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.
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
- Conditions the study is for
- Aged 60 Years or Older, Aged Healthy Volunteer
- What is being tested?
- Multicomponent Training and Maintenance
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Aged 60 Years or Older, Aged Healthy Volunteer
- 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 group | Role | What they receive |
|---|---|---|
| Multicomponent Training | Experimental | 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. Receives: Behavioral: Multicomponent Training |
| Control Group | Placebo comparator | 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). Receives: Other: Maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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-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
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
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
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
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
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
Five-time sit-to-stand
The five-time sit-to-stand test (sg)
Measured: At baseline (0 weeks) and at 32 weeks
Body Mass
Body Mass (Kg)
Measured: At baseline (0 weeks) and at 32 weeks
Wist circumference
Waist circumference (cm) perimeter.
Measured: At baseline (0 weeks) and at 32 weeks
Hip circumference
Hip circumference (cm) perimeter
Measured: At baseline (0 weeks) and at 32 weeks
Total Fat
Total Fat in Kg and Percentage (%).
Measured: At baseline (0 weeks) and at 32 weeks
Body Water
Body Water (%)
Measured: At baseline (0 weeks) and at 32 weeks
Visceral Fa (a.u.)
Visceral Fat (a.u.) in levels.
Measured: At baseline (0 weeks) and at 32 weeks
Basal Metabolic Rate
Basal Metabolism (Kcal)
Measured: 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
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.
- First posted17 Oct 2024
- Study start15 Sep 2023
- Primary completion30 Jun 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aged 60 Years or OlderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Bragança
- Sponsor type
- University, hospital or other
- Collaborators
- Research Center for Active Living and Wellbeing, University of Alcala
- Responsible party
- Principal investigator, Pedro Miguel Gomes Forte, University of Alcala
- Investigators
- Pedro Miguel Forte, PhD, Principal investigator, University of Alcala
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 37092426Rodrigues 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of the Interplay Between Physical Fitness, Sleep Quality, Dynamic Balance and Exercise Intervention in Aged People
- ClinicalTrials.gov ID
- NCT06646380
- Acronym / sponsor ID
- 501020
- Conditions
- Aged 60 Years or Older, Aged Healthy Volunteer
- Keywords
- aged, physical fitness, body composition, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto Politécnico de BragançaUniversity, hospital or other
- Collaborators
- Research Center for Active Living and Wellbeing, University of Alcala
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Training | Experimental | Behavioral: Multicomponent TrainingParticipants 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. |
| Control Group | Placebo comparator | Other: MaintenanceThe 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent TrainingThe 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 | Behavioural | Multicomponent Training |
| MaintenanceParticipants were instructed to maintain daily life activities regarding physical activity. | Other | Control Group |
Primary outcome
Sleep Quality
Time frame: At baseline (0 weeks) and at 32 weeks
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.
16 secondary outcomes
Handgrip strength
Time frame: At baseline (0 weeks) and at 32 weeks
2-Minute Step Test
Time frame: At baseline (0 weeks) and at 32 weeks
The Seat-to-Stand Test
Time frame: At baseline (0 weeks) and at 32 weeks
Arm Curl Test
Time frame: At baseline (0 weeks) and at 32 weeks
Time-Up-and-Go Test
Time frame: At baseline (0 weeks) and at 32 weeks
Sit and Reach Test
Time frame: At baseline (0 weeks) and at 32 weeks
Back Scratch Test
Time frame: At baseline (0 weeks) and at 32 weeks
Five-time sit-to-stand
Time frame: At baseline (0 weeks) and at 32 weeks
Body Mass
Time frame: At baseline (0 weeks) and at 32 weeks
Wist circumference
Time frame: At baseline (0 weeks) and at 32 weeks
Hip circumference
Time frame: At baseline (0 weeks) and at 32 weeks
Total Fat
Time frame: At baseline (0 weeks) and at 32 weeks
Body Water
Time frame: At baseline (0 weeks) and at 32 weeks
Visceral Fa (a.u.)
Time frame: At baseline (0 weeks) and at 32 weeks
Basal Metabolic Rate
Time frame: At baseline (0 weeks) and at 32 weeks
Body Mass Index (BMI)
Time frame: At baseline (0 weeks) and at 32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Background: PubMed 37092426Solis-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.
- Background: PubMed 36837572Rodrigues 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Miguel Forte, PhD principal investigator
University of Alcala
1 site in 1 country: see every site and its status.
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.