Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646380
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Physical Fitness Sleep Quality Dynamic Balance and Exercise in Aged People
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Importance of the Interplay Between Physical Fitness Sleep Quality Dynamic Balance and Exercise Intervention in Aged People
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nowadays the sedentary lifestyles and aging related problem to well-being have a significant impact on of physical fitness quality of life and sleep in elderlies The regular exercise is of higher importance crucial for maintaining overall health and delay some ageing-related declines in physical fitness The multicomponent training MCT programs include exercises to promote endurance strength flexibility and balance The MCT are typically effective to improve physical fitness quality of life sleep and balance in older populations Notably in visually impaired older adults lower limb function is closely linked to fall risk Improving the muscular strength and bone health enhances the balance and the gait Additionally it is possible to find associations between sleep quality frailty and quality of life among older adults highlighting the interplay between sleep physical health and overall well-being in aging populations Another study highlighted that the socioeconomic status and sleep qualitys influence on the prevalence of multimorbidity in older adults underscoring the broader health implications of sleep disturbances in aging populations
The principal objective of the current PhD research project is to assess the effects of a multicomponent training programs on critical variables such as physical fitness sleep quality and dynamic balance in older adults
The principal objective of the current PhD research project is to assess the effects of a multicomponent training programs on critical variables such as physical fitness sleep quality and dynamic balance in older adults
Detailed Description:
To successfully close this research project and in agreement with the stablished objectives and hypothesis a compendium of three future published articles as part of the thesis The first article will be a review about the relationships between exercise sleep quality physical fitness and dynamic balance This review article will answer the first hypothesis and objective The second article will be an observational research article The data from the baseline evaluation will allow to run artificial intelligence algorithms intending to predict the dynamic balance variance based on physical fitness and quality of sleep This article aims to identify the variables that mostly explain the dynamic balance based on body composition and antropometrics sleep quality and physical fitness This article will answer to the second hypothesis and objective The third article will be a randomized controlled trial article This part of the research will seek to understand the effects of 8 months multicomponent exercise training program in antropometric and body composition sleep quality physical fitness effects and dynamic balance
Study design The present project will adopt a longitudinal approach wherein volunteers will be briefed about the study objectives and protocol and were required to provide informed consent adhering to the Helsinki Declaration guidelines Participants were instructed to maintain normal daily life activities to prevent physical inactivity Inclusion criteria will involve individuals over 65 years old independent in daily activities and without chronic diseases requiring pharmacological treatment affecting the experimental protocol while exclusion criteria included failure to attend more than 25 of training sessions failure to attend more than four consecutive sessions or missing evaluation sessions Participants will be randomly assigned to either the experimental group EG 30 or control group CG 30 The multicomponent training MCT program comprised aerobic resistance flexibility and balance exercises Sessions lasted 50 to 60 minutes including warm-up aerobic exercise resistance training balance training and cool-down Training intensity gradually increased over time The experimental group will have three 60-minute sessions weekly for 32 weeks while the control group will not participate in any exercise program but they will maintain the daily physical activity Both groups will be evaluated at two time points initial assessment M1 at the start of training and final assessment M2 after 32 weeks The Physical fitness will be assessed using the Rikli and Jones Senior Fitness Test The Sleep quality evaluated by the Pittsburgh Sleep Quality Index PSQI Dynamic balance will be assessed using the Timed Up and Go Test TUG Additionally body composition before and after the training program will be evaluated by bioimpedance
Physical Fitness The Rikli and Jones Senior Fitness Test will be used to assess the physical fitness The following tests will be used limb strength and endurance of lower 30-s chair stand and seat by the number of repetitions and upper limbs arm curl with 2 kg dumbbell lower flexibility chair sit-and-reach in centimeters and superior flexibility back scratch in centimeters physical mobility speed agility and dynamic balance stand up the chair and run 8-ft up-and-go returning and seat on the chair measured in seconds and aerobic endurance 2 min step test rising and counting the repetitions when the knee reaches the hip level
Sleep Quality The Pittsburgh Sleep Quality Index PSQI will be used to assess the sleep quality This instrument consists in a set of 19 self-reported questions is divided into seven subcategories covering various aspects of sleep experience such as perceived sleep quality time taken to fall asleep duration of sleep efficiency of sleep disturbances during sleep use of sleep aids and daytime functionality
