Heart Failure, CongestiveNCT00156234
Skeletal Muscle Dysfunction in Heart Failure
A study testing One-knee extension ergometer in people with Heart Failure, Congestive, run by Ullevaal University Hospital at 2 sites in Norway.
Trial summary
Patients suffering from congestive heart failure report reduced exercise capacity. This skeletal muscle dysfunction is also detectable when using small muscle groups which should not put any demand on the heart. Read more about this study
- Who is it for?
- Ages 40 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- One-knee extension ergometer
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 2 sitesNorway
- Study dates
- Mar 2005to not given
- 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 40 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Coronary Heart Failure
- Ejection fraction <35%
- NYHA 2-3
- Spirometry FEV1 > 80%
Who cannot join
- Cardiomyopathy
- Transplantation candidate
- Active malignancy
- Restraining skeletal-muscular disease
- Claudication in legs
- Hospitalized last 30 days due to acute ischemic episode
Show all 11Show fewer
- Intravenous inotrope or vasodilatating drugs last 14 days prior to inclusion
- AMI last 8 weeks prior to inclusion
- Organized training last 4 months
- Smoking on daily basis last 4 months
- Creatinin < 150microliters/liter
Trial locations and contacts
2 sites in 1 country.
Norway2 sites, 2 recruiting
- Recruiting
Institute for Experimental Medical Research
Oslo, Oslo, 0407
Ole M Sejersted, Professor, 23 01 68 00 ext. 47, o.m.sejersted@medisin.uio.no
Per Kristian B Lunde, Post Doc, 23 01 68 35 ext. 47, p.k.lunde@medisin.uio.no
- Recruiting
Norwegian School of Sport Sciences
Oslo, Oslo, 0806
Jostein Hallén, Professor, 23 26 23 14 ext. 47, jostein.hallen@nih.no
Gunnar Petersen, Ph.D student, gunnar.petersen@nih.no
About this study
Official title: Training and Congestive Heart Failure
Patients suffering from congestive heart failure report reduced exercise capacity. This skeletal muscle dysfunction is also detectable when using small muscle groups which should not put any demand on the heart.
We hypothesize that congestive heart failure has systemic effects that causes the skeletal muscle dysfunction.
- Conditions
- Heart Failure, Congestive
- Being tested
- One-knee extension ergometer
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-knee extension ergometerBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2005
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 Heart Failure, CongestiveStudies of the same condition, open and under way.
- 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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Health Association, Norwegian School of Sport Sciences, The Research Council of Norway, University of Oslo
- Investigators
- Ole M Sejersted, Professor, Study chair, Institute for Experimental Medical Research, Ullevaal University HospitalPer Kristian B Lunde, Post Doc, Study director, Institute for Experimental Medical Research, Ullevaal University HospitalIvar Sjaastad, Post Doc, Study director, Institute for Experimental Medical Research, Ullevaal University HospitalJostein Hallen, Professor, Study chair, Norwegian School of Sport SciencesMorten Munkvik, Ph.D student, Principal investigator, Institute for Experimental Medical Research, Ullevaal University HospitalTommy A Rehn, Vit.ass., Principal investigator, Institute for Experimental Medical Research, Ullevaal University HospitalGunnar S Petersen, Ph.D student, Principal investigator, Norwegian School of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156234
- Sponsor's protocol ID
- TRUST-001
- Other IDs
- Helse Øst, Helse og rehabilitering
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Publications
Munkvik M, Rehn TA, Slettalokken G, Hasic A, Hallen J, Sjaastad I, Sejersted OM, Lunde PK. Training effects on skeletal muscle calcium handling in human chronic heart failure. Med Sci Sports Exerc. 2010 May;42(5):847-55. doi: 10.1249/MSS.0b013e3181c29ec1.
PubMed 19996998
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training and Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00156234
- Acronym / sponsor ID
- TRUST-001
- Conditions
- Heart Failure, Congestive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Health Association, Norwegian School of Sport Sciences, The Research Council of Norway, University of Oslo
- Study start
- Mar 2005
- First posted
- 12 Sep 2005 (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.
Patients suffering from congestive heart failure report reduced exercise capacity. This skeletal muscle dysfunction is also detectable when using small muscle groups which should not put any demand on the heart.
We hypothesize that congestive heart failure has systemic effects that causes the skeletal muscle dysfunction.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 40 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Coronary Heart Failure
- Ejection fraction <35%
- NYHA 2-3
- Spirometry FEV1 > 80%
Key exclusion criteria (11 listed)
- Cardiomyopathy
- Transplantation candidate
- Active malignancy
- Restraining skeletal-muscular disease
- Claudication in legs
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 |
|---|---|---|
| One-knee extension ergometer | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
- Derived from this study: PubMed 19996998Munkvik M, Rehn TA, Slettalokken G, Hasic A, Hallen J, Sjaastad I, Sejersted OM, Lunde PK. Training effects on skeletal muscle calcium handling in human chronic heart failure. Med Sci Sports Exerc. 2010 May;42(5):847-55. doi: 10.1249/MSS.0b013e3181c29ec1.
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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.
Institute for Experimental Medical Research
Oslo, Norway
Ole M Sejersted, Professor study chair
Institute for Experimental Medical Research, Ullevaal University Hospital
Per Kristian B Lunde, Post Doc study director
Institute for Experimental Medical Research, Ullevaal University Hospital
Ivar Sjaastad, Post Doc study director
Institute for Experimental Medical Research, Ullevaal University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-knee extension ergometer in people with Heart Failure, Congestive, run by Ullevaal University Hospital at 2 sites 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 4 inclusion and 11 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 12 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00156234, 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 12 Sep 2005; AzTrials last refreshed its copy on 27 Oct 2026.