NCT01728415

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 22, 2014

Status Verified

September 1, 2014

Enrollment Period

2.2 years

First QC Date

November 13, 2012

Last Update Submit

September 19, 2014

Conditions

Keywords

ExerciseHemodialysisPhysical therapyhigh-intensity

Outcome Measures

Primary Outcomes (1)

  • Peak oxygen uptake

    Canges from baseline in peak oxygen uptake at 16 weeks

    baseline, 16 weeks

Study Arms (3)

A: Exercise

EXPERIMENTAL

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

Other: exercise

B: Execise

ACTIVE COMPARATOR

Moderate continuous exercise training

Other: exercise

C: Controll

NO INTERVENTION

Usual care without exercise training

Interventions

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

A: ExerciseB: Execise

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients on hemodialysis ≥ 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Postboks 4950 Nydalen, 0424, Norway

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Renal Insufficiency, ChronicMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Birgitta Blakstad Nilsson, PhD

CONTACT

Aud Eldrid Stenehjem, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Oslo ExDia-study

Study Record Dates

First Submitted

November 13, 2012

First Posted

November 19, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2014

Study Completion

September 1, 2016

Last Updated

September 22, 2014

Record last verified: 2014-09

Locations