Effects of Exercise and Exercise Counselling in Hemodialysis Patients.

NCT ID: NCT03334123

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-08
• Study Completion Date: 2019-06-30

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Functional training and cycling

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Cycling

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Functional training, intradialysis cycling and counselling; Experimental group; Intradialysis cycling exercise; Active control group

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Slovenian Research Agency

OTHER

Sponsor Role: collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Jernej Pajek

Jernej Pajek, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jadranka Buturović Ponikvar, MD, PhD

Role: STUDY_CHAIR

UMC Ljubljana

Locations

University Medical Centre

Ljubljana, , Slovenia

Site Status: RECRUITING

Countries

Slovenia

Central Contacts

Jernej Pajek, MD, PhD

Role: CONTACT

jernej.pajek@kclj.si

+38615225360

Špela Bogataj

Role: CONTACT

sspelabogataj@gmail.com

+38640415766

Facility Contacts

Jernej Pajek, PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 35018639 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32811448 (View on PubMed)

Other Identifiers

DIAGIBII

Identifier Type: -

Identifier Source: org_study_id