Effects of Exercise and Exercise Counselling in Hemodialysis Patients.

NCT03334123 | Unknown

• 1 other identifier: DIAGIBII
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Activity; Kidney Diseases; Kidney Failure; Chronic Kidney Diseases; End Stage Renal Disease

Keywords

exercise; aerobic exercise; functional training; strength training; resistance training; kidney failure; rehabilitation; physical activity; hemodialysis; dialysis patients; chronic renal failure; chronic kidney disease; end-stage renal disease; intradialytic exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in 6-minute walk test distance

  baseline, 8 weeks and 16 weeks

• Change in lean and fat body mass

  baseline, 8 weeks and 16 weeks

• Change in serum interleukin-6 (IL-6)

  baseline, 8 weeks and 16 weeks

• Change in Stork balance test time

  baseline, 8 weeks, 16 weeks

• Change in sit-and-reach test distance

  baseline, 8 weeks, 16 weeks

Study Arms (2)

Functional training and cycling

EXPERIMENTAL

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

Cycling

ACTIVE COMPARATOR

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

Interventions

Functional training and cycling OTHER

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.

Also known as: Functional training, intradialysis cycling and counselling, Experimental group

Functional training and cycling

Cycling OTHER

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.

Also known as: Intradialysis cycling exercise, Active control group

Cycling

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Slovenian Research Agency: collaborator

Study Sites (1)

University Medical Centre

Ljubljana, Slovenia

RECRUITING

Related Publications (2)

• 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.

  PMID: 35018639 DERIVED

• 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.

  PMID: 32811448 DERIVED

MeSH Terms

Conditions

Motor Activity; Kidney Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

Counseling

Condition Hierarchy (Ancestors)

Behavior; 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)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jadranka Buturović Ponikvar, MD, PhD

  UMC Ljubljana

  STUDY CHAIR

Central Study Contacts

Jernej Pajek, MD, PhD

CONTACT

+38615225360; jernej.pajek@kclj.si

Špela Bogataj

CONTACT

+38640415766; sspelabogataj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jernej Pajek, MD, PhD

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: November 7, 2017
• Study Start: November 8, 2017
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

SL (1)