Effects of Intradialytic Aerobic Exercise in Chronic Kidney Patients

NCT06055283 | Not Yet Recruiting

• 1 other identifier: ECRC/CKD
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate the effects of intradialytic aerobic exercise on muscle capacity, functionality and motivation of patients with chronic kidney disease undergoing hemodialysis. The main question it aims to answer are: • Is intradialytic aerobic exercise at moderate intensity effective in improving peripheral muscle function, functional status and motivation in patients with chronic kidney disease?

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• six minute step test

  A step 20 centimeters high will be used and the patient will be instructed to go up and down it as many times during the 6 minutes, according to free cadence and will be instructed not to use the upper limbs

  12 weeks

Secondary Outcomes (9)

• muscle strength

  12 weeks

• Daily life physical activity

  12 weeks

• Behavior Regulation Questionnaire for Physical Exercise

  12 weeks

• index of self-determination and basic psychological needs

  12 weeks

• Pittsburg Sleep Quality Index

  12 weeks

Study Arms (2)

Training group

EXPERIMENTAL

Aerobic exercise training on moderate intensity.

Other: Aerobic exercise

Control group

NO INTERVENTION

Monitoring.

Interventions

Aerobic exercise OTHER

The training group will receive aerobic exercise and the intensities will be controlled considering the percentage of estimated maximum heart rate. The training will be performed with a cycle ergometer with a total of 40 minutes of intradialytic aerobic exercise in the training group. To reduce the effects of intolerance to aerobic exercise, a week of adaptation will be performed, with a frequency of three sessions, in the first two hours of hemodialysis, lasting 40 minutes at maximum heart rate intensity of up to 74% and BORG up to 4 (low intensity). Afterwards, the patients will perform the prediction training for 12 weeks, at the frequency of three training sessions per week in the first two hours of hemodialysis. Each training session will start with a 5-minute warm-up at low intensity, 30 minutes of main training with maximum heart rate intensity 55% to 74% and BORG 5 to 7 (moderate intensity) and will end with a 5-minute cool-down at low intensity.

Training group

Eligibility Criteria

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

You may qualify if:

• diagnosis of chronic kidney disease undergoing renal replacement therapy via hemodialysis
• aged 20 to 65 years
• low body mass index at overweight (21 kg/m2 to 29.9 kg/m2)
• regular renal replacement therapy via hemodialysis for 6 months, without acute complications related to the diagnosis and/or comorbidities for the period of 3 months prior to the evaluation and intervention.

You may not qualify if:

• patients who do not reach a score equal to or above 20 assessed by the Mini Mental State Examination
• severe heart failure according to the New York Heart Association classification
• musculoskeletal alteration that prevents the correct execution of the assessment activities
• who have participated in other exercise protocols in the last 6 months prior to the present study
• patients who show signs of clinical instability during the hemodialysis procedure or after training for two consecutive sessions will be excluded throughout the protocol.

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Jéssica Canizelli Gonçalez, Ms

CONTACT

47996087774; jessicacgoncalez@hotmail.com

Elaine Paulin, PhD

CONTACT

(48) 3664-8600; elaine.paulin@udesc.br

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: PRINCIPAL INVESTIGATOR
• PI Title: doctoral student

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: September 26, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share