Physical Fitness, Sleep Quality, Dynamic Balance and Exercise in Aged People

The Importance of the Interplay Between Physical Fitness, Sleep Quality, Dynamic Balance and Exercise Intervention in Aged People

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 quality's 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.

Study Overview

• Status: Completed
• Conditions: Aged Healthy Volunteer; Aged 60 Years or Older
• Intervention / Treatment: Behavioral: Multicomponent Training; Other: Maintenance

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 respondent's roommate or bed partner, are included for clinical assessment but do not contribute to the scoring process. The instrument's 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 89.6% and a specificity of 86.5%.

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 individual's 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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Bragança, Portugal, 5300-253
    • Instituto Politécnico de Bragança

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• being aged 60 years or older;
• maintaining functional independence in daily tasks;
• having no severe chronic diseases or medications to sleep that could affect the results:
• do not have significant cardiovascular, muscular, metabolic, or joint complications.

Exclusion Criteria:

• Less than 60 years old.
• Be dependent of caregiver in daily life activities.
• Use medication to sleep or tranquilizers.
• Have cardiovascular, muscular, metabolic or joint diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multicomponent Training; Participants will be 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). Experimental group will be followed-up during the exercise sessions.	Behavioral: Multicomponent Training; The multicomponent training (MCT) program comprised aerobic, resistance, flexibility, and balance exercises, following recommendations by Carvalho et al. (23). 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
Placebo Comparator: Control Group; The CG were instructed to maintain their daily life routines. However, the typical profile of this group was that the participants were regularly physically active people. Most participate in municipal activities like nature walking, physical activity sessions including dance (casually), board and card games, and traditional games (Bocce, Adapted Bowling, and darts).	Other: Maintenance; Participants were instructed to maintain daily life activities regarding physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire developed by and validated for the Portuguese population. The PSQI items are divided into the following components: 1) subjective sleep quality, 2) sleep latency, 3) sleep duration, 4) habitual sleep efficiency, 5) sleep disturbances, 6) use of sleeping medication, and 7) daytime dysfunction. Each item is scored from 0 to 3, with the total score ranging from 0 to 21; higher scores indicate more severe sleep disturbances. A global score of 5 or higher in two components signifies significant sleep difficulties, while a score in three or more components indicates moderate sleep issues. A total score below 5 indicates good sleep quality, whereas a score above 5 indicates poor sleep quality.	At baseline (0 weeks) and at 32 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip strength	Handgrip strength was assessed using a digital with the maximum kilograms-force (kgf)	At baseline (0 weeks) and at 32 weeks
2-Minute Step Test	The 2-Minute Step Test, where the evaluator set a knee height marker using a measuring tape to measure from the kneecap to the iliac crest, and participants aimed to take as many steps as possible in two minutes, with performance checks at 60 and 90 seconds.	At baseline (0 weeks) and at 32 weeks
The Seat-to-Stand Test	The The Seat-to-Stand Test required participants to repeatedly sit and stand from a 43 cm highchair for 30 seconds, recording the number of repetitions.	At baseline (0 weeks) and at 32 weeks
Arm Curl Test	The Arm Curl Test, using a 2 kg dumbbell to perform elbow curls for 30 seconds.	At baseline (0 weeks) and at 32 weeks
Time-Up-and-Go Test	The Time-Up-and-Go Test involved starting from a seated position on a 43 cm chair, walking quickly around a cone placed 2.44 meters away.	At baseline (0 weeks) and at 32 weeks
Sit and Reach Test	The Sit and Reach Test, conducted while seated on a 43 cm chair with one leg extended and toes reached	At baseline (0 weeks) and at 32 weeks
Back Scratch Test	The Back Scratch Test, where participants attempted to touch one hand with the other behind their back (cm)	At baseline (0 weeks) and at 32 weeks
Five-time sit-to-stand	The five-time sit-to-stand test (sg)	At baseline (0 weeks) and at 32 weeks
Body Mass	Body Mass (Kg)	At baseline (0 weeks) and at 32 weeks
Wist circumference	Waist circumference (cm) perimeter.	At baseline (0 weeks) and at 32 weeks
Hip circumference	Hip circumference (cm) perimeter	At baseline (0 weeks) and at 32 weeks
Total Fat	Total Fat in Kg and Percentage (%).	At baseline (0 weeks) and at 32 weeks
Body Water	Body Water (%)	At baseline (0 weeks) and at 32 weeks
Visceral Fa (a.u.)	Visceral Fat (a.u.) in levels.	At baseline (0 weeks) and at 32 weeks
Basal Metabolic Rate	Basal Metabolism (Kcal)	At baseline (0 weeks) and at 32 weeks
Body Mass Index (BMI)	weight and height will be combined to report BMI in kg/m^2	At baseline (0 weeks) and at 32 weeks

Collaborators and Investigators

• Sponsor: Instituto Politécnico de Bragança
• Collaborators: University of Alcala; Research Center for Active Living and Wellbeing
• Investigators: Principal Investigator: Pedro Miguel Forte, PhD, University of Alcala

Publications and helpful links

General Publications

• Solis-Navarro L, Masot O, Torres-Castro R, Otto-Yanez M, Fernandez-Jane C, Sola-Madurell M, Coda A, Cyrus-Barker E, Sitja-Rabert M, Perez LM. Effects on Sleep Quality of Physical Exercise Programs in Older Adults: A Systematic Review and Meta-Analysis. Clocks Sleep. 2023 Mar 23;5(2):152-166. doi: 10.3390/clockssleep5020014.
• Rodrigues F, Jacinto M, Figueiredo N, Monteiro AM, Forte P. Effects of a 24-Week Low-Cost Multicomponent Exercise Program on Health-Related Functional Fitness in the Community-Dwelling Aged and Older Adults. Medicina (Kaunas). 2023 Feb 15;59(2):371. doi: 10.3390/medicina59020371.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): September 15, 2024

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: body composition; aged; sleep quality; physical fitness
• Other Study ID Numbers: 501020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No