Mild Cognitive Impairment (MCI)DigitalHEALNCT06722976
Digital Health and Exercise for Autonomous Longevity Program
A study testing Multicomponent exercise programs in people with Mild Cognitive Impairment (MCI) and Older People, run by University of Beira Interior at 1 site in Portugal.
Trial summary
Digital HEAL (Health and Exercise for Autonomous Longevity) is a multicomponent training program (combining concurrent training with cognitive stimulation) designed to promote physical fitness and cognitive function in older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Older People
- What is being tested?
- Multicomponent exercise programs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Nov 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male and female participants aged ≥ 65 years.
- A score of ≥ 3 on the Short Physical Performance Battery (SPPB).
- Willingness to participate in the training programs and collaborate with the research team.
- Ability to provide informed consent, either oral or written.
Who cannot join
- A score of ≤ 3 on the Short Physical Performance Battery (SPPB).
- Presence of severe comorbidities that would negatively impact participation in the training program.
- Presence of color blindness.
- Diagnosis of severe dementia or severe impairment across multiple dimensions of cognition, which would prevent participation in the training program.
- History of surgeries or fractures within the last 6 months.
- These criteria ensure that participants are suitable for the program and capable of engaging in the training sessions effectively.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Digital HEAL (Health and Exercise for Autonomous Longevity)
Digital HEAL (Health and Exercise for Autonomous Longevity) is a multicomponent training program (combining concurrent training with cognitive stimulation) designed to promote physical fitness and cognitive function in older adults. This program merges a community-based approach with a scientific research project aimed at comparing the effects of in-person and online concurrent training on cognitive function and functional capacity in this population.
The program is structured into three phases: (1) Initial Assessment; (2) Multicomponent Training Sessions; (3) Final Assessment.
Read more
- Initial Assessment The initial assessment will consist of physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).
- Multicomponent Training Sessions The multicomponent training sessions will last for 3 months, with a frequency of two sessions per week, each lasting 50 minutes, conducted in person at the institution.
- Final Assessment The final assessment will be identical to the initial assessment, comprising physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).
Expected Benefits The anticipated benefits for participants include significant improvements in physical fitness, with a particular emphasis on strength, balance, and motor autonomy, which play an essential role in fall prevention. Additionally, cognitive abilities such as orientation, memory, and brain plasticity are expected to improve. The program also aims to promote social interaction, reducing social isolation among older adults. Furthermore, the program will support participants\' maintenance within the institution, which helps preserve their routine and address mobility and accessibility limitations. This intervention will also help reduce costs and time for the institution.
Potential Risks The risks associated with participation in the program are similar to those inherent in any physical activity. However, the equipment and environment (floor type, lighting, temperature) are evaluated to ensure suitability for safe exercise at any age. The exercises are supervised by a qualified professional who takes special care to minimize exercise-related risks.
Read the detailed description
Digital HEAL (Health and Exercise for Autonomous Longevity) is a multicomponent training program (combining concurrent training with cognitive stimulation) designed to promote physical fitness and cognitive function in older adults. This program merges a community-based approach with a scientific research project aimed at comparing the effects of in-person and online concurrent training on cognitive function and functional capacity in this population.
The program is developed and implemented by the Department of Sports Sciences, the Faculty of Health Sciences, and the Department of Psychology and Education of the University of Beira Interior (UBI), in collaboration with the University of Turin. The principal investigator is Ricardo André Alves Bispo Madeira.
The program is structured into three phases: (1) Initial Assessment; (2) Multicomponent Training Sessions; (3) Final Assessment.
- Initial Assessment The initial assessment will consist of physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).
- Multicomponent Training Sessions The multicomponent training sessions will last for 3 months, with a frequency of two sessions per week, each lasting 50 minutes, conducted in person at the institution.
- Final Assessment The final assessment will be identical to the initial assessment, comprising physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).
