Resistance Exercise in Hemodialysis Patients (REHDP)

Teng Zeng

Status: Not yet enrolling

Conditions: Hemodialysis

Treatments: Behavioral: Resistance exercise intervention; Behavioral: Routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT06604221

2024148

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Resistance Exercise Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Routine care

Behavioral: Resistance exercise intervention

control group

Active Comparator group

Description:

Routine care

Treatment:

Behavioral: Routine care