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| Name | Class |
|---|---|
| Shengjing Hospital | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistance Exercise Intervention Group | Experimental | Resistance exercise intervention plan, 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. |
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| control group | Active Comparator | Routine care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance exercise intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dialysis Symptom Index | 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. | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 30 Seconds Sit To Stand Test | 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. |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zeng Teng, Graduate Student | Contact | +86 13096390520 | tengzeng412@gmail.com |
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| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
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| Routine care | Behavioral | 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. |
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| From enrollment to the end of treatment at 12 weeks |
| Short Physical Performance Battery | (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. | From enrollment to the end of treatment at 12 weeks |
| Number of participants with abnormal laboratory tests results | blood urea, blood creatinine, dialysis adequacy (Kt/V), hemoglobin, neutrophil-to-lymphocyte ratio, serum albumin, standardized protein catabolic rate, C-reactive protein, inflammatory factors | From enrollment to the end of treatment at 12 weeks |