Expected Benefits The anticipated benefits for participants include significant improvements in physical fitness, with a particular emphasis on strength, balance, and motor autonomy, which play an essential role in fall prevention. Additionally, cognitive abilities such as orientation, memory, and brain plasticity are expected to improve. The program also aims to promote social interaction, reducing social isolation among older adults. Furthermore, the program will support participants\' maintenance within the institution, which helps preserve their routine and address mobility and accessibility limitations. This intervention will also help reduce costs and time for the institution.
Potential Risks The risks associated with participation in the program are similar to those inherent in any physical activity. However, the equipment and environment (floor type, lighting, temperature) are evaluated to ensure suitability for safe exercise at any age. The exercises are supervised by a qualified professional who takes special care to minimize exercise-related risks.
Voluntary Participation and Confidentiality Participation in the program is entirely voluntary, and participants can withdraw at any time without any consequences. Confidentiality is guaranteed, with only the principal investigator, Ricardo André Alves Bispo Madeira, having access to personal data, which will always be coded and not disclosed. The collected data will be used strictly for academic purposes, with no commercial interests. Upon request, individual data can be provided to each participant, improving the assessment of their current condition.
Research Team
The team of researchers involved includes:
Dr. Maria da Assunção Vaz Patto (Associate Professor at the Faculty of Health Sciences, UBI, and researcher at the Health Sciences Research Center - CICS-UBI) Dr. Maria Dulce Leal Esteves (Lecturer in the Department of Sports Sciences and researcher at the Research Center for Sport, Health, and Human Development - CIDESD) Dr. Nuno Filipe Cardoso Pinto (Adjunct Assistant Professor at the Faculty of Health Sciences, UBI, and researcher at CICS-UBI) Ricardo André Alves Bispo Madeira (Ph.D. student in Sports Sciences)
Principal Investigator Signature
By signing this document, I confirm, on behalf of the research team, that I have conveyed all the information contained herein, explained it, and answered all questions and concerns raised by the participant and their family members.
- Conditions
- Mild Cognitive Impairment (MCI), Older People
- Being tested
- Multicomponent exercise programs
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exercise programsOther
The program is organized into three phases: (1) Initial assessment; (2) Multicomponent training sessions; (3) Final assessment.
- The initial assessment will consist of physical fitness tests (lasting around 1 hour) and Neuropsychological Assessment tests (lasting around 1.5 hours).
- The multicomponent training sessions will last 3 months, twice a week, 50 minutes each session.
- The final assessment will be the same as the initial assessment (physical fitness tests (about 1 hour) and Neuropsychological Assessment tests (about 1.5 hours).
| Study group | Role | What they receive |
|---|---|---|
| face-to-face | Experimental | The program is organized into three phases: (1) Initial assessment; (2) Multicomponent training sessions; (3) Final assessment.
1. The initial assessment will consist of physical fitness tests (lasting around 1 hour) and Neuropsychological Assessment tests (lasting around 1.5 hours).
2. The multicomponent training sessions will last 3 months, twice a week, 50 minutes each session, held in person at the institution.
3. The final assessment will be the same as the initial assessment (physical fitness tests (about 1 hour) and Neuropsychological Assessment tests (about 1.5 hours). Receives: Other: Multicomponent exercise programs |
| Synchronous distance (video call) | Experimental | The program is organized into three phases: (1) Initial assessment; (2) Multicomponent training sessions; (3) Final assessment.
1. The initial assessment will consist of physical fitness tests (lasting around 1 hour) and Neuropsychological Assessment tests (lasting around 1.5 hours).
