Effects of Exercise and Exercise Counselling in Hemodialysis Patients.

Physical Activity Clinical Trial

Official title:

Effects of Exercise and Exercise Counselling in Hemodialysis Patients: a Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03334123
• Other study ID #: DIAGIBII
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: June 2019

Study information

• Verified date: May 2018
• Source: University Medical Centre Ljubljana
• Contact: Jernej Pajek, MD, PhD
• Phone: +38615225360
• Email: jernej.pajek[@]kclj.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to determine the effect of functional exercise and training counseling by kinesiotherapist in addition to the basic exercise program of cycling during dialysis on physical performance of dialysis patients.

Description:

Study will include 86 dialysis patients. Investigators will first test the strength of lower limbs with sit-to-stand test, handgrip strength, flexibility, balance, submaximal aerobic capacity, physical characteristics and clinical parameters. After that randomization of patients in two groups will be made - one experimental and one active control group. Patients who will refuse to exercise will be invited to a non-randomized inactive control group (without exercise).

The experimental group will attend 3 times weekly a guided functional exercise before the dialysis procedure for 20 minutes and perform a cycling session during dialysis in the first phase of the study, which will last for 8 weeks. During this time experimental group will receive exercise counselling; instructions how to practice at home will be given by examples and training during functional exercise predialysis sessions.

In the second phase of the study for additional eight weeks participants will be instructed to exercise at home using the skills mastered during the first study phase on non-dialysis days, and continue with the program of intradialysis cycling. Investigators will give them advice, monitor and motivate them.

The active control group will perform intradialytic exercise (intradialysis cycling equal to cycling program of experimental group) during dialysis procedure for four months.

The primary end-point of the study is a change in the 10-repetition sit-to-stand test time as a measure of strength of lower extremities.

Exercise program will be run by a kinesiologist. Main hypothesis is that the guided functional exercise under the surveillance of a kinesiologist added to intradialysis cycling program statistically significantly improves patient's physical performance as compared to the program of intradialysis cycling alone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: June 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• dialysis patients on renal replacement therapy with chronic hemodialysis,

• duration of hemodialysis treatment for at least 3 months,

• age 18-90 years,

• capable of independent walking and independent feeding.

Exclusion Criteria:

• the presence of chronic malignant or infectious disease,

• uncontrolled arterial hypertension with an average of the last five pre-dialysis blood pressure values above 180/100 mm Hg,

• unstable angina pectoris or Canadian Cardiovascular Society class 2-4,

• heart failure New York Heart Association class 3 and 4,

• the presence of a psychotic illness or a mental disability,

• a condition with an amputated limb (more than 2 fingers on the lower limb and / or more than 2 fingers on the upper limb)

• any other condition that causes the clinical unstability of the patient (i.e. repetitive gastrointestinal hemmorrhagies, liver cirrhosis with frequent exacerbations, advanced dementia with poor cooperation of the patient)

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure
• Kidney Failure, Chronic
• Physical Activity
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• Functional training and cycling
First 8 weeks: patients will perform 20 minutes of functional training before their dialysis procedure. The exercise program will be run by kinesiologists, who will also teach patients how to perform exercises on their own at home. During intradialysis cycling 3 times weekly participants will cycle on adapted ergometer. Participants will start with 10 - 15 minutes of cycling and then gradually increase time and intensity up to 45 minutes of duration. Second phase of 8 weeks: participants will no longer perform functional training before dialysis but will be motivated, monitored and advised to perform functional exercise at home on non-dialysis days for 20-30 minutes and continue with cycling sessions during the dialysis procedures three times weekly.
• Cycling
First 8 weeks: cycling on an adapted ergometer during dialysis; starting with 10 - 15 minutes of cycling and then gradually increasing time and intensity up to 45 minutes of duration. Second 8 weeks: continue with cycling at the target duration and intensity during dialysis.

Locations

Country	Name	City	State
Slovenia	University Medical Centre	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	Slovenian Research Agency

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 10 repetition sit-to-stand test time	Performance of the sit-to-stand test involves activation of the lower limb muscles; the test measures lower limb strength. Participants are required to 10 times stand up from and sit down on an armless chair as quickly as possible. Their arms should be folded across their chest.	baseline, 8 weeks and 16 weeks
Secondary	Change in 6-minute walk test distance	Distance made in 6-minute walk test (submaximal aerobic endurance)	baseline, 8 weeks and 16 weeks
Secondary	Change in lean and fat body mass	Body composition measurements by bioimpedance	baseline, 8 weeks and 16 weeks
Secondary	Change in serum interleukin-6 (IL-6)	Predialysis serum concentration of IL-6 as a measure of inflammation	baseline, 8 weeks and 16 weeks
Secondary	Change in Stork balance test time	Stork balance test time as a measure of balance	baseline, 8 weeks, 16 weeks
Secondary	Change in sit-and-reach test distance	Sit-and-reach test distance as a measure of flexibility	baseline, 8 weeks, 16 weeks