The effect of physical activity monitoring awareness on physical activity levels and sleep habits: a crossover randomised controlled trial.

Not Applicable

• Conditions: F06.7; Mild cognitive disorder

• Registration Number: DRKS00023446
• Lead Sponsor: Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-12-22
• Study Start: 2020-10-29
• Results First Posted: 2021-12-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Result of the Montreal Cognitive Assessment test:19-30 points; Living in a community-dwelling

Exclusion Criteria

Depression and/or the results Hamilton depression test > 13 points; The use of cognitive-enhancing medications or psychotropic medications; Substance abuse disorders (e.g. alcohol - >15 drinks (units)/week); Diagnosed mental disorders, Parkinson’s disease Alzheimer’s disease, dementia; Diabetes for >10 years; Chronic renal and liver diseases; History of cancer within the past 5 years; History of stroke; Current evidence or history in the past 2 years of seizures, head injury with loss of consciousness and/or immediate confusion after the injury; Hypothyroidism with current out of reference range TSH levels; Any chronic diseases that might have limited training and testing of the cardiovascular and respiratory systems; Current vigorous physical activity for more than 75 min/week or equivalent as revealed by a questionnaire or physician’s examination; Loss of sight or hearing, language difficulties or any other disability which may prevent the subjects from participating or cooperating in the protocol.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences between study arms in the physical activity levels measured by the ActiGraph monitor (number of steps per day, active calories, metabolic equivalent rate, time in sedentary, light, moderate, vigorous, very vigorous, moderate-to-vigorous physical activity).

Secondary Outcome Measures

Name	Time	Method
Differences between study arms in the following parameters: 1)energy expenditure as measured by 13C bicarbonate breathing test (Wagner, Iris); 2) resting metabolic rate measured by indirect calorimetry (Cosmed, Italy); 3) total physical activity (MET-minutes/week), moderate (MET-minutes/week and minutes/week) and vigorous (MET-minutes/week and minutes/week) activity and time spend sitting (minutes/week) measured by the International Physical Activity Questionnaire (IPAQ); 4) sleep parameters (sleep efficiency, average latency, average total sleep time, average wake time after sleep onset, the average number of awakenings, average length of awakenings in minutes, average movement index, average fragmentation index) measured by the ActiGraph monitor (ActiGraph, LLC, Pensacola, Florida, USA).<br>