The Effect of Active Exercise on Maintenance Haemodialysis Patients

NCT06568835 | Recruiting

• 1 other identifier: First ChongQing MU
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Dialysis

Keywords

Exercise; Inflammation; Nutrition; Muscular Atrophy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• prealbumin

  Baseline and half year, 1 year

• albumin

  Baseline and half year, 1 year

• haemoglobin

  Baseline and half year, 1 year

• blood lipids

  Baseline and half year, 1 year

• c-reactive protein

  Baseline and half year, 1 year

Study Arms (2)

exercise group

EXPERIMENTAL

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

Control group

NO INTERVENTION

only receive conventional MHD treatment, no requirement for exercise.

Interventions

exercise BEHAVIORAL

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

exercise group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yunfeng Xia: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

MeSH Terms

Conditions

Motor Activity; Inflammation; Muscular Atrophy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Model Details: Active 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). Control group: only receive conventional MHD treatment, no requirement for exercise.

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 23, 2024
• Study Start: January 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)