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

Primary Purpose

Chronic Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
exercise
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Disease focused on measuring Exercise, Hemodialysis, Physical therapy, high-intensity

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

A: Exercise

B: Execise

C: Controll

Arm Description

High intensity interval exercise training (3 x 3 minutes of intensity abow 85% og Heart rate peak)

Moderate continuous exercise training

Usual care without exercise training

Outcomes

Primary Outcome Measures

Peak oxygen uptake
Canges from baseline in peak oxygen uptake at 16 weeks

Secondary Outcome Measures

Full Information

First Posted
November 13, 2012
Last Updated
September 19, 2014
Sponsor
Oslo University Hospital
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy
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1. Study Identification

Unique Protocol Identification Number
NCT01728415
Brief Title
Effects of High-intensity Interval Training in Patients in Hemodialysis
Acronym
OsloExDia
Official Title
Effects of High-intensity Interval Training in Patients in Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Disease
Keywords
Exercise, Hemodialysis, Physical therapy, high-intensity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: Exercise
Arm Type
Experimental
Arm Description
High intensity interval exercise training (3 x 3 minutes of intensity abow 85% og Heart rate peak)
Arm Title
B: Execise
Arm Type
Active Comparator
Arm Description
Moderate continuous exercise training
Arm Title
C: Controll
Arm Type
No Intervention
Arm Description
Usual care without exercise training
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
Group A: high intensity exercise training Group B: moderate intensity exercise training C: Control group
Primary Outcome Measure Information:
Title
Peak oxygen uptake
Description
Canges from baseline in peak oxygen uptake at 16 weeks
Time Frame
baseline, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birgitta Blakstad Nilsson, PhD
Phone
+4793210913
Email
b.b.nilsson@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Aud Eldrid Stenehjem, PhD
Phone
+4790667069
Email
uxaust@ous-hf.no
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
State/Province
Postboks 4950 Nydalen
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgitta Blakstad Nilsson, PhD
Phone
+47 93210913
First Name & Middle Initial & Last Name & Degree
Heidi B Næss

12. IPD Sharing Statement

Citations:
PubMed Identifier
31798950
Citation
Nilsson BB, Bunaes-Naess H, Edvardsen E, Stenehjem AE. High-intensity interval training in haemodialysis patients: a pilot randomised controlled trial. BMJ Open Sport Exerc Med. 2019 Nov 10;5(1):e000617. doi: 10.1136/bmjsem-2019-000617. eCollection 2019.
Results Reference
derived

Learn more about this trial

Effects of High-intensity Interval Training in Patients in Hemodialysis

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