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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01728415
Other study ID # 2012/1459
Secondary ID 126/12-303.0
Status Recruiting
Phase N/A
First received November 13, 2012
Last updated September 19, 2014
Start date October 2012
Est. completion date September 2016

Study information

Verified date September 2014
Source Oslo University Hospital
Contact Birgitta Blakstad Nilsson, PhD
Phone +4793210913
Email b.b.nilsson@medisin.uio.no
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of high intensity interval training compared to moderate exercise training and a control group on exercise capacity and quality of life in patients with end stage renal disease on hemodialysis.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date September 2016
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients on hemodialysis = 3 months

Exclusion Criteria:

- Acute infection

- Systolic BP>180 mmHG or diabolic BP>105 mmHG

- Unstable angina pectoris

- Serious rhythm disturbances

- Hyperkalemic (> 6 mmol/L),

- Unstable diabetes mellitus

- Wheelchair

- Dialyses access on lower extremities

- Haemoglobin < 9 g/dl

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Other:
exercise
Group A: high intensity exercise training Group B: moderate intensity exercise training C: Control group

Locations

Country Name City State
Norway Oslo University Hospital Oslo Postboks 4950 Nydalen

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital Norwegian Fund for Postgraduate Training in Physiotherapy

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak oxygen uptake Canges from baseline in peak oxygen uptake at 16 weeks baseline, 16 weeks No
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