Chronic Renal DiseaseOsloExDiaNCT01728415
Effects of High-intensity Interval Training in Patients in Hemodialysis
A study testing exercise in people with Chronic Renal Disease, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Renal Disease
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2012to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on hemodialysis ≥ 3 months
Who cannot join
- Acute infection
- Systolic BP>180 mmHG or diabolic BP>105 mmHG
- Unstable angina pectoris
- Serious rhythm disturbances
- Hyperkalemic (> 6 mmol/L),
- Unstable diabetes mellitus
Show all 9Show fewer
- Wheelchair
- Dialyses access on lower extremities
- Haemoglobin < 9 g/dl
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, Postboks 4950 Nydalen, 0424
Birgitta Blakstad Nilsson, PhD, +47 93210913
Heidi B Næss
About this study
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.
- Conditions
- Chronic Renal Disease
- Being tested
- exercise
- Keywords
- Exercise, Hemodialysis, Physical therapy, high-intensity
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Group A: high intensity exercise training Group B: moderate intensity exercise training C: Control group
| Study group | Role | What they receive |
|---|---|---|
| A: Exercise | Experimental | High intensity interval exercise training (3 x 3 minutes of intensity abow 85% og Heart rate peak) Receives: Other: exercise |
| B: Execise | Active comparator | Moderate continuous exercise training Receives: Other: exercise |
| C: Controll | No intervention | Usual care without exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake
Canges from baseline in peak oxygen uptake at 16 weeks
Measured: baseline, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2014 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Responsible party
- Principal investigator, Birgitta Blakstad Nilsson, PhD, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728415
- Sponsor's protocol ID
- 2012/1459
- Other IDs
- 126/12-303.0
- Acronym
- OsloExDia
- Status last verified
- Sep 2014
- First submitted
- 13 Nov 2012
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31798950
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-intensity Interval Training in Patients in Hemodialysis
- ClinicalTrials.gov ID
- NCT01728415
- Acronym / sponsor ID
- OsloExDia / 2012/1459
- Conditions
- Chronic Renal Disease
- Keywords
- Exercise, Hemodialysis, Physical therapy, high-intensity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 19 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: Exercise | Experimental | Other: exerciseHigh intensity interval exercise training (3 x 3 minutes of intensity abow 85% og Heart rate peak) |
| B: Execise | Active comparator | Other: exerciseModerate continuous exercise training |
| C: Controll | No intervention | –Usual care without exercise training |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients on hemodialysis ≥ 3 months
Key exclusion criteria (9 listed)
- Acute infection
- Systolic BP>180 mmHG or diabolic BP>105 mmHG
- Unstable angina pectoris
- Serious rhythm disturbances
- Hyperkalemic (> 6 mmol/L),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseGroup A: high intensity exercise training Group B: moderate intensity exercise training C: Control group | Other | A: Exercise, B: Execise |
Primary outcome
Peak oxygen uptake
Time frame: baseline, 16 weeks
Canges from baseline in peak oxygen uptake at 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
- Derived from this study: PubMed 31798950Nilsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Chronic Renal Disease, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgitta Blakstad Nilsson, PhD (+4793210913, b.b.nilsson@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (time frame: baseline, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01728415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2014.