Congestive Heart FailureH2OBisNCT00676390
Estimated Physical Activity of Congestive Heart Failure Patients by a Physical Activity Questionnaire
A study testing doubly labelled water and questionnaire in people with Congestive Heart Failure, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The treatment and follow-up of congestive heart failure (CHF) represents a major part of France's health expenses. The beneficial effects of cardiac rehabilitation is well established, especially regarding the reduction of dyspnea, exercise limitation and fatigue and leads ultimately to a better quality of life. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- doubly labelled water and questionnaire
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to Jul 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Congestive Heart Failure
- Stade II, III of NYHA
- Between 20 to 80 years old
- EF < 45%
- Written informed consent
- French language
Who cannot join
- Corticotherapy
- Thyroid dysfunction
- Cachectic status
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Physiologie Clinique et de l'Exercice, CHU de Saint-Etienne
Saint-Etienne, 42000
About this study
Official title: Estimated Physical Activity of Congestive Heart Failure Patients by a Physical Activity Questionnaire : Concordance Study.
The treatment and follow-up of congestive heart failure (CHF) represents a major part of France's health expenses. The beneficial effects of cardiac rehabilitation is well established, especially regarding the reduction of dyspnea, exercise limitation and fatigue and leads ultimately to a better quality of life. Maintaining these benefits in secondary prevention requires an improvement in daily physical activity, which is challenging and supposes a close follow-up difficult to perform on a daily living basis. However, a better knowledge of the type and dose of daily physical activity of this population would be very beneficial for the practitioner to prescribe or advise individually the type and the dose of physical activity required to maintain the benefits of cardiac rehabilitation. To date, only a physical activity questionnaire adapted to CHF could provide information regarding both the type and dose of daily physical activity. Such a questionnaire has been developed by our research team and allows an estimation of daily energy expenditure as well as the daily energy expended in its physical activity dimensions (rest, activities < 3 MET, activities between 3 and 5 MET, and activities > 5 MET). During its first step of validation, daily and physical activity energy expenditure estimated by this questionnaire was correlated to various factors of physical condition and notably, to peak V'O2 (R=0.71), prognostic factor largely recognized in CHF. A second step of validation was a pilot study comparing the estimation of daily energy expenditure by the questionnaire with a measurement of free-living daily energy expenditure with the doubly labelled water (DLW) method in 11 middle-aged males patients suffering CHF (NYHA I to III). Daily energy expenditure estimated from the questionnaire was very close to daily energy expenditure measured from the DLW method (R2 = 0.81; individual relative error < 7%). However, the high cost of the DLW method reduced the population studied to a small sample, which is a major limitation of this study since the sample was somewhat different to general CHF population in France.
Read the detailed description
Therefore, the aim of the present study was to assess the validity of the questionnaire against the DLW method in a larger population of 30 patients with CHF more representative of the general population with CHF, including men and women, NYHA I to IV, with a larger age panel. Along with this concordance study, a measurement of the energy cost of specific physical activities of daily life is performed with an ambulatory gaz analyzer method to further validate the calculation method of daily energy expenditure from the questionnaire.
- Conditions
- Congestive Heart Failure
- Being tested
- doubly labelled water and questionnaire
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doubly labelled water and questionnaireOther
0.075 g.kg-1 and 2H2O et 0.15 g.kg-1 de H218O per oral at inclusion visit. physical activity questionnaire at inclusion visit
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Congestive Heart failure patients Receives: Other: doubly labelled water and questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate a physical activity questionnaire adapted to congestive heart failure patients by the questionnaire comparing with a measurement of free-living daily energy expenditure with the doubly labelled water.
Measured: D14 visit
Secondary outcomes (1)
To determinate the energy cost of specific physical activities of daily life performed with an ambulatory gaz analyzer method
Measured: D14 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2013
- Study completionJul 2013
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 Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Frederic ROCHE, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676390
- Sponsor's protocol ID
- 0708046
- Other IDs
- 2007- A00615-48, DGS 2007-0434
- Acronym
- H2OBis
- Status last verified
- Oct 2013
- First submitted
- 9 May 2008
- Last updated
- 28 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Garet M, Barthelemy JC, Degache F, Costes F, Da-Costa A, Isaaz K, Lacour JR, Roche F. A questionnaire-based assessment of daily physical activity in heart failure. Eur J Heart Fail. 2004 Aug;6(5):577-84. doi: 10.1016/j.ejheart.2003.11.022.
