Effects of Exercise and Exercise Counselling in Hemodialysis Patients.

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Unknown status

CT.gov ID

NCT03334123

Collaborator

Slovenian Research Agency (Other)

Enrollment

Location

Arms

18.7

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Activity Kidney Diseases Kidney Failure Chronic Kidney Diseases End Stage Renal Disease	Other: Functional training and cycling Other: Cycling	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 8, 2017

Anticipated Primary Completion Date :

Apr 1, 2019

Anticipated Study Completion Date :

Jun 1, 2019

Arms and Interventions

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

Functional training, intradialysis cycling and counselling

Experimental group

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:

Intradialysis cycling exercise

Active control group

Outcome Measures

Primary Outcome Measures

Change in 10 repetition sit-to-stand test time [baseline, 8 weeks and 16 weeks]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)