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临床试验/NCT07427264
NCT07427264进行中(未招募)不适用

The Effect of a Mixed-type Intradialytic Exercise Training Program on Body Composition, Functional Capacity, and Muscle Oxygenation of the Upper and Lower Limbs in Hemodialysis Patients

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Clinical and demographic characteristics

研究概览

简要总结

Chronic kidney disease (CKD) is a progressive clinical condition that affects a growing number of people worldwide. While advances in haemodialysis techniques have led to notable improvements in survival rates and the quality of life (QoL) of patients with CKD (PwCKD), significant complications persist, primarily associated with chronic uremia. These include skeletal muscle atrophy, reduced muscular strength and diminished functional capacity.

Recent studies support the role of systematic exercise as a non-pharmacological strategy to reduce issues and improve musculoskeletal function among haemodialysis patients. Specifically, intradialytic exercise gained ground due to its efficiency in time utilization and elimination of transport burden. Nevertheless, most of the intradialytic exercise programs implement aerobic exercise and there is a lack of studies investigating combined strength and aerobic exercise modalities, which may offer more comprehensive physiological benefits.

The aim of the randomized controlled trial (RCT) is to examine whether a 6-month combined aerobic and resistance exercise program, implemented during haemodialysis sessions, could affect body composition, muscle oxygenation of the lower and upper extremities, and functional capacity of patients that underwent haemodialysis.

Forty patients will be randomly allocated into two groups: Group A (Exercise Group) will undergo 3 sessions per week of an intradialytic exercise program for 6 months and Group B (Control Group) will receive the usual care without participating in organized exercise programs.

Prior to the group random allocation, part of our assessments at baseline and after 6 (Evaluation A') will include demographics and clinical history, body composition analysis via bioelectrical impedance analysis, muscle oxygenation monitoring of the vastus lateralis and biceps brachii muscles at rest and during exercise using NIRS technology. Functional capacity will be assessed though validated tests: Six- minute walk test (6MWT), 30 second sit-to-stand test, 10 repetitions sit-to-stand test, handgrip strength, 4- meter gait speed test. Additionally, we will use questionnaires assessing physical activity (IPAQ), depression (BDI), stress (GAD-7) and the QoL (KDQOL-SFTM) of people that underwent dialysis.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 and <80 yrs, either gender
  • Confirmed diagnosis
  • Patients undergoing maintenance hemodialysis therapy for at least 6 months.

排除标准

  • Acute Myocardial Infraction
  • Severe valvular diseases
  • Potentially malignant arrhythmias
  • Unstable angina
  • Hospitalized patients
  • Uncontrolled diabetes melitus
  • Uncontrolled hypertension
  • Νeurological, or orthopedic limitations/non- ambulant status
  • Cognitive or psychiatric disorders
  • Poor regulation of comorbidities
  • Already participating in organized exercise programs
  • Current pregnancy
  • Inability/unwillingness to give informed consent

研究组 & 干预措施

GROUP A: EXERCISE GROUP

Experimental

Exercise Group, 6- month combined aerobic and strength exercise

干预措施: EXERCISE INTERVENTION (Other)

GROUP B: CONTROL GROUP

No Intervention

Control Group, 6- month without participating in organized exercise activities, no intervention

结局指标

主要结局

Clinical and demographic characteristics

时间窗: Baseline

Clinical and demographic characteristics

时间窗: 6-month

Muscle oxygenation Assessment-MOXY

时间窗: Baseline

Measurement of vastus lateralis and biceps brachii muscle oxygenation at rest and during exercise using near-infrared spectroscopy (NIRS) devices (Moxy 1408, Fortiori Design LLC, Minnesota, USA; Moxy 2136, Idiag AG, Fehraltorf, Switzerland).

Muscle Oxygenation Assessment-MOXY

时间窗: 6-months

Measurement of vastus lateralis and biceps brachii muscle oxygenation at rest and during exercise using near-infrared spectroscopy (NIRS) devices (Moxy 1408, Fortiori Design LLC, Minnesota, USA; Moxy 2136, Idiag AG, Fehraltorf, Switzerland).

Body composition analysis

时间窗: Baseline

Bioelectrical impedance analysis (Bodystat QuadScan 4000).

Body composition analysis

时间窗: 6-month

Bioelectrical impedance analysis (Bodystat QuadScan 4000).

Six minute walk test

时间窗: Baseline

Aerobic capacity

Six minute walk test

时间窗: 6-month

Aerobic capacity

JAMAR SMART Hand Dynamometer

时间窗: Baseline

Handgrip Strength

JAMAR SMART Hand Dynamometer

时间窗: 6- month

Handgrip Strength

30-second Sit-to-Stand Test

时间窗: Baseline

Lower limb functional capacity

30-second Sit-to-Stand Test

时间窗: 6- month

Lower limb functional capacity

Five-Repetition Sit-to-Stand Test (5STS)

时间窗: Baseline

Lower limb functional capacity

Five-Repetition Sit-to-Stand Test (5STS)

时间窗: 6- month

Lower limb functional capacity

4-Meter Gait Speed Test

时间窗: Baseline

4-Meter Gait Speed Test

时间窗: 6- month

International Physical Activity Questionnaire (IPAQ).

时间窗: Baseline

Assessment of Physical Activity Levels

International Physical Activity Questionnaire (IPAQ).

时间窗: 6- month

Assessment of Physical Activity Levels

Beck Depression Inventory (BDI)

时间窗: Baseline

Assessment of depressive symptoms

Beck Depression Inventory (BDI)

时间窗: 6- month

Assessment of depressive symptoms

Generalized Anxiety Disorder-7 scale (GAD-7).

时间窗: Baseline

Assessment of anxiety levels

Generalized Anxiety Disorder-7 scale (GAD-7).

时间窗: 6- month

Assessment of anxiety levels

Kidney Disease Quality of Life Short Form (KDQOL-SF™)

时间窗: Baseline

Assessment of Quality of Life

Kidney Disease Quality of Life Short Form (KDQOL-SF™)

时间窗: 6- month

Assessment of Quality of Life

Baseline leg dynamometer

时间窗: Baseline

Baseline leg dynamometer

时间窗: 6- months

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

Evangelia Kouidi

Professor of Sports Medicine

Aristotle University Of Thessaloniki

研究点 (1)

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