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Estimated Physical Activity of Congestive Heart Failure Patients by a Physical Activity Questionnaire (H2OBis)

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
doubly labelled water and questionnaire
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congestive Heart Failure focused on measuring Heart Failure

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Congestive Heart Failure
  • Stade II, III of NYHA
  • Between 20 to 80 years old
  • EF < 45%
  • Written informed consent
  • French language

Exclusion Criteria:

  • Corticotherapy
  • Thyroid dysfunction
  • Cachectic status

Sites / Locations

  • Service de Physiologie Clinique et de l'Exercice, CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Congestive Heart failure patients

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To determinate the energy cost of specific physical activities of daily life performed with an ambulatory gaz analyzer method

Full Information

First Posted
May 9, 2008
Last Updated
October 25, 2013
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00676390
Brief Title
Estimated Physical Activity of Congestive Heart Failure Patients by a Physical Activity Questionnaire
Acronym
H2OBis
Official Title
Estimated Physical Activity of Congestive Heart Failure Patients by a Physical Activity Questionnaire : Concordance Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Heart Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Congestive Heart failure patients
Intervention Type
Other
Intervention Name(s)
doubly labelled water and questionnaire
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To determinate the energy cost of specific physical activities of daily life performed with an ambulatory gaz analyzer method
Time Frame
D14 visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Congestive Heart Failure Stade II, III of NYHA Between 20 to 80 years old EF < 45% Written informed consent French language Exclusion Criteria: Corticotherapy Thyroid dysfunction Cachectic status
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic ROCHE, MD
Organizational Affiliation
CHU de Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Physiologie Clinique et de l'Exercice, CHU de Saint-Etienne
City
Saint-etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15302005
Citation
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.
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Estimated Physical Activity of Congestive Heart Failure Patients by a Physical Activity Questionnaire

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