Effects of Exercise and Exercise Counselling in Hemodialysis Patients.

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

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Diseases; Chronic Kidney Diseases; Physical Activity; End Stage Renal Disease; Kidney Failure
• Intervention / Treatment: Other: Functional training and cycling; Other: Cycling

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jernej Pajek, MD, PhD; Phone Number: +38615225360; Email: jernej.pajek@kclj.si
• Study Contact Backup: Name: Špela Bogataj; Phone Number: +38640415766; Email: sspelabogataj@gmail.com

Study Locations

• Slovenia
  • Ljubljana, Slovenia
    • Recruiting
    • University Medical Centre
    • Contact: Jernej Pajek, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional training and cycling; Participants in this group will perform 20 minutes of functional training before dialysis (in the first 8 weeks) and intradialysis cycling exercise during dialysis. Participants will also receive exercise counselling; investigators will teach them how to practice at home by practice and examples given during the 20 minutes of functional training pre-dialysis. In the second phase of additional eight weeks participants will perform the functional training at home on non-dialysis days in addition to intradialysis cycling. Kinesiologist will monitor, advice and motivate them.	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.; Other Names: Experimental group; Functional training, intradialysis cycling and counselling
Active Comparator: Cycling; This active control comparator group will perform intradialytic cycling on an adapted ergometer 3 times per week for 4 months without functional training prior to dialysis procedure and without exercise counselling.	Other: 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.; Other Names: Active control group; Intradialysis cycling exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6-minute walk test distance	Distance made in 6-minute walk test (submaximal aerobic endurance)	baseline, 8 weeks and 16 weeks
Change in lean and fat body mass	Body composition measurements by bioimpedance	baseline, 8 weeks and 16 weeks
Change in serum interleukin-6 (IL-6)	Predialysis serum concentration of IL-6 as a measure of inflammation	baseline, 8 weeks and 16 weeks
Change in Stork balance test time	Stork balance test time as a measure of balance	baseline, 8 weeks, 16 weeks
Change in sit-and-reach test distance	Sit-and-reach test distance as a measure of flexibility	baseline, 8 weeks, 16 weeks

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Collaborators: Slovenian Research Agency
• Investigators: Study Chair: Jadranka Buturović Ponikvar, MD, PhD, UMC Ljubljana

Publications and helpful links

General Publications

• Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
• Bogataj S, Pajek J, Buturovic Ponikvar J, Pajek M. Functional training added to intradialytic cycling lowers low-density lipoprotein cholesterol and improves dialysis adequacy: a randomized controlled trial. BMC Nephrol. 2020 Aug 18;21(1):352. doi: 10.1186/s12882-020-02021-2.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2017
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: physical activity; exercise; rehabilitation; strength training; chronic kidney disease; aerobic exercise; end-stage renal disease; hemodialysis; resistance training; kidney failure; chronic renal failure; dialysis patients; intradialytic exercise; functional training
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: DIAGIBII

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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