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

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.

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Other: doubly labelled water and questionnaire

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • Service de Physiologie Clinique et de l'Exercice, CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	D14 visit

Secondary Outcome Measures

Outcome Measure	Time Frame
To determinate the energy cost of specific physical activities of daily life performed with an ambulatory gaz analyzer method	D14 visit

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Frederic ROCHE, MD, CHU de SAINT-ETIENNE

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: May 9, 2008
• First Submitted That Met QC Criteria: May 9, 2008
• First Posted (Estimate): May 13, 2008

Study Record Updates

• Last Update Posted (Estimate): October 28, 2013
• Last Update Submitted That Met QC Criteria: October 25, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Heart Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 0708046; 2007- A00615-48 (Other Identifier: AFSSAPS); DGS 2007-0434 (Other Identifier: DGS)