Resistance Exercise in Hemodialysis Patients

NCT ID: NCT06604221

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-03
• Study Completion Date: 2025-03-03

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.

Conditions

Hemodialysis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Resistance exercise intervention

Intervention Type: 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.

Routine care

Intervention Type: 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.

control group

Routine care

Group Type: ACTIVE_COMPARATOR

Routine care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

intra dialysis resistance exercise; Routine care for hemodialysis

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: collaborator

Teng Zeng

OTHER

Sponsor Role: lead

Responsible Party

Teng Zeng

Graduate student

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Zeng Teng, Graduate Student

Role: CONTACT

tengzeng412@gmail.com

+86 13096390520

Other Identifiers

2024148

Identifier Type: -

Identifier Source: org_study_id