NCT Number: NCT06604221
The goal of this clinical trial is to learn if an intradialytic resistance exercise intervention works to reduce the symptom burden in older maintenance hemodialysis patients. It will also learn about safety of the intradialytic resistance exercise intervention program. The main questions it aims to answer are:
1. Does intradialytic resistance exercise effectively improve the number, frequency, and severity of symptoms in older patients? 2. What adverse events may occur among older dialysis patients during exercise?
Researchers will compare older dialysis patients who undergo the intradialytic resistance exercise intervention with those receiving standard care to observe whether resistance exercise can improve symptom burden.
Participants will:
1. Take an intradialytic resistance exercise intervention program developed through joint decision-making by rehabilitation experts, dialysis center physicians, nurses, and patients, conducted three times a week for 20 minutes each session, over a duration of three months. 2. Visit the hospital a monthly for texts and examinations. 3. Keep a diary of the types and frequency of adverse events during and after the exercise sessions.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age 60 years and above Stable on dialysis for ≥3 months Able to walk independently, no physical disability, and muscle strength ≥ Grade III Capable of understanding and complying with the requirements of this study Voluntarily signed an informed consent form
Exclusion criteria
Severe cardiovascular, cerebrovascular, respiratory, or neurological diseases, or other conditions that impair physical ability to exercise Serious infections, bleeding, trauma, or other conditions affecting physical status within the last 3 months Severe mental disorders or cognitive impairments Abnormal blood pressure (pre-dialysis systolic pressure ≥180mmHg, diastolic pressure ≥100mmHg) Hemoglobin (Hb) < 90g/L, Albumin (Alb) ≤ 32g/L Participation in other exercise or pharmacological interventions in the past 6 months
The exercise prescription, developed through expert meetings and integrated review summaries, consists of 27 items including: participant preparation, team preparation, exercise prescription FITT-VP, process monitoring, discontinuation criteria, termination criteria, recovery methods, outcome measures, and special considerations.
Other names: intra dialysis resistance exercise
1.Pre-dialysis Assessment:
（1）Monitoring: Continuous vital signs and machine settings monitoring. （2）Fluid Management: Control fluid removal based on pre-dialysis weight. 3.Post-dialysis Care:
（1）Diet: Educate on dietary restrictions (potassium, phosphorus, fluids). （2）Medications: Advise on medication adjustments. 5.Psychosocial Support:
（1）Provide emotional support and counseling.
Other names: Routine care for hemodialysis
Time frame: From enrollment to the end of treatment at 12 weeks
Kidney failure-related symptoms were assessed every month using the dialysis symptom index (DSI), a previously validated questionnaire Through this questionnaire, patients indicated the presence of 30 symptoms in the past month, resulting in a total sum score for symptom number ranging from 0 to 30. Additionally, for each symptom present, patients rated symptom burden on a five-point Likert scale, ranging from one for "not at all" to five for "very much" burdensome. Absent symptoms were assigned a score of zero, resulting in an overall symptom burden score ranging from zero to 150, with higher scores indicating larger burden.
Time frame: From enrollment to the end of treatment at 12 weeks
A chair with a hard seat whose floor-to-seat height was 48 cm was stabilized by placing it against a wall. After a researcher explained the requirements and precautions to the participant, the participant was asked to sit with his or her feet exactly flat on the ground and his or her upper limbs folded across his or her chest and then to stand up all the way and sit down again without using his or her arms. And the participant was asked to repeat as many of the sit-to-stand actions as possible in 30 seconds, and the maximum number completed was recorded.
Higher scores mean a better outcome.
Time frame: From enrollment to the end of treatment at 12 weeks
(SPPB) which consists of 3 timed components: 1) a 4-meter usual pace walk, 2) a five-repetition chair stand without using one's arms, and 3) a progressive test of standing balance. Times from each component were scored from 0-4, with higher scores corresponding to better performance.
Time frame: From enrollment to the end of treatment at 12 weeks
blood urea, blood creatinine, dialysis adequacy (Kt/V), hemoglobin, neutrophil-to-lymphocyte ratio, serum albumin, standardized protein catabolic rate, C-reactive protein, inflammatory factors
Contact information is provided by the study sponsor or research team.
Teng Zeng
Other
The Impact of Resistance Exercise on Symptom Burden in Older Patients Undergoing Maintenance Hemodialysis
Acronym: REHDP
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