2. The multicomponent training sessions will last 3 months, twice a week, 50 minutes each, carried out by video call.
3. The final assessment will be the same as the initial assessment (physical fitness tests (about 1 hour) and Neuropsychological Assessment tests (about 1.5 hours). Receives: Other: Multicomponent exercise programs |
| Control group | No intervention | In the control group, the participants take part in the training sessions, and the program is organized into two phases: (1) Initial assessment; (2) Final assessment. 1. The initial assessment will consist of physical fitness tests (lasting around 1 hour) and Neuropsychological Assessment tests (lasting around 1.5 hours). 2. The final assessment will be the same as the initial assessment (physical fitness tests (duration approx. 1h) and Neuropsychological Assessment tests (duration approx. 1.5h). After completing the assessment, participants will be given the opportunity to do the exercise sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed, agility and dynamic balance
The following physical fitness and health parameters will be evaluated:
6-Minute Walk Test (Distance)
At the start signal, the subjects were instructed to walk as fast as possible (without running) for 6 minutes. During the test, the supervisor walked slightly behind the participant, avoiding accompanying them side by side so as not to influence the self-selected walking pace.
Measured: 3 months
Speed, agility and dynamic balance
Eight-Foot Up and Go Test (Seconds)
A chair was placed at the starting point with a cone positioned 8 feet (2.44 m) away. Participants, starting seated with hands on knees, stood up, walked quickly around the cone, and returned to the chair, with timing starting on "go" and stopping when they sat back down.
Measured: 3 months
Strength assessment
The following physical fitness and health parameters will be evaluated:
Seated Medicine Ball Throw (Meters)
The seated medicine ball throw test measured upper body strength and power. Participants were seated on a chair, with the trunk against the chair back, holding a 3 kg medicine ball in front of the trunk with both hands. Rotation of the trunk and hips was restricted during the test. Three throws were performed with one-minute rest intervals to prevent fatigue. The distance from the point of release to where the ball contacted the ground was measured using a metric tape. The mean distance of the throws was used for subsequent analysis.
Measured: 3 months
Strength assessment
The following physical fitness and health parameters will be evaluated:
Arm Curl Test (n. Rep)
In the arm curl test, participants sat on a chair and were asked to flex the elbow of the strongest arm as many times as possible in 30 seconds while holding a 3 kg dumbbell. Participants were instructed to maintain a normal breathing pattern and keep the elbow at the side of the body throughout the test. A single repetition consisted of complete elbow flexion from maximum extension.
Measured: 3 months
Strength assessment
The following physical fitness and health parameters will be evaluated:
Handgrip Strength Test (Kg)
Handgrip strength test, indicative of upper limb muscle function, was measured using an adjustable digital hand dynamometer (Saehan, Model DHD-1, South Korea). Participants were seated with hips, knees, and elbows flexed at 90º, gripping the dynamometer in a neutral forearm position. Three measurements of grip strength were taken for each hand, with a two-minute rest period between attempts. The average of these measurements was used for data analysis.
Measured: 3 months
Strength assessment
The following physical fitness and health parameters will be evaluated:
Sit-to-Stand Test (n. Rep)
The sit-stand test was employed to indirectly assess lower limb muscle strength and functionality. Participants used a chair with a 40 cm height and a straight backrest [29]. With arms folded across the chest and plantar support on the floor throughout, participants were instructed to stand up and sit down as many times as possible within 30 seconds. The outcome of this test was determined by counting the number of times the participant successfully completed the sit-stand cycle.
Measured: 3 months
Flexibility assessment
The following physical fitness and health parameters will be evaluated:
Chair Sit-and-Reach Test (Cm)
Starting in a seated position, the participant moves their body forwards until they are sitting on the edge of the chair seat. The fold between the top of the leg and the buttocks should be level with the edge of the seat. With one leg bent and the foot fully on the ground, the other leg (the preferred leg) is extended towards the thigh, with the heel on the ground and the foot bent (approx. 90º). The participant should be encouraged to exhale as they flex forwards, avoiding sudden, rapid and strong movements, never reaching the limit of pain.
