Investigation of the Effects of Intradialytic Combined Exercises on Dialysis Parameters and Muscle Oxygenation in Sarcopenic Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Muscle Oxygen Saturation (SmO₂, %)
研究概览
简要总结
This randomized controlled trial will evaluate the effects of a 12-week intradialytic combined exercise program, consisting of aerobic and resistance training, in patients with stage 5 chronic kidney disease receiving maintenance hemodialysis. Sarcopenia, a progressive loss of muscle mass and strength, is common in this population due to chronic disease burden and the sedentary nature of dialysis sessions. The intervention group will perform structured exercise three times per week during the first two hours of dialysis, while the control group will continue routine dialysis care without exercise.
The primary aim is to investigate whether intradialytic exercise can improve dialysis adequacy and muscle oxygenation, and reduce sarcopenia severity. Secondary objectives include evaluating changes in physical performance, muscle strength, fatigue levels, and health-related quality of life. Approximately 40 participants will be randomized into intervention and control groups. Outcomes will be assessed through clinical measurements, functional tests, and patient-reported questionnaires before and after the intervention period.
详细描述
Sarcopenia is a progressive loss of skeletal muscle mass and strength, associated with physical disability, poor quality of life, and increased mortality risk. Although commonly linked to aging, sarcopenia may also develop as a secondary condition in patients with chronic kidney disease (CKD) due to malnutrition, low physical activity, or treatment-related catabolism. In individuals undergoing hemodialysis, protein catabolism, inflammation, and nutrient loss are accelerated, further contributing to sarcopenia. Prolonged dialysis sessions also enforce sedentary behavior, exacerbating physical decline.
Exercise interventions have been shown to delay sarcopenia progression, improve functional capacity, and support survival. Intradialytic exercise, performed during dialysis sessions, offers practical advantages as it is time-efficient, conducted under medical supervision, and associated with better adherence compared to exercise outside dialysis. Combined programs involving both aerobic and resistance training are particularly effective in improving dialysis adequacy, reducing fatigue, and supporting muscle maintenance.
Muscle oxygenation plays an important role in sarcopenia. Factors such as oxidative stress, mitochondrial dysfunction, and impaired circulation can reduce oxygen delivery and utilization, leading to muscle weakness and atrophy. Hemodialysis itself alters microcirculation and oxygenation, negatively affecting muscle recovery. Near-infrared spectroscopy (NIRS) enables non-invasive monitoring of muscle oxygenation and has demonstrated that exercise interventions can improve tissue oxygenation parameters.
This randomized controlled trial will investigate the effects of a 12-week intradialytic combined exercise program-including aerobic and resistance training-on dialysis adequacy, muscle oxygenation, and sarcopenia severity in patients with CKD undergoing maintenance hemodialysis. Secondary outcomes will include physical performance, fatigue, and health-related quality of life.
The study will be conducted at Kadıköy Dialife Ata Dialysis Center in Istanbul, Turkey. A total of 40 participants aged 18-65 with stage 5 CKD on maintenance hemodialysis for at least one year, and diagnosed with sarcopenia according to EWGSOP2 criteria, will be enrolled. Participants will be randomly assigned to either an exercise group or a control group.
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
- Single (Participant)
盲法说明
Participants were aware of their group assignment (exercise or routine care) due to the nature of the intervention. Neither researchers nor outcome assessors were masked.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Diagnosed with stage 5 chronic kidney disease (end-stage renal disease) according to GFR, undergoing maintenance hemodialysis for at least 1 year
- •Diagnosed with sarcopenia based on EWGSOP2 (2018) criteria
- •Able to read and write
- •Cooperative and able to follow instructions
- •Voluntary participation with written informed consent
排除标准
- •Presence of orthopedic or neurological disorders affecting mobility or exercise capacity
- •Uncontrolled diabetes mellitus or uncontrolled hypertension
- •Untreated intradialytic hypotension
- •Heart failure
- •Unstable angina
研究组 & 干预措施
Exercise Group
Participants in this arm will receive a 12-week intradialytic combined exercise program, performed three times per week during the first two hours of hemodialysis. Each session will begin with a 10-minute warm-up and end with a 10-minute cool-down (stretching and breathing exercises).
Aerobic component: Supine cycling using a portable ergometer at 45-70% of maximum heart rate, monitored with pulse oximetry and Borg scale, progressively increased every 1-2 weeks.
Resistance component: Exercises with elastic bands and ankle weights targeting major upper and lower extremity muscle groups (non-fistula arm). Performed in 2 sets of 8-12 repetitions, with progressive loading based on ACSM guidelines.
All sessions will be supervised by trained physiotherapists and dialysis staff to ensure safety and adherence
干预措施: EXERCISE TRAINING WITH OR WITHOUT MEDICATION (Other)
Control Group
Participants in this arm will continue routine hemodialysis care for 12 weeks. In addition, they will receive general recommendations for breathing and posture exercises to be performed outside dialysis sessions. These exercises will not be structured or supervised, and no additional training program will be provided during dialysis
结局指标
主要结局
Muscle Oxygen Saturation (SmO₂, %)
时间窗: Baseline and after 12 weeks
Muscle oxygen saturation (SmO₂) will be measured non-invasively using near-infrared spectroscopy (Moxy device) placed over the vastus lateralis muscle. Average SmO₂ values will be recorded at rest, during a 6-minute walk test, and during post-exercise recovery to assess local oxygen delivery and utilization.
Total Hemoglobin Concentration
时间窗: Baseline and after 12 weeks
Total hemoglobin concentration will be measured non-invasively using near-infrared spectroscopy (Moxy device) placed over the vastus lateralis muscle. Values will be recorded at rest, during a 6-minute walk test, and during post-exercise recovery to evaluate local oxygen delivery and utilization.
Dialysis Adequacy - Kt/V
时间窗: Baseline and after 12 weeks
Dialysis adequacy will be assessed using pre- and post-dialysis blood urea nitrogen (BUN) levels. Kt/V will be calculated to evaluate the effectiveness of hemodialysis treatment. Higher values indicate better dialysis efficiency.
Dialysis Adequacy - Urea Reduction Ratio
时间窗: Baseline and after 12 weeks
Dialysis adequacy will be assessed using pre- and post-dialysis blood urea nitrogen (BUN) levels. Urea Reduction Ratio (URR) will be calculated to evaluate the effectiveness of hemodialysis treatment. Higher values indicate better dialysis efficiency.
次要结局
- Handgrip Strength(Baseline)
- Fat-Free Mass Index(Baseline)
- Peripheral Muscle Strength(Baseline and after 12 weeks)
- Six-Minute Walk Test (6MWT)(Baseline and after 12 weeks)
- Short Physical Performance Battery (SPPB)(Baseline and after 12 weeks)
- Fatigue Severity Scale (FSS)(Baseline and after 12 weeks)
- Kidney Disease Quality of Life (KDQOL-36)(Baseline and after 12 weeks)
研究者
Beyza DAL KOYUNCUOĞLU
Research Assistant
Istinye University