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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00676390
First received: May 9, 2008
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Congestive Heart Failure
Other: doubly labelled water and questionnaire

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Estimated Physical Activity of Congestive Heart Failure Patients by a Physical Activity Questionnaire : Concordance Study.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

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. [ Time Frame: D14 visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determinate the energy cost of specific physical activities of daily life performed with an ambulatory gaz analyzer method [ Time Frame: D14 visit ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: March 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Congestive Heart failure patients
Other: doubly labelled water and questionnaire
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676390

Locations
France
Service de Physiologie Clinique et de l'Exercice, CHU de Saint-Etienne
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Frederic ROCHE, MD CHU de Saint-Etienne
  More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00676390     History of Changes
Other Study ID Numbers: 0708046, 2007- A00615-48, DGS 2007-0434
Study First Received: May 9, 2008
Last Updated: October 25, 2013
Health Authority: France: Ministry of Health
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 11, 2014