NCT04919889

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2018

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
Last Updated

March 26, 2025

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

May 8, 2021

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (10)

  • 6MWT

    The six minute walking test (distance in meters)

    Change from Baseline 6MWT at the end of the program (4 months)

  • TUG

    The Timed up and Go (time in seconds)

    Change from Baseline TUG at the end of the program (4 months)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • Personal Goal

    Personal goal from the participants were collected

    Achievement of personal goal at the end of the program (4 months)

  • Medical objective

    Medical objective from the participants' doctors were collected

    Achievement of medical goal at the end of the program (4 months)

Secondary Outcomes (5)

  • Address

    One assessment at the beginning, At enrollment

  • Age

    One assessment at the beginning, At enrollment

  • Body mass

    One assessment at the beginning, At enrollment

  • Height

    One assessment at the beginning, At enrollment

  • Chronic condition

    One assessment at the beginning, At enrollment

Interventions

All individuals referred to the community-based Exercise on Prescription program

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the individuals who were addressed to the municipally-based exercise on prescription program "Sport sur Ordonnance"

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Caen Normandie

Caen, 14000, France

Location

MeSH Terms

Conditions

Motor ActivityChronic Disease

Condition Hierarchy (Ancestors)

BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2021

First Posted

June 9, 2021

Study Start

September 1, 2017

Primary Completion

January 20, 2018

Study Completion

September 10, 2020

Last Updated

March 26, 2025

Record last verified: 2021-06

Locations