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Effects of Exercise and Exercise Counselling in Hemodialysis Patients.

Primary Purpose

Physical Activity, Kidney Diseases, Kidney Failure

Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Functional training and cycling
Cycling
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Physical Activity focused on measuring 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

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Functional training and cycling

Cycling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2017
Last Updated
May 10, 2018
Sponsor
University Medical Centre Ljubljana
Collaborators
Slovenian Research Agency
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1. Study Identification

Unique Protocol Identification Number
NCT03334123
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
Collaborators
Slovenian Research Agency

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Functional training and cycling
Arm Type
Experimental
Arm Description
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.
Arm Title
Cycling
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Functional training and cycling
Other Intervention Name(s)
Functional training, intradialysis cycling and counselling, Experimental group
Intervention Description
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
Intervention Name(s)
Cycling
Other Intervention Name(s)
Intradialysis cycling exercise, Active control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 10 repetition sit-to-stand test time
Description
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.
Time Frame
baseline, 8 weeks and 16 weeks
Secondary Outcome Measure Information:
Title
Change in 6-minute walk test distance
Description
Distance made in 6-minute walk test (submaximal aerobic endurance)
Time Frame
baseline, 8 weeks and 16 weeks
Title
Change in lean and fat body mass
Description
Body composition measurements by bioimpedance
Time Frame
baseline, 8 weeks and 16 weeks
Title
Change in serum interleukin-6 (IL-6)
Description
Predialysis serum concentration of IL-6 as a measure of inflammation
Time Frame
baseline, 8 weeks and 16 weeks
Title
Change in Stork balance test time
Description
Stork balance test time as a measure of balance
Time Frame
baseline, 8 weeks, 16 weeks
Title
Change in sit-and-reach test distance
Description
Sit-and-reach test distance as a measure of flexibility
Time Frame
baseline, 8 weeks, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jernej Pajek, MD, PhD
Phone
+38615225360
Email
jernej.pajek@kclj.si
First Name & Middle Initial & Last Name or Official Title & Degree
Špela Bogataj
Phone
+38640415766
Email
sspelabogataj@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jadranka Buturović Ponikvar, MD, PhD
Organizational Affiliation
UMC Ljubljana
Official's Role
Study Chair
Facility Information:
Facility Name
University Medical Centre
City
Ljubljana
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jernej Pajek, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35018639
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.
Results Reference
derived
PubMed Identifier
32811448
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.
Results Reference
derived

Learn more about this trial

Effects of Exercise and Exercise Counselling in Hemodialysis Patients.

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