Resistance Exercise in Hemodialysis Patients

NCT06604221 | Not Yet Recruiting

• 1 other identifier: 2024148
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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. 1.Does intradialytic resistance exercise effectively improve the number, frequency, and severity of symptoms in older patients?
2. 2.What adverse events may occur among older dialysis patients during exercise?
3. 3.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.
4. 4.Visit the hospital a monthly for texts and examinations.
5. 5.Keep a diary of the types and frequency of adverse events during and after the exercise sessions.

Conditions

Hemodialysis

Keywords

resistance exercise; hemodialysis; older people

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 30 Seconds Sit To Stand Test

  From enrollment to the end of treatment at 12 weeks

• Short Physical Performance Battery

  From enrollment to the end of treatment at 12 weeks

• Number of participants with abnormal laboratory tests results

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

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.

Behavioral: Resistance exercise intervention; Behavioral: Routine care

control group

ACTIVE COMPARATOR

Routine care

Behavioral: Routine care

Interventions

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.

Also known as: intra dialysis resistance exercise

Resistance Exercise Intervention Group

Routine care BEHAVIORAL

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.

Also known as: Routine care for hemodialysis

Resistance Exercise Intervention Group; control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teng Zeng: lead
• Shengjing Hospital: collaborator

MeSH Terms

Interventions

Renal Dialysis

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Central Study Contacts

Zeng Teng, Graduate Student

CONTACT

+86 13096390520; tengzeng412@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Graduate student

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: October 3, 2024
• Primary Completion: January 3, 2025
• Study Completion: March 3, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share