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

September 19, 2014 updated by: Birgitta Blakstad Nilsson, PhD, Oslo University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Postboks 4950 Nydalen
      • Oslo, Postboks 4950 Nydalen, Norway, 0424
        • Recruiting
        • Oslo University Hospital
        • Contact:
          • Birgitta Blakstad Nilsson, PhD
          • Phone Number: +47 93210913
        • Principal Investigator:
          • Heidi B Næss

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak oxygen uptake
Time Frame: baseline, 16 weeks
Canges from baseline in peak oxygen uptake at 16 weeks
baseline, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Norwegian Fund for Postgraduate Training in Physiotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

November 13, 2012

First Posted (Estimate)

November 19, 2012

Study Record Updates

Last Update Posted (Estimate)

September 22, 2014

Last Update Submitted That Met QC Criteria

September 19, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/1459
  • 126/12-303.0 (Other Grant/Funding Number: The Norwegian Fund for Post-Graduate Training in Physiotherapy)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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