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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03334123 |
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Date of registration:
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10/10/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Exercise and Exercise Counselling in Hemodialysis Patients.
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Scientific title:
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Effects of Exercise and Exercise Counselling in Hemodialysis Patients: a Randomized Controlled Trial. |
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Date of first enrolment:
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November 8, 2017 |
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Target sample size:
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86 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03334123 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Jernej Pajek, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Jernej Pajek, MD, PhD |
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Address:
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Telephone:
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+38615225360 |
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Email:
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jernej.pajek@kclj.si |
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Affiliation:
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Name:
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Jadranka Buturovic Ponikvar, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UMC Ljubljana |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Kidney Diseases
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End Stage Renal Disease
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Kidney Diseases
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Physical Activity
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Kidney Failure
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Intervention(s)
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Other: Cycling
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Other: Functional training and cycling
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Primary Outcome(s)
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Change in 10 repetition sit-to-stand test time
[Time Frame: baseline, 8 weeks and 16 weeks]
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Secondary Outcome(s)
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Change in sit-and-reach test distance
[Time Frame: baseline, 8 weeks, 16 weeks]
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Change in lean and fat body mass
[Time Frame: baseline, 8 weeks and 16 weeks]
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Change in Stork balance test time
[Time Frame: baseline, 8 weeks, 16 weeks]
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Change in 6-minute walk test distance
[Time Frame: baseline, 8 weeks and 16 weeks]
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Change in serum interleukin-6 (IL-6)
[Time Frame: baseline, 8 weeks and 16 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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