Implementation and Effectiveness of a Community-based Exercise on Prescription Program for Adults With Chronic Diseases

Physical Activity Clinical Trial

— SSOCaen  

Official title:

Implementation and Effectiveness of a Community-based Exercise on Prescription Program for Adults With Chronic Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04919889
• Other study ID #: SSOCaen
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: September 10, 2020

Study information

• Verified date: June 2021
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objectives were (1) to evaluate the characteristics of the patients referred, and (2) the effect of a community-based Exercise on Prescription program on their physical capacities and their quality of life.

The program consisted in 30 supervised physical activity (PA) group sessions (75 min) over a 4-month period and participant were prescribed the program by their doctors.

The participants had chronic diseases among type 2 diabetes, mental disorders, musculoskeletal disorders, childhood and adult obesity and stabilized cardiovascular diseases.

Tests and questionnaires were completed before and after the program. Physical tests were the 6-minute walk test, the timed up & go, the 30-s stand up chair, the single leg support test and the back scratch and toe-touch tests. Questionnaires were the self-administered Ricci and Gagnon questionnaire about PA level and the 12-Item Short Form Survey for measuring quality of life.

Personal goal from the participants and medical objective from their doctors were collected before the program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: September 10, 2020
• Est. primary completion date: January 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All participant referred to the Exercise on Prescription Program (Caen)

Exclusion Criteria:

• French language not sufficiently read and/or spoken

• Lack of clear information on the study

• Alteration of higher functions or sensory disturbance making understanding and adherence to the research protocol impossible.

Related Conditions & MeSH terms

• Chronic Disease
• Physical Activity
• Prescription

Intervention

Other:
• Exercise prescription
All individuals referred to the community-based Exercise on Prescription program

Locations

Country	Name	City	State
France	CHU Caen Normandie	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6MWT	The six minute walking test (distance in meters)	Change from Baseline 6MWT at the end of the program (4 months)
Primary	TUG	The Timed up and Go (time in seconds)	Change from Baseline TUG at the end of the program (4 months)
Primary	30s Stand Up Chair	number of times the patient comes to a full standing position in 30 seconds (n)	Change from Baseline 30s Stand Up Chair at the end of the program (4 months)
Primary	single leg stance test	length of time standing on one foot, right and left	Change from Baseline single leg stance test at the end of the program (4 months)
Primary	left back scratch	Distance between one hand over the shoulder with the palm touching the back down and the other hand up the back from the waist with the palm facing outwards (in centimeters)	Change from Baseline left back scratch at the end of the program (4 months)
Primary	toe-touch test	Distance from the fingers to the floor whil the participant is bending from the hips forward and try to touch the ends of the fingers to the tips of the toes	Change from Baseline toe-touch test at the end of the program (4 months)
Primary	Ricci & Gagnon	self-administered Ricci and Gagnon questionnaire about physical activity profile (score over 45, greater for higher levels of physical activity)	Change from Baseline Ricci & Gagnon at the end of the program (4 months)
Primary	SF12	the 12-Item Short Form Survey (SF-12) for measuring quality of life, population mean 50; range 0-100, greater scores for better quality of life	Change from Baseline SF12 at the end of the program (4 months)
Primary	Personal Goal	Personal goal from the participants were collected	Achievement of personal goal at the end of the program (4 months)
Primary	Medical objective	Medical objective from the participants' doctors were collected	Achievement of medical goal at the end of the program (4 months)
Secondary	Address	Individuals were asked whether or not they lived in priority areas	One assessment at the beginning, At enrollment
Secondary	Age	Individuals were asked about their age	One assessment at the beginning, At enrollment
Secondary	Body mass	Body mass (kg) was measured	One assessment at the beginning, At enrollment
Secondary	Height	Height (cm) was measured	One assessment at the beginning, At enrollment
Secondary	Chronic condition	The chronic condition for which individuals had been referred to the exercise program was collected.	One assessment at the beginning, At enrollment