Additionally five extra questions assessed by the respondents roommate or bed partner are included for clinical assessment but do not contribute to the scoring process The instruments psychometric properties using a sample of individuals ranging in age from 24 to 83 years There are some literature that examined the psychometric characteristics of the scale the developers initial assessment revealed an internal reliability of α 83 a test-retest reliability of 85 for the overall scale with a sensitivity of 896 and a specificity of 865
Dynamic Balance The Timed Up and Go Test TUG will be used to assess the dynamic balance The individuals will start in a seated position in a chair with armrests Upon receiving a verbal cue they stand up walk approximately 3 meters 10 feet at their usual pace turn around walk back to the chair and sit down again This test evaluates dynamic balance by measuring the time taken in seconds to complete the task reflecting the individuals ability to transition between sitting and standing walk safely turn and return to a seated position which is indicative of their dynamic balance and mobility Interpretation of the results is based on the completion time where shorter times suggest better dynamic balance and mobility while longer times may indicate limitations in balance and mobility Typically measured in seconds cutoff values for the TUG test may vary depending on factors such as age and health status but shorter completion times generally signify better dynamic balance and mobility with completion times of approximately 10 seconds or less considered indicative of good functional mobility and balance in older adults
Study design The present project will adopt a longitudinal approach wherein volunteers will be briefed about the study objectives and protocol and were required to provide informed consent adhering to the Helsinki Declaration guidelines Participants were instructed to maintain normal daily life activities to prevent physical inactivity Inclusion criteria will involve individuals over 65 years old independent in daily activities and without chronic diseases requiring pharmacological treatment affecting the experimental protocol while exclusion criteria included failure to attend more than 25 of training sessions failure to attend more than four consecutive sessions or missing evaluation sessions Participants will be randomly assigned to either the experimental group EG 30 or control group CG 30 The multicomponent training MCT program comprised aerobic resistance flexibility and balance exercises Sessions lasted 50 to 60 minutes including warm-up aerobic exercise resistance training balance training and cool-down Training intensity gradually increased over time The experimental group will have three 60-minute sessions weekly for 32 weeks while the control group will not participate in any exercise program but they will maintain the daily physical activity Both groups will be evaluated at two time points initial assessment M1 at the start of training and final assessment M2 after 32 weeks The Physical fitness will be assessed using the Rikli and Jones Senior Fitness Test The Sleep quality evaluated by the Pittsburgh Sleep Quality Index PSQI Dynamic balance will be assessed using the Timed Up and Go Test TUG Additionally body composition before and after the training program will be evaluated by bioimpedance
Physical Fitness The Rikli and Jones Senior Fitness Test will be used to assess the physical fitness The following tests will be used limb strength and endurance of lower 30-s chair stand and seat by the number of repetitions and upper limbs arm curl with 2 kg dumbbell lower flexibility chair sit-and-reach in centimeters and superior flexibility back scratch in centimeters physical mobility speed agility and dynamic balance stand up the chair and run 8-ft up-and-go returning and seat on the chair measured in seconds and aerobic endurance 2 min step test rising and counting the repetitions when the knee reaches the hip level
Sleep Quality The Pittsburgh Sleep Quality Index PSQI will be used to assess the sleep quality This instrument consists in a set of 19 self-reported questions is divided into seven subcategories covering various aspects of sleep experience such as perceived sleep quality time taken to fall asleep duration of sleep efficiency of sleep disturbances during sleep use of sleep aids and daytime functionality
Additionally five extra questions assessed by the respondents roommate or bed partner are included for clinical assessment but do not contribute to the scoring process The instruments psychometric properties using a sample of individuals ranging in age from 24 to 83 years There are some literature that examined the psychometric characteristics of the scale the developers initial assessment revealed an internal reliability of α 83 a test-retest reliability of 85 for the overall scale with a sensitivity of 896 and a specificity of 865
Dynamic Balance The Timed Up and Go Test TUG will be used to assess the dynamic balance The individuals will start in a seated position in a chair with armrests Upon receiving a verbal cue they stand up walk approximately 3 meters 10 feet at their usual pace turn around walk back to the chair and sit down again This test evaluates dynamic balance by measuring the time taken in seconds to complete the task reflecting the individuals ability to transition between sitting and standing walk safely turn and return to a seated position which is indicative of their dynamic balance and mobility Interpretation of the results is based on the completion time where shorter times suggest better dynamic balance and mobility while longer times may indicate limitations in balance and mobility Typically measured in seconds cutoff values for the TUG test may vary depending on factors such as age and health status but shorter completion times generally signify better dynamic balance and mobility with completion times of approximately 10 seconds or less considered indicative of good functional mobility and balance in older adults
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None