Exercise During Hemodialysis: Impact on Sarcopenia and Sleep Quality

Official title

Intrahospital Exercise Program in Hemodialysis Patients: Impact on Sarcopenia Markers, Sleep Quality, and Quality of Life.

Overview

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.

Interventions

• Behavioral Intradialytic Personalized Exercise Program.
  Personalized intradialytic exercise program performed during the first 30 minutes of the hemodialysis session once the patient is hemodynamically stable. The intervention lasts 12 weeks with 2-3 sessions per week, supervised by physiotherapists. Each session (max. 60 min) includes: 1) Respiratory and joint mobility warm-up; 2) Strength training for lower limbs (hip flexors, extensors, abduction/adduction, and ankle movements) using elastic bands, weighted ankle straps, foam balls, and Pilates ri

Primary outcome measures

• > Change in Upper Limb Muscle Strength measured by Handgrip Dynamometry. [Time frame: > Baseline, 12 weeks (post-intervention)]
• Change in Lower Limb Muscle Strength measured by the 5-Times Sit-to-Stand Test (STS5). [Time frame: Baseline, 12 weeks (post-intervention)]
• Change in Appendicular Skeletal Muscle Mass (ASMM) measured by Bioelectrical Impedance Analysis (BIA). [Time frame: Baseline, 12 weeks (post-intervention)]
• Change in Physical Performance measured by the Short Physical Performance Battery (SPPB). [Time frame: Baseline, 12 weeks (post-intervention)]
• Change in Sleep Quality measured by the Pittsburgh Sleep Quality Index (PSQI). [Time frame: Baseline, 12 weeks (post-intervention)]

Secondary outcome measures (4)

• > Change in Sarcopenia-related Quality of Life measured by the SarQoL® Questionnaire. [Time frame: > Baseline, 12 weeks (post-intervention)]
• Objective Sleep Assessment via Wrist-worn Accelerometry (Actigraph). [Time frame: Baseline, 12 weeks (post-intervention)]
• Change in Fat Mass Percentage measured by Bioelectrical Impedance Analysis (BIA). [Time frame: Baseline, 12 weeks (post-intervention).]
• Change in Total Body Water (TBW) Percentage measured by Bioelectrical Impedance Analysis (BIA). [Time frame: Baseline, 12 weeks (post-intervention).]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Universidad de Salamanca — Salamanca

Identifiers

NCT: NCT07447375 · GRS 3142/A1/2024 · GRS 3142/A1/2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