With the leg extended (but not hyper-extended), the participant flexes slowly forwards as far as the hip joint (the spine should remain as straight as possible, with the head in the extension of the spine, therefore not flexed), sliding the hands (one over the other, with the fingertips overlapping) along the extended leg, trying to touch the t
Measured: 3 months
Flexibility assessment
The following physical fitness and health parameters will be evaluated:
Back Scratch Test (Cm)
In the standing position, the participant places their dominant hand on top of it and reaches as low as possible towards the middle of their back, palm down and fingers extended (elbow pointing upwards). The hand of the other arm is placed underneath and behind, palm facing upwards, trying to reach as far as possible in an attempt to touch (or overlap) the middle fingers of both hands.
Measured: 3 months
Cognitive assessment
The cognitive assessment protocol aims to evaluate multiple dimensions of cognition, including memory, concentration, attention, and executive cognitive functions, as well as their severity. The assessment will include the following validated tests:
Mini-Mental State Illiterate < 15
1 to 11 years of schooling < 22 With more than 11 years of schooling < 27
Measured: 3 months
Salivary assessment
Additionally, saliva samples will be analyzed for inflammatory markers such as IL-6 and IL-10, which have been reported in the literature as altered in individuals with dementia
The assessment of biomarkers was conducted at baseline, after 6 weeks, and post-intervention. To ensure the quality of the samples collected, the experimental collection protocol adhered to strict guidelines. Sampling was consistently performed at the same time (9-11 a.m.) to account for the circadian rhythm of hormones and salivary proteins. The "passive drool" method (unstimulated saliva) was used, where participants sat comfortably, rinsed their mouth with water to remove any residue, and waited 10 minutes before collection began. Saliva was accumulated under the tongue and collected in Falcon tubes. The samples were then transferred to cryotubes and stored at -80 °C.
Measured: 3 months
Salivary assessment
Additionally, saliva samples will be analyzed for inflammatory markers such as TNF-α, which have been reported in the literature as altered in individuals with dementia.
The assessment of biomarkers was conducted at baseline, after 6 weeks, and post-intervention. To ensure the quality of the samples collected, the experimental collection protocol adhered to strict guidelines. Sampling was consistently performed at the same time (9-11 a.m.) to account for the circadian rhythm of hormones and salivary proteins. The "passive drool" method (unstimulated saliva) was used, where participants sat comfortably, rinsed their mouth with water to remove any residue, and waited 10 minutes before collection began. Saliva was accumulated under the tongue and collected in Falcon tubes. The samples were then transferred to cryotubes and stored at -80 °C.
Measured: 3 months
Body Composition Assessment
Bodyweight (kilogram) BMI The percentage of fat mass was assessed using bioelectrical impedance analysis (BC-BC-613; TANITA, United Kingdom). Body mass index (BMI) was calculated as weight (kg) divided by height squared (m^2). Height measurements were taken using a stadiometer (Cabral, model 14). Participants removed their shoes and stood upright with feet flat on the floor, heels in contact, and their trunk and head positioned together against the stadiometer. The head position was neutral with the chin neither lifted nor tucked. Height measurements were recorded after participants exhaled.
Measured: 3 months
Body Composition Assessment
Free Fat mass (kilogram) Fat mass (%)
The percentage of fat mass and free fat mass was assessed using bioelectrical impedance analysis (BC-BC-613; TANITA, United Kingdom).
Measured: 3 months
Assessment of memory, concentration, attention and executive cognitive functions
Rey Auditory-Verbal Learning Test scores of ≤10 for more advanced dementia and ≤ 12 for mild/moderate
Measured: 3 months
Assessment of memory, concentration, attention and executive cognitive functions
Verbal Fluency Test (e.g., Units on a Scale) The Verbal Fluency Test is scored based on the total number of words or items generated by the individual.
