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Aged 60 Years or OlderNCT06646380

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

A study testing Multicomponent Training and Maintenance in people with Aged 60 Years or Older and Aged Healthy Volunteer, run by Instituto Politécnico de Bragança at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Multicomponent Training and Maintenance
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 sitePortugal
Study dates
15 Sep 2023to 15 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • Instituto Politécnico de Bragança

    Bragança, Braganza District, 5300-253

Other trials in Portugal

About this study

Official title: 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.

Read the 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.

Being tested
Multicomponent Training, Maintenance
Keywords
aged, physical fitness, body composition, sleep quality
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multicomponent TrainingBehavioural

    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

  • MaintenanceOther

    Participants were instructed to maintain daily life activities regarding physical activity.

Study groups in NCT06646380
Study groupRoleWhat they receive
Multicomponent TrainingExperimentalParticipants 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.
Receives: Behavioral: Multicomponent Training
Control GroupPlacebo comparatorThe 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).
Receives: Other: Maintenance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline (0 weeks) and at 32 weeks

Secondary outcomes (16)
  1. Handgrip strength

    Handgrip strength was assessed using a digital with the maximum kilograms-force (kgf)

    Measured: At baseline (0 weeks) and at 32 weeks

  2. 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.

    Measured: At baseline (0 weeks) and at 32 weeks

  3. 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.

    Measured: At baseline (0 weeks) and at 32 weeks

  4. Arm Curl Test

    The Arm Curl Test, using a 2 kg dumbbell to perform elbow curls for 30 seconds.

    Measured: At baseline (0 weeks) and at 32 weeks

  5. 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.

    Measured: At baseline (0 weeks) and at 32 weeks

  6. Sit and Reach Test

    The Sit and Reach Test, conducted while seated on a 43 cm chair with one leg extended and toes reached

    Measured: At baseline (0 weeks) and at 32 weeks

  7. Back Scratch Test

    The Back Scratch Test, where participants attempted to touch one hand with the other behind their back (cm)

    Measured: At baseline (0 weeks) and at 32 weeks

  8. Five-time sit-to-stand

    The five-time sit-to-stand test (sg)

    Measured: At baseline (0 weeks) and at 32 weeks

  9. Body Mass

    Body Mass (Kg)

    Measured: At baseline (0 weeks) and at 32 weeks

  10. Wist circumference

    Waist circumference (cm) perimeter.

    Measured: At baseline (0 weeks) and at 32 weeks

  11. Hip circumference

    Hip circumference (cm) perimeter

    Measured: At baseline (0 weeks) and at 32 weeks

  12. Total Fat

    Total Fat in Kg and Percentage (%).

    Measured: At baseline (0 weeks) and at 32 weeks

  13. Body Water

    Body Water (%)

    Measured: At baseline (0 weeks) and at 32 weeks

  14. Visceral Fa (a.u.)

    Visceral Fat (a.u.) in levels.

    Measured: At baseline (0 weeks) and at 32 weeks

  15. Basal Metabolic Rate

    Basal Metabolism (Kcal)

    Measured: At baseline (0 weeks) and at 32 weeks

  16. Body Mass Index (BMI)

    weight and height will be combined to report BMI in kg/m^2

    Measured: At baseline (0 weeks) and at 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2024
  2. Study start15 Sep 2023
  3. Primary completion30 Jun 2024
  4. Study completion15 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06646380
Sponsor's protocol ID
501020
Status last verified
Oct 2024
First submitted
9 Oct 2024
Last updated
17 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 37092426
  • 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.

    PubMed 36837572

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent Training and Maintenance in people with Aged 60 Years or Older and Aged Healthy Volunteer, run by Instituto Politécnico de Bragança at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Quality (time frame: At baseline (0 weeks) and at 32 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06646380, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.

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