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| Name | Class |
|---|---|
| Slovenian Research Agency | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-minute walk test distance | Distance made in 6-minute walk test (submaximal aerobic endurance) | baseline, 8 weeks and 16 weeks |
| Change in lean and fat body mass | Body composition measurements by bioimpedance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jernej Pajek, MD, PhD | Contact | +38615225360 | jernej.pajek@kclj.si | |
| Å pela Bogataj | Contact | +38640415766 | sspelabogataj@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jadranka Buturović Ponikvar, MD, PhD | UMC Ljubljana | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre | Recruiting | Ljubljana | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35018639 | Derived | 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. | |
| 32811448 | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 25, 2020 | |
| Reset | Apr 7, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 25, 2020 | Apr 7, 2020 |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D007674 | Kidney Diseases |
| D051437 | Renal Insufficiency |
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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|
|
| 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. |
|
|
| baseline, 8 weeks and 16 weeks |
| Change in serum interleukin-6 (IL-6) | Predialysis serum concentration of IL-6 as a measure of inflammation | baseline, 8 weeks and 16 weeks |
| Change in Stork balance test time | Stork balance test time as a measure of balance | baseline, 8 weeks, 16 weeks |
| Change in sit-and-reach test distance | Sit-and-reach test distance as a measure of flexibility | baseline, 8 weeks, 16 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005159 | Health Care Facilities Workforce and Services |