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Not yet recruiting NCT06604221

Resistance Exercise in Hemodialysis Patients

No phase Interventional Hemodialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resistance exercise intervention, Routine care.
Who it may be relevant to
Registry conditions: Hemodialysis. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Impact of Resistance Exercise on Symptom Burden in Older Patients Undergoing Maintenance Hemodialysis

Overview

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

  • Behavioral Resistance 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.
  • Behavioral Routine 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 rem

Primary outcome measures

  • Dialysis Symptom Index [Time frame: From enrollment to the end of treatment at 12 weeks]
Secondary outcome measures (3)
  • 30 Seconds Sit To Stand Test [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Short Physical Performance Battery [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Number of participants with abnormal laboratory tests results [Time frame: From enrollment to the end of treatment at 12 weeks]

Eligibility criteria

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

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
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06604221 · 2024148

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