Intrahospital Exercise Program in Hemodialysis Patients: Impact on Sarcopenia Markers, Sleep Quality, and Quality of Life.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- > Change in Upper Limb Muscle Strength measured by Handgrip Dynamometry.
研究概览
简要总结
Sarcopenia (the loss of muscle mass, strength, and function) is highly prevalent in patients with Chronic Kidney Disease (CKD) undergoing hemodialysis, significantly increasing the risk of falls, frailty, and mortality. Despite its impact, there is a lack of evidence regarding the effectiveness of exercise programs specifically designed to address sarcopenia under the latest international diagnostic criteria (EWGSOP2) in older renal patients.
The primary objective of this randomized controlled clinical trial is to evaluate the effects of a 12-week supervised intrahospital exercise program on muscle mass, strength, and physical performance in hemodialysis patients over 40 years of age. Additionally, the study aims to analyze how this intervention influences sleep quality-often disrupted in this population-and overall health-related quality of life.
Participants will be randomly assigned to either an Intervention Group, which will perform personalized strength and aerobic exercises during the first 90 minutes of their dialysis sessions, or a Control Group, receiving standard care. Evaluations will be conducted at three points: baseline (pre-randomization), at 12 weeks (post-intervention).
The investigators hypothesize that integrating physical exercise into the routine clinical care of hemodialysis patients will improve sarcopenia markers and sleep patterns, leading to greater functional independence and better clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects currently enrolled in a Chronic Hemodialysis Unit.
- •Patients who have been on hemodialysis treatment for more than 3 months.
- •Subjects aged 40 years or older.
- •Hemoglobin levels greater than 10 mg/dl.
- •Ability to perform physical fitness assessment tests or dynamometry.
- •Willingness and ability to provide signed informed consent
排除标准
- •Presence of intradialytic instability.
- •Medical conditions where exercise is contraindicated: active infectious process, neoplasms, uncontrolled arrhythmias, or left ventricular dysfunction (EF < 35%).
- •Musculoskeletal or respiratory alterations that worsen with exercise.
- •Lower limb amputation without a prosthesis.
- •Cerebrovascular disease (stroke with sequelae or transient ischemic attacks within the previous 6 weeks).
- •Uncontrolled hypertension (Systolic BP > 200 mmHg or Diastolic BP > 120 mmHg).
- •Unstable angina (at rest or during exercise) or history of coronary bypass/ischemic heart disease within the previous 6 weeks.
- •Diabetes mellitus with severe decompensation (blood glucose > 300 mg/dl).
- •Dialysis-related hypotension (mean blood pressure < 90/70 mmHg).
- •Psychiatric or cognitive alterations that prevent collaboration with muscle training programs.
- •Presence of an arteriovenous fistula in a lower limb.
- •Motor neurological injury causing dysfunction that prevents the application of the strength protocol.
- •Hospitalization within the 3 months prior to the study.
- •Lack of cooperation (defined as failing to attend more than 25% of sessions) or inability to understand the treatment.
研究组 & 干预措施
No Intervention : Control group
Experimental: Intervention Group
Intradialytic exercise program (strength and aerobic) 3 times weekly for 3 months.
干预措施: Intradialytic Personalized Exercise Program. (Behavioral)
结局指标
主要结局
> Change in Upper Limb Muscle Strength measured by Handgrip Dynamometry.
时间窗: > Baseline, 12 weeks (post-intervention)
\> Muscle strength is assessed using a CAMRYR electronic dynamometer (Model EH101). The participant is in a standing position with the arm extended and parallel to the body. Maximum grip strength is measured over 3 seconds. Two attempts are made for each arm, and the highest value from the dominant arm (measured in kilograms) is recorded.
Change in Lower Limb Muscle Strength measured by the 5-Times Sit-to-Stand Test (STS5).
时间窗: Baseline, 12 weeks (post-intervention)
The STS5 test measures the time (in seconds) required for the patient to rise from a chair 5 consecutive times without arm support. It is a proxy for lower extremity muscle strength and power. A decrease in the time taken indicates an improvement in muscle function.
Change in Appendicular Skeletal Muscle Mass (ASMM) measured by Bioelectrical Impedance Analysis (BIA).
时间窗: Baseline, 12 weeks (post-intervention)
Assessment of body composition and muscle mass using a portable BIA device. This method provides a validated estimate of muscle mass in both ambulatory and bedridden patients. The study focuses on the Appendicular Skeletal Muscle Mass (ASMM), which is essential for confirming a diagnosis of sarcopenia according to EWGSOP2 criteria. Higher values reflect greater muscle mass.
Change in Physical Performance measured by the Short Physical Performance Battery (SPPB).
时间窗: Baseline, 12 weeks (post-intervention)
The SPPB is a composite score (0 to 12 points) evaluating balance, gait speed (4 meters), and the sit-to-stand test. A total score of 8 or less identifies patients with severe sarcopenia or high risk of frailty. Higher scores indicate better physical performance.
Change in Sleep Quality measured by the Pittsburgh Sleep Quality Index (PSQI).
时间窗: Baseline, 12 weeks (post-intervention)
A self-administered questionnaire that assesses sleep quality over a 1-month time interval. It consists of 19 individual items, creating 7 components that yield one global score (range 0 to 21). Lower scores denote better sleep quality.
次要结局
- > Change in Sarcopenia-related Quality of Life measured by the SarQoL® Questionnaire.(> Baseline, 12 weeks (post-intervention))
- Objective Sleep Assessment via Wrist-worn Accelerometry (Actigraph).(Baseline, 12 weeks (post-intervention))
- Change in Fat Mass Percentage measured by Bioelectrical Impedance Analysis (BIA).(Baseline, 12 weeks (post-intervention).)
- Change in Total Body Water (TBW) Percentage measured by Bioelectrical Impedance Analysis (BIA).(Baseline, 12 weeks (post-intervention).)
研究者
José Ignacio Recio Rodriguez
Phd, Associate profesor
University of Salamanca