Measured: 3 months
Quality of Life
Qality of Life PHQ-9 0 to 4: No depression. 5 to 9: Mild depression. 10 to 14: Moderate depression. 15 to 19: Moderately severe depression. 20 to 27: Severe depression.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start5 Nov 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Beira Interior
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Madeira, University of Beira Interior
- Investigators
- Dulce Esteves, PhD, Study director, University of Beira Interior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722976
- Sponsor's protocol ID
- CE-UBI-Pj-2023-064-ID1994
- Other IDs
- PRT/BD/154440/2022
- Acronym
- DigitalHEAL
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The sharing of individual participant data may be conducted upon request, ensuring that the identification of individuals is always protected to maintain the anonymity of those involved in the research. This approach guarantees the confidentiality and privacy of participants, in accordance with ethical and legal requirements related to data protection.
Publications
Hu JP, Guo YH, Wang F, Zhao XP, Zhang QH, Song QH. Exercise improves cognitive function in aging patients. Int J Clin Exp Med. 2014 Oct 15;7(10):3144-9. eCollection 2014.
PubMed 25419345Janson P, Willeke K, Zaibert L, Budnick A, Berghofer A, Kittel-Schneider S, Heuschmann PU, Zapf A, Wildner M, Stupp C, Keil T. Mortality, Morbidity and Health-Related Outcomes in Informal Caregivers Compared to Non-Caregivers: A Systematic Review. Int J Environ Res Public Health. 2022 May 11;19(10):5864. doi: 10.3390/ijerph19105864.
PubMed 35627399Tokovska M, Nour MM, Sorensen A, Smaland Goth U. Informal caregivers and psychosocial support: Analysis of European Dementia Policy documents. J Public Health Res. 2021 Sep 27;11(1):2416. doi: 10.4081/jphr.2021.2416.
PubMed 34579521
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital HEAL (Health and Exercise for Autonomous Longevity)
- ClinicalTrials.gov ID
- NCT06722976
- Acronym / sponsor ID
- DigitalHEAL / CE-UBI-Pj-2023-064-ID1994
- Conditions
- Mild Cognitive Impairment (MCI), Older People
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Beira InteriorUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 9 Dec 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.
Digital HEAL (Health and Exercise for Autonomous Longevity) is a multicomponent training program (combining concurrent training with cognitive stimulation) designed to promote physical fitness and cognitive function in older adults. This program merges a community-based approach with a scientific research project aimed at comparing the effects of in-person and online concurrent training on cognitive function and functional capacity in this population.
The program is structured into three phases: (1) Initial Assessment; (2) Multicomponent Training Sessions; (3) Final Assessment.
- Initial Assessment The initial assessment will consist of physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).
- Multicomponent Training Sessions The multicomponent training sessions will last for 3 months, with a frequency of two sessions per week, each lasting 50 minutes, conducted in person at the institution.
- Final Assessment The final assessment will be identical to the initial assessment, comprising physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).
Expected Benefits The anticipated benefits for participants include significant improvements in physical fitness, with a particular emphasis on strength, balance, and motor autonomy, which play an essential role in fall prevention. Additionally, cognitive abilities such as orientation, memory, and brain plasticity are expected to improve. The program also aims to promote social interaction, reducing social isolation among older adults. Furthermore, the program will support participants\' maintenance within the institution, which helps preserve their routine and address mobility and accessibility limitations. This intervention will also help reduce costs and time for the institution.
Potential Risks The risks associated with participation in the program are similar to those inherent in any physical activity. However, the equipment and environment (floor type, lighting, temperature) are evaluated to ensure suitability for safe exercise at any age. The exercises are supervised by a qualified professional who takes special care to minimize exercise-related risks.
Detailed description
Digital HEAL (Health and Exercise for Autonomous Longevity) is a multicomponent training program (combining concurrent training with cognitive stimulation) designed to promote physical fitness and cognitive function in older adults. This program merges a community-based approach with a scientific research project aimed at comparing the effects of in-person and online concurrent training on cognitive function and functional capacity in this population.
