Clinical trial NCT03334123: Effects of Exercise and Exercise Counselling in Hemodialysis Patients.
Official title: Effects of Exercise and Exercise Counselling in Hemodialysis Patients: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Slovenian Research Agency
First posted: 2017-11-07
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Change in 10 repetition sit-to-stand test time
timeFrame: baseline, 8 weeks and 16 weeks
Secondary outcomes:
measure: Change in 6-minute walk test distance
timeFrame: baseline, 8 weeks and 16 weeks
measure: Change in lean and fat body mass
timeFrame: baseline, 8 weeks and 16 weeks
measure: Change in serum interleukin-6 (IL-6)
timeFrame: baseline, 8 weeks and 16 weeks
measure: Change in Stork balance test time
timeFrame: baseline, 8 weeks, 16 weeks
measure: Change in sit-and-reach test distance
timeFrame: baseline, 8 weeks, 16 weeks
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre
Study officials:
affiliation: UMC Ljubljana
name: Jadranka Buturović Ponikvar, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.