Clinical trial NCT06604221: Resistance Exercise in Hemodialysis Patients
Official title: The Impact of Resistance Exercise on Symptom Burden in Older Patients Undergoing Maintenance Hemodialysis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemodialysis
Keywords: resistance exercise
hemodialysis
older people
Lead sponsor: China Medical University, China
Sponsor class: OTHER
Collaborators: name: Shengjing Hospital
First posted: 2024-09-19
Enrollment: 54
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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) \&amp;lt; 90g/L, Albumin (Alb) ≤ 32g/L Participation in other exercise or pharmacological interventions in the past 6 months

Primary outcomes:
measure: Dialysis Symptom Index
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: 30 Seconds Sit To Stand Test
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Short Physical Performance Battery
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Number of participants with abnormal laboratory tests results
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
Study officials:
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