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
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
- 否
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
Exercise Group, 6- month combined aerobic and strength exercise
干预措施: EXERCISE INTERVENTION (Other)
GROUP B: CONTROL GROUP
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
Evangelia Kouidi
Professor of Sports Medicine
Aristotle University Of Thessaloniki
