Characteristic and Real Intensity of Exercise in a Hospital-based Physical Activity Protocol for Patients With Chronic Disease

The objective is to better characterize an adapted physical activity (APA) program within of the management of chronic diseases.

In France, since 2016, medical doctors have been able to prescribe APA to their patients with chronic diseases but while there are indeed prescription recommendations, there is no clear characterization of the practical reality of APA programs.

The interest of this work is to benefit from the experience of the Center of Sports Medicine and Adapted Physical Activities in Nancy (France) specifically dedicated to the prescription and the initiation of an APA program for of patients with a chronic disease.

Thus, this work aims to determine the real intensity of the APA, the effectiveness of the assessment necessary for the dispensation of the APA and other parameters likely to modify the result of the treatment.

Study Overview

• Status: Completed
• Conditions: Physical Inactivity
• Intervention / Treatment: Other: Heart Rate Recording

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• France
  • Vandoeuvre les nancy, France, 54500
    • Centre Hospitalier Régional Universitaire de Nancy.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is a cross-sectional monocentric study performed at the Nancy University Center of Sports Medicine and APA, France, between February 2020 and July 2021, in patients requiring implementation of APA.

Description

Inclusion Criteria:

- age greater than 18 years old, with the ability to perform a cardiopulmonary exercise test

Exclusion Criteria:

• beta-blocker treatment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No limitation of exercise performance capacities; normal maximal oxygen uptake (greater than or equal to 80% of the reference value)	Other: Heart Rate Recording; During the APA session, HR was digitized at 1Hz (using custo guard, Custo Med GmbH). The ratio between the APA session HR and exercise test HRpeak was used to assess the intensity of effort.
Limitation of exercise performance capacities; reduced maximal oxygen uptake (less than 80% of the reference value).	Other: Heart Rate Recording; During the APA session, HR was digitized at 1Hz (using custo guard, Custo Med GmbH). The ratio between the APA session HR and exercise test HRpeak was used to assess the intensity of effort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the real intensity level of adapted physical activity (APA).	evaluate the real intensity level of exercise in a sample of patients with chronic disease involved in a hospital-based program of adapted physical activity (APA).	Heart rate mean during 1 hour in the first APA Session (cross-sectional monocentric study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Six-Minute Walk Test (6-MWT) efficacity to determine physical activity capacities	evaluate Six-Minute Walk Test (6-MWT) efficacity to determine physical activity capacities for patients with chronic disease.	6 minutes in the first APA Session (cross-sectional monocentric study)
Evaluate sit-to-stand test (1 minute)) efficacity to determine physical activity capacities	Evaluate sit-to-stand test (1 minute)) efficacity to determine physical activity capacitiesfor patients with chronic disease.	1 minute in the first APA Session (cross-sectional monocentric study)

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: exercise; Chronic disease; Adapted Physical activity
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 2021-PI191

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No