The Effect of Active Exercise on Maintenance Haemodialysis Patients

Effect of Active Exercise on Nutritional and Inflammatory Status, Muscle Metabolism and Cardiovascular Events in Maintenance Haemodialysis Patients

The goal of this clinical trial is to discuss the effects of physical activity on nutrition, inflammation, muscle metabolism, and the occurrence of cardiovascular and cerebrovascular events in patients with maintenance haemodialysis. The main question it aims to answer is: can exercise improve nutritional and inflammatory status, enhance muscle strength, and reduce the incidence of cardiovascular and cerebrovascular events in patients with maintenance haemodialysis.

Researchers will compared active exercise group to conventional treatment group to see the impact of exercise on maintenance haemodialysis patients.

Participants will:

Choose low-intensity aerobic exercise workouts such as walking (no less than 8,000 steps per day) or jogging, swimming, Tai Chi, etc., according to their individual conditions, for no less than 30 minutes at a time, at least 3 times per week, and the intensity of the exercise should be based on an RPE score of 12 to 16.

Study Overview

• Status: Recruiting
• Conditions: Renal Dialysis
• Intervention / Treatment: Behavioral: exercise

Detailed Description

RPE: Rating of Perceived Exertion. RPE scores of 12 to 16 indicate the need for increased respiratory rate and depth during exercise, the ability to engage in conversational exchanges, light sweating, and a feeling of slight fatigue without reaching a state of exhaustion.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • Recruiting
      • The First Affiliated Hospital of Chongqing Medical University
      • Contact: Yunfeng Xia, Dr.; Phone Number: 86-23-89012256; Email: xyf0920@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• MHD more than 3 months, 3 times per week, 3-4h each time;
• Urea clearance index (Kt/V) >1.2;
• Stable condition, no serious infection, tumour and cardiovascular disease;
• Willing to join the study and sign the informed consent form.

Exclusion Criteria:

• Combined with serious heart and lung disease: such as repeated heart failure, severe arrhythmia, unstable angina pectoris, severe pericardial effusion, severe heart valve disease, hypertrophic cardiomyopathy, aortic coarctation, severe emphysema, pulmonary heart disease, severe pulmonary hypertension (average pressure of the pulmonary artery > 55mmHg), etc.;
• Combined with chronic joints, muscles, or vascular disease can not be or is not suitable for regular exercise, such as cerebrovascular disease; combined chronic joint, muscle or vascular disease can not or are not suitable for regular exercise, such as cerebrovascular disease sequelae, serious lower limb joint damage, severe myopathy, deep vein thrombosis, etc.;
• unwilling to cooperate with the movement of people

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise group; patients were asked to choose walking (no less than 8000 steps per day) or low-intensity aerobic exercise such as jogging, swimming, Tai Chi, etc., according to their own conditions, for no less than 30 minutes each time, at least 3 times per week, and the intensity of the exercise was determined by the need to increase the frequency and depth of breathing during the exercise, and it was appropriate to feel slightly tired but not exhausted (RPE score 12-16). Exercise intensity should be at least 3 times a week, and the exercise intensity should be at a level that requires an increase in breathing rate and depth, allowing for dialogue and communication, slight sweating, and a feeling of being slightly tired but not exhausted (RPE score of 12 to 16).	Behavioral: exercise; such as walking, jogging, swimming, Tai Chi, etc. It needs to be at a certain frequency and intensity
No Intervention: Control group; only receive conventional MHD treatment, no requirement for exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mid-upper arm circumference of the non-internal fistula side（AC）	Measure the circumference of the non-internal fistula at the midpoint of the upper arm using a soft tape measure, in centimetres	Baseline and half year, 1 year
triceps skin-fold thickness of the non-internal fistula side（TSF）	Measurement of the skinfold at the midpoint of the upper arm on the non-internal fistula side by using a skinfold thickness gauge, in centimetres	Baseline and half year, 1 year
upper arm muscle circumference of the non-internal fistula side（AMC）	AMC（cm）= AC(cm) - 3.14 x TSF（cm）	Baseline and half year, 1 year
calf circumference	Measure the calf circumference using a soft tape measure, in centimetres	Baseline and half year, 1 year
grip strength	Using a grip strength meter, with the patient seated and gripping the handle firmly with the palm of the non-internal fistulae side, measure twice and record the maximum grip strength value	Baseline and half year, 1 year
Incidence of cardiovascular and cerebrovascular events	Cardiovascular events include: heart failure episodes, sustained arrhythmias, myocardial infarction, and cerebrovascular events include: cerebral haemorrhage, cerebral infarction, transient ischaemic attack.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prealbumin	laboratory measurement indicators:prealbumin(g/L)	Baseline and half year, 1 year
albumin	laboratory measurement indicators:albumin(g/L)	Baseline and half year, 1 year
haemoglobin	laboratory measurement indicators:haemoglobin(g/L)	Baseline and half year, 1 year
blood lipids	laboratory measurement indicators:triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein	Baseline and half year, 1 year
c-reactive protein	laboratory measurement indicators:c-reactive protein(mg/L)	Baseline and half year, 1 year

Collaborators and Investigators

• Sponsor: Yunfeng Xia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Inflammation; Exercise; Nutrition; Muscular Atrophy
• Other Study ID Numbers: First ChongQing MU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No