PubMed 15302005
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimated Physical Activity of Congestive Heart Failure Patients by a Physical Activity Questionnaire : Concordance Study.
- ClinicalTrials.gov ID
- NCT00676390
- Acronym / sponsor ID
- H2OBis / 0708046
- Conditions
- Congestive Heart Failure
- Keywords
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Mar 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 May 2008 (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 treatment and follow-up of congestive heart failure (CHF) represents a major part of France's health expenses. The beneficial effects of cardiac rehabilitation is well established, especially regarding the reduction of dyspnea, exercise limitation and fatigue and leads ultimately to a better quality of life. Maintaining these benefits in secondary prevention requires an improvement in daily physical activity, which is challenging and supposes a close follow-up difficult to perform on a daily living basis. However, a better knowledge of the type and dose of daily physical activity of this population would be very beneficial for the practitioner to prescribe or advise individually the type and the dose of physical activity required to maintain the benefits of cardiac rehabilitation. To date, only a physical activity questionnaire adapted to CHF could provide information regarding both the type and dose of daily physical activity. Such a questionnaire has been developed by our research team and allows an estimation of daily energy expenditure as well as the daily energy expended in its physical activity dimensions (rest, activities < 3 MET, activities between 3 and 5 MET, and activities > 5 MET). During its first step of validation, daily and physical activity energy expenditure estimated by this questionnaire was correlated to various factors of physical condition and notably, to peak V'O2 (R=0.71), prognostic factor largely recognized in CHF. A second step of validation was a pilot study comparing the estimation of daily energy expenditure by the questionnaire with a measurement of free-living daily energy expenditure with the doubly labelled water (DLW) method in 11 middle-aged males patients suffering CHF (NYHA I to III). Daily energy expenditure estimated from the questionnaire was very close to daily energy expenditure measured from the DLW method (R2 = 0.81; individual relative error < 7%). However, the high cost of the DLW method reduced the population studied to a small sample, which is a major limitation of this study since the sample was somewhat different to general CHF population in France.
Detailed description
Therefore, the aim of the present study was to assess the validity of the questionnaire against the DLW method in a larger population of 30 patients with CHF more representative of the general population with CHF, including men and women, NYHA I to IV, with a larger age panel. Along with this concordance study, a measurement of the energy cost of specific physical activities of daily life is performed with an ambulatory gaz analyzer method to further validate the calculation method of daily energy expenditure from the questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: doubly labelled water and questionnaireCongestive Heart failure patients |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Congestive Heart Failure
- Stade II, III of NYHA
- Between 20 to 80 years old
- EF < 45%
- Written informed consent
Key exclusion criteria (3 listed)
- Corticotherapy
- Thyroid dysfunction
- Cachectic status
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 |
|---|---|---|
| doubly labelled water and questionnaire0.075 g.kg-1 and 2H2O et 0.15 g.kg-1 de H218O per oral at inclusion visit. physical activity questionnaire at inclusion visit | Other | 1 |
Primary outcome
To validate a physical activity questionnaire adapted to congestive heart failure patients by the questionnaire comparing with a measurement of free-living daily energy expenditure with the doubly labelled water.
Time frame: D14 visit
1 secondary outcome
To determinate the energy cost of specific physical activities of daily life performed with an ambulatory gaz analyzer method
Time frame: D14 visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2013.
- Background: PubMed 15302005Garet M, Barthelemy JC, Degache F, Costes F, Da-Costa A, Isaaz K, Lacour JR, Roche F. A questionnaire-based assessment of daily physical activity in heart failure. Eur J Heart Fail. 2004 Aug;6(5):577-84. doi: 10.1016/j.ejheart.2003.11.022.
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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.
Frederic ROCHE, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing doubly labelled water and questionnaire in people with Congestive Heart Failure, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 28 Oct 2013. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate a physical activity questionnaire adapted to congestive heart failure patients by the questionnaire comparing with a measurement of free-living daily energy expenditure with the doubly labelled water. (time frame: D14 visit). 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 NCT00676390, 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 28 Oct 2013.