseline and 12 weeks)
  • change in total cholesterol(Baseline and 12 weeks)
  • change in HDL-cholesterol(Baseline and 12 weeks)
  • change in triglycerides(Baseline and 12 weeks)

研究者

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

Aline Mendes Gerage

Principal Investigator

Universidade Federal de Santa Catarina

研究点 (1)

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