Implementation of a 12-week Adapted Physical Activity (APA) Program in People Suffering From Chronic Insomnia.

NCT05294133 | Unknown

• 1 other identifier: 2021-A00862-39
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

One third of men and women are not satisfied with their sleep. A non-drug countermeasure to improve sleep in insomniacs could be adapted physical activity (APA). However, research is needed because the literature is limited and the few studies are most often based on subjective data with a great methodological disparity. Within the framework of the care pathway of Dr ARON's patients, sleep doctor at the Sommeil Morphée Center of the Grande Synthe Polyclinic (59), the objective of this project is to make an APA program more reliable in order to improve sleep, to understand the underlying mechanisms and to include APA in the therapeutic management.

Conditions

Exercise; Health Behavior; Sleep

Outcome Measures

Primary Outcomes (2)

• subjective sleep change

  questionnaire insomnia severity index. The minimum score is 0 and the maximum is 28. Higher scores mean a worse outcome. A score higher than 14 is considered as a person with clinical insomnia.

  before and after the 12 weeks

• objective sleep change

  Participants were fitted with an accelerometer on their wrist (non-dominant arm) for 7 days to assess the quantity and quality of their sleep

  before and after the 12 weeks

Secondary Outcomes (5)

• circadian rythm change

  before and after the 12 weeks

• objective stress change

  before and after the 12 weeks

• hearth rate variability change

  before and after the 12 weeks

• physical capacity change

  before and after the 12 weeks

• subjective stress change

  before and after the 12 weeks

Study Arms (2)

control group

NO INTERVENTION

no intervention

physical activity

EXPERIMENTAL

Behavioral: physical activity

Interventions

physical activity BEHAVIORAL

physical activity

physical activity

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 18 to 60 with chronic insomnia (according to the 5 criteria of the Diagnostic and Statistical Manual) without any other associated sleep pathology (sleep apnea, restless legs syndrome, etc.)

You may not qualify if:

• Medical contraindication to physical activity Associated serious medical pathologies (cancer...) Night work, jet lag during the last month, young children BMI\> 30 Current use or \<3 months of psychoactive, hypnotic, stimulant or analgesic medications Alcohol or drug abuse

Sponsors & Collaborators

• Universite du Littoral Cote d'Opale: lead

Study Sites (1)

University of littoral cote d'ople

Dunkirk, France

RECRUITING

MeSH Terms

Conditions

Motor Activity; Health Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Pauline BARON, Phd Student

CONTACT

0673681126; pauline_baron@orange.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: March 24, 2022
• Study Start: September 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)