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Effects of High-intensity Interval Training in Patients in Hemodialysis (OsloExDia)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Oslo University Hospital
Sponsor:
Collaborator:
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by (Responsible Party):
Birgitta Blakstad Nilsson, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01728415
First received: November 13, 2012
Last updated: September 19, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Chronic Renal Disease
Other: exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of High-intensity Interval Training in Patients in Hemodialysis

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Peak oxygen uptake [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
    Canges from baseline in peak oxygen uptake at 16 weeks


Estimated Enrollment: 18
Study Start Date: October 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Exercise
High intensity interval exercise training (3 x 3 minutes of intensity abow 85% og Heart rate peak)
Other: exercise
Group A: high intensity exercise training Group B: moderate intensity exercise training C: Control group
Active Comparator: B: Execise
Moderate continuous exercise training
Other: exercise
Group A: high intensity exercise training Group B: moderate intensity exercise training C: Control group
No Intervention: C: Controll
Usual care without exercise training

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728415

Contacts
Contact: Birgitta Blakstad Nilsson, PhD +4793210913 b.b.nilsson@medisin.uio.no
Contact: Aud Eldrid Stenehjem, PhD +4790667069 uxaust@ous-hf.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Postboks 4950 Nydalen, Norway, 0424
Contact: Birgitta Blakstad Nilsson, PhD    +47 93210913      
Principal Investigator: Heidi B Næss         
Sponsors and Collaborators
Oslo University Hospital
Norwegian Fund for Postgraduate Training in Physiotherapy
  More Information

No publications provided

Responsible Party: Birgitta Blakstad Nilsson, PhD, The Oslo ExDia-study, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01728415     History of Changes
Other Study ID Numbers: 2012/1459, 126/12-303.0
Study First Received: November 13, 2012
Last Updated: September 19, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Exercise
Hemodialysis
Physical therapy
high-intensity

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014