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临床试验/NCT07152158
NCT07152158进行中(未招募)不适用

Effect of Multicomponent Training Combined With Multi-professional Intervention on Health Status in Hypertensive and Normotensive Older Women

Universidad Católica del Maule2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2025年9月17日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
63
试验地点
2
主要终点
Biomarkers analyses

研究概览

简要总结

Objective: The objective of this study was to analyze the effects of multicomponent training (MCT) combined with multidisciplinary intervention (nutritional and psychoeducation) on body composition, biochemical markers, and physical performance in hypertensive and normotensive older women. Methods: This longitudinal study included 40 hypertensive and normotensive older women. These older women performed MCT for 36 weeks, during which parameters associated with health status were evaluated (body composition: body fat, fat-free mass; cardiovascular variables: systolic blood pressure (SPBP), diastolic blood pressure (DBP); biochemical markers: glucose, LDL-cholesterol, HDL-cholesterol, total cholesterol, triglycerides; physical performance: arm curl, maximal isometric handgrip strength (MIHS), 30-second chair stand, 6-meter walking test (6MWT), and Timed Up and Go (TUG)). at four time points: baseline (T0), 12 weeks (T1), 24 weeks (T2), and 36 weeks (T3). A two-way mixed analysis of variance with repeated measures was performed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Aged 60 years or older and medical clearance to engage in physical exercise
  • Those who demonstrated the capacity to comprehend and carry out instructions in a contextualized way through basic directives;
  • Those who were independent, as indicated by a score of at least 43 points on the Chilean Ministry of Health's Preventive Medicine Exam for the Older People
  • Those who were able to meet the intervention's attendance requirement of at least 85%.

排除标准

  • Diagnosed with debilitating neurological disorders (e.g., Alzheimer's disease or Parkinson's disease)
  • Older people with contraindications to physical exercise, and those with cardiac arrhythmias.

结局指标

主要结局

Biomarkers analyses

时间窗: 36 weeks

The blood collection procedures followed the guidelines of the Clinical Laboratory Standards Institute . The participants were previously instructed to prepare accordingly for the collections which were conducted at the Clinical Analysis Laboratory of the Institution's facilities. After the blood was drawn, they were advised to apply pressure to the puncture site to prevent bruising. The blood samples were distributed into the following tubes: Vacuplast® collection tubes, tubes containing the anticoagulant ethylenediaminetetraacetic acid (EDTA) K2, and tubes with fluoride/EDTA anticoagulant.

Anthropometry

时间窗: 36 weeks

The standing height of the participants was measured via a stadiometer (Welmy R - 110®, Santa Bárbara D'Oeste, São Paulo, Brazil) attached to a scale with a maximum capacity of 2.2 meters and an accuracy of 0.1 cm.

Physical performance TUG

时间窗: 36 weeks

Following earlier suggestions, the TUG test was conducted. The person must get out of an arm-supported chair, cross a three-meter aisle, turn around, and return to the chair. They must perform three trials and record the best one in seconds. A pair of evaluators measured the time using single-beam photocells (Brower Timing System, Draper, UT, USA), and the best of three trials was utilized for statistical analysis

30-second chair stand

时间窗: 36 weeks

Three repetitions were evaluated to retrieve the best performance executed on the 30-chair stand test. Its purpose was to evaluate the lower limbs' muscle strength, and it is executed while seated in a chair, with the arms resting across the chest, for 30 s.

Arm curl Test

时间窗: 36 weeks

In the arm-curl test, participants sat on a chair and were asked to flex the elbow of their stronger arm as many times as possible in 30 seconds while holding a 1-kg dumbbell. Participants were instructed to maintain a normal breathing pattern and keep their elbow at their side during the entire test. A single repetition consisted of full elbow flexion from maximal extension

MIHS

时间窗: 36 weeks

Previous studies have recommended the use of MIHS testing. The most suitable testing position was determined to be seated, with the forearm and wrist maintained in a neutral position, the elbow flexed at 90◦ and kept close to the torso, the spine properly aligned, and the shoulder relaxed in a neutral position. A handheld dynamometer (Jamar®, PLUS+, Sammons Preston, Patterson Medical, Warrenville, IL, USA) was used to perform the measurements. To accommodate varying hand sizes and ensure effective engagement of the metacarpophalangeal and interphalangeal joints, the dynamometer was set to the first position, allowing contact between the thumb and the proximal phalanx of the index finger. Participants were given a 120 s rest period between each of the three repetitions per hand.

6MWT

时间窗: 36 weeks

Heart rate (HR) was recorded at rest and at the end of each minute during the 6MWT using a lightweight telemetric HR monitor. Oxygen saturation (SpO2) was recorded before and after completing the 6MWT using an oximeter and a finger sensor. At the end of the test, distance was measured and, where appropriate, leg fatigue was assessed using a modified Borg scale from 0 to 10.

body composition

时间窗: 36 weeks

Body composition was assessed via a tetrapolar bioelectrical impedance analyzer (InBody 570®, Bio space Co. Ltd., Seoul, South Korea), with a capacity of 250 kg and an accuracy of 100 g, following the manufacturer's instructions and establishing recommendations to increase precision and reliability. The following variables were assessed: body weight (kg), BFP, FFM (kg), and body mass index (BMI, kg/m²).

次要结局

未报告次要终点

研究者

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

Pablo Valdés-Badilla

Principal Investigator

Universidad Católica del Maule

研究点 (2)

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