Resistance Exercise in Hemodialysis Patients (REHDP)

September 17, 2024 updated by: Teng Zeng

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resistance Exercise Intervention Group
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.
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.
Other Names:
  • intra dialysis resistance exercise
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 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.

Other Names:
  • Routine care for hemodialysis
Active Comparator: control group
Routine care
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 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.

Other Names:
  • Routine care for hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dialysis Symptom Index
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.
From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 Seconds Sit To Stand Test
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.
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
(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
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
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teng Zeng

Collaborators

Shengjing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 3, 2024

Primary Completion (Estimated)

January 3, 2025

Study Completion (Estimated)

March 3, 2025

Study Registration Dates

First Submitted

September 2, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

  1. Privacy Concerns: To protect participant privacy and confidentiality, given the sensitive nature of the data.
  2. Research Integrity: To maintain the integrity of the research and prevent potential misuse of the data outside the specific study objectives.
  3. Personal Decision: To retain control over data usage and ensure adherence to ethical standards and research protocols established for this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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