The Effect of Active Exercise on Maintenance Haemodialysis Patients

NCT ID: NCT06568835

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-07-01

Brief Summary

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.

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.

Conditions

Renal Dialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

exercise

Intervention Type: BEHAVIORAL

such as walking, jogging, swimming, Tai Chi, etc. It needs to be at a certain frequency and intensity

Control group

only receive conventional MHD treatment, no requirement for exercise.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

exercise

such as walking, jogging, swimming, Tai Chi, etc. It needs to be at a certain frequency and intensity

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yunfeng Xia

OTHER

Sponsor Role: lead

Responsible Party

Yunfeng Xia

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yunfeng Xia, Dr.

Role: primary

xyf0920@126.com

86-23-89012256

Other Identifiers

First ChongQing MU

Identifier Type: -

Identifier Source: org_study_id