Hemodialysis
Conditions
Keywords
resistance exercise, hemodialysis, older people
Brief summary
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.
Interventions
BEHAVIORALResistance exercise intervention
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.
BEHAVIORALRoutine care
1.Pre-dialysis Assessment: 1. Vital Signs: Monitor blood pressure, heart rate, temperature. 2. Access Care: Check the vascular access site for signs of infection and patency. 2.During Dialysis: （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. Observation: Monitor for complications like hypotension, cramps, or bleeding. 2. Weight Check: Weigh post-dialysis to verify fluid removal. 4.Education and Support: （1）Diet: Educate on dietary restrictions (potassium, phosphorus, fluids). （2）Medications: Advise on medication adjustments. 5.Psychosocial Support: （1）Provide emotional support and counseling.
Sponsors
Shengjing Hospital
Teng Zeng
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dialysis Symptom Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30 Seconds Sit To Stand Test | 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. |
| Short Physical Performance Battery | 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. |
| Number of participants with abnormal laboratory tests results | 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 |
Contacts
Primary ContactZeng Teng, Graduate Student
Outcome results
None listed