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临床试验/NCT06905236
NCT06905236已完成不适用

Kidney Function Markers in Postmenopausal Obese Women: Response to Aerobic Training

Wissal Abassi1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年9月23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
发起方
入组人数
36
试验地点
1
主要终点
eosinophils

研究概览

简要总结

The goal of this clinical trial is to investigate the impact of a 10-week moderate intensity interval walking training (MIIWT) program on kidney function markers in obese postmenopausal women. The main question it aims to answer is:

Does MIIWT improve kidney function markers in this population? Researchers will compare MIIWT (designed to training group) to non-training intervention (designed to control group) to see if the training program works to improve kidney function markers.

Participants in training group will: perform a 10-week MIIWT program, four sessions per week (5 repetitions of 6-min-walking-test (6MWT) at 60-80% of 6MWTdistance measured at baseline, interspersed by 6-min of active recovery between repetitions). Participants in control group will : not perform any physical training and maintain their usual daily activities.

详细描述

The convergence of the obesity pandemic and the postmenopausal status is likely associated with renal function decline. Regular aerobic training have been shown to prevent adverse health outcomes in obese. The main purpose of this study was to evaluate changes in kidney function markers and white blood cell (WBC) subpopulations in obese postmenopausal women participating in moderate intensity interval walking training (MIIWT). A total of 36 obese postmenopausal women were randomized to MIIWT (CON, n=18) or control group (CON, n=18), four times a week for 10-week. The MIIWT consisted on 5 repetitions of walking for 6-min at 60-80% of the 6-min-walk-test-distance with 6-min of active recovery between repetitions. Before and after the MIIWT, body composition, kidney function markers (serum creatinine [sCr], blood urea nitrogen [BUN], serum uric acid [sUA] and Glomerular Filtration Rate [GFR] and white blood cells (WBC) count and its specific subpopulations (neutrophils [NEU], lymphocytes [LYM], monocytes [MON], eosinophils [EOSI] and basophils [BASO]) were assessed.

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
None

入排标准

年龄范围
50 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •be aged between 50 and 60 years.
  • •be postmenopausal (absence of menses > 12 months).
  • •present a BMI greater than or equal to 30 kg/m
  • •be free of any special diets in the three months prior to the start of the intervention.
  • •have a sedentary lifestyle (exercise less than 2 h/week).

排除标准

  • •Suffering from any cardiovascular/renal/pulmonary/metabolic disease.
  • •Being under menopausal hormone therapy.
  • •Presenting any orthopedic limitations interfering the ability to perform the study intervention.

研究组 & 干预措施

Training group

Experimental

The training group underwent a moderate intensity intermittent walking training at 60% to 80% of the 6- min-walking-test distance, four times a week of 60 min/session for a period of 10 weeks.

干预措施: walking intervention (Behavioral)

Control group

No Intervention

No training intervention was intended for the control group.

结局指标

主要结局

eosinophils

时间窗: At baseline and at week 11(after the ten weeks of the training intervention).

blood concentrations of eosinophils (EOSI) ) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).

basophils

时间窗: At baseline and at week 11(after the ten weeks of the training intervention).

blood concentration of basophils (BASO) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).

serum creatinine

时间窗: At baseline and at week 11(after the ten weeks of the training intervention).

serum concentrations of creatinine (sCr) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).

blood urea nitrogen

时间窗: At baseline and at week 11(after the ten weeks of the training intervention).

serum concentrations of blood urea nitrogen (BUN) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).

serum uric acid

时间窗: At baseline and at week 11(after the ten weeks of the training intervention).

serum concentrations of uric acid (sUA) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).

glomerular Filtration Rate

时间窗: At baseline and at week 11(after the ten weeks of the training intervention).

the glomerular Filtration Rate (GFR) has been computed using the Cockcroft formula, as follows: GFR (mL/min) = \[(140 - age) × weight ×0.85\]/(sCr× 72).

white blood cells count

时间窗: At baseline and at week 11(after the ten weeks of the training intervention).

blood concentration of white blood cells (WBC) count were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany)

neutrophils

时间窗: At baseline and at week 11(after the ten weeks of the training intervention).

blood concentration of neutrophils (NEU) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).

lymphocytes

时间窗: At baseline and at week 11(after the ten weeks of the training intervention).

blood concentrations of lymphocytes (LYM) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).

monocytes

时间窗: At baseline and at week 11(after the ten weeks of the training intervention).

blood concentration of monocytes (MON) were collected (5 ml) in test tubes containing EDTA and analyzed using an automated cell counter (XN450; Sysmex, Norderstedt, Germany).

次要结局

  • Body composition(At baseline and after ten weeks of the training intervention.)
  • 6 min walking test(At baseline and after ten weeks of the training intervention.)

研究者

发起方
Wissal Abassi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wissal Abassi

Principal Investigator

High Institute of Sports and Physical Education of Kef

研究点 (1)

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