Viewing Study NCT06486961



Ignite Creation Date: 2024-07-17 @ 11:35 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06486961
Status: RECRUITING
Last Update Posted: 2024-07-12
First Post: 2024-06-27

Brief Title: Effect of Walking With Music in Obese People BeatMove
Sponsor: Clinique Beau Soleil
Organization: Clinique Beau Soleil

Study Overview

Official Title: Randomized Controlled Study of the Effectiveness of a Self-rehabilitation Program for Walking Using Adapted Musical Auditory Rhythmic Stimulation Delivered by BeatMove in People Suffering From Obesity
Status: RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BeatMove
Brief Summary: For several decades scientists have reported encouraging effects of physical activity on functional capacities and quality of life among patients with obesity However regular daily physical activity remains limited in these individuals People with obesity generally show lower adherence to physical activity with 40 not meeting the recommendations of 25 to 3 hours of moderate physical activity per week set by the French National Authority for Health to be considered physically active Since physical activity is the primary energy expenditure that can be targeted the priority is to make it appealing through exercise programs tailored to individual needs abilities and preferences To achieve this using music to facilitate walking appears relevant Studies show that individuals adhere to physical activity and incorporate it into their routines only if they find it enjoyable Walking to music is more motivating and enjoyable Moreover the rhythm of music enhances the functioning of biological systems involved in walking Tailored physical activity is a major preventive lever to implement for individuals with obesity It is essential during the initial weight loss phase and during weight maintenance

The overall objective of this study is to propose a digital tool capable of modifying the behavior of individuals with obesity to reduce sedentary behavior in their daily lives Synchronized walking to the rhythm of music should help train obese patients towards a virtuous cycle leading to slowed weight gain reduced associated health problems and improvements in mental health and quality of life
Detailed Description: This program involves outdoor walking sessions conducted 5 times a week for 15 to 30 minutes each over a consecutive 3-month period using the BeatMove device The device can be adjusted to deliver music or not and the music can either be synchronized to the participants walking pace or randomly timed

During the week preceding self-rehabilitation participants will wear a thigh-mounted accelerometer to establish a baseline representative of their daily habits Before each walking session participants will assess their motivation using a visual analog scale within the application After each session they will evaluate their perceived exertion using the Borg Scale

In the BeatMove group the music delivered will be tailored to match the walking pace of the participants Throughout the session the music rhythm will subtly increase by 20 to accelerate the participants walking pace thereby guiding them towards their optimal cadence based on their assessed level and motivation at the start of the session

In the group with randomly timed music the music delivery does not consider the participants state and plays random music

Finally in the group without music the walking self-rehabilitation program will be guided solely by the audio instructions provided by the application

In all three groups participants will be equipped

Throughout the day with a thigh-mounted fibion sens accelerometer During the walking self-rehabilitation session with ankle step sensors to record walking parameters while delivering music tailored to their walking pace

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None