The program is developed and implemented by the Department of Sports Sciences, the Faculty of Health Sciences, and the Department of Psychology and Education of the University of Beira Interior (UBI), in collaboration with the University of Turin. The principal investigator is Ricardo André Alves Bispo Madeira.
The program is structured into three phases: (1) Initial Assessment; (2) Multicomponent Training Sessions; (3) Final Assessment.
- Initial Assessment The initial assessment will consist of physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).
- Multicomponent Training Sessions The multicomponent training sessions will last for 3 months, with a frequency of two sessions per week, each lasting 50 minutes, conducted in person at the institution.
- Final Assessment The final assessment will be identical to the initial assessment, comprising physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).
Expected Benefits The anticipated benefits for participants include significant improvements in physical fitness, with a particular emphasis on strength, balance, and motor autonomy, which play an essential role in fall prevention. Additionally, cognitive abilities such as orientation, memory, and brain plasticity are expected to improve. The program also aims to promote social interaction, reducing social isolation among older adults. Furthermore, the program will support participants\' maintenance within the institution, which helps preserve their routine and address mobility and accessibility limitations. This intervention will also help reduce costs and time for the institution.
Potential Risks The risks associated with participation in the program are similar to those inherent in any physical activity. However, the equipment and environment (floor type, lighting, temperature) are evaluated to ensure suitability for safe exercise at any age. The exercises are supervised by a qualified professional who takes special care to minimize exercise-related risks.
Voluntary Participation and Confidentiality Participation in the program is entirely voluntary, and participants can withdraw at any time without any consequences. Confidentiality is guaranteed, with only the principal investigator, Ricardo André Alves Bispo Madeira, having access to personal data, which will always be coded and not disclosed. The collected data will be used strictly for academic purposes, with no commercial interests. Upon request, individual data can be provided to each participant, improving the assessment of their current condition.
Research Team
The team of researchers involved includes:
Dr. Maria da Assunção Vaz Patto (Associate Professor at the Faculty of Health Sciences, UBI, and researcher at the Health Sciences Research Center - CICS-UBI) Dr. Maria Dulce Leal Esteves (Lecturer in the Department of Sports Sciences and researcher at the Research Center for Sport, Health, and Human Development - CIDESD) Dr. Nuno Filipe Cardoso Pinto (Adjunct Assistant Professor at the Faculty of Health Sciences, UBI, and researcher at CICS-UBI) Ricardo André Alves Bispo Madeira (Ph.D. student in Sports Sciences)
Principal Investigator Signature
By signing this document, I confirm, on behalf of the research team, that I have conveyed all the information contained herein, explained it, and answered all questions and concerns raised by the participant and their family members.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| face-to-face | Experimental | Other: Multicomponent exercise programsThe program is organized into three phases: (1) Initial assessment; (2) Multicomponent training sessions; (3) Final assessment. 1. The initial assessment will consist of physical fitness tests (lasting around 1 hour) and Neuropsychological Assessment tests (lasting around 1.5 hours). 2. The multicomponent training sessions will last 3 months, twice a week, 50 minutes each session, held in person at the institution. 3. The final assessment will be the same as the initial assessment (physical fitness tests (about 1 hour) and Neuropsychological Assessment tests (about 1.5 hours). |
| Synchronous distance (video call) | Experimental | Other: Multicomponent exercise programsThe program is organized into three phases: (1) Initial assessment; (2) Multicomponent training sessions; (3) Final assessment. 1. The initial assessment will consist of physical fitness tests (lasting around 1 hour) and Neuropsychological Assessment tests (lasting around 1.5 hours). 2. The multicomponent training sessions will last 3 months, twice a week, 50 minutes each, carried out by video call. 3. The final assessment will be the same as the initial assessment (physical fitness tests (about 1 hour) and Neuropsychological Assessment tests (about 1.5 hours). |
| Control group | No intervention | –In the control group, the participants take part in the training sessions, and the program is organized into two phases: (1) Initial assessment; (2) Final assessment. 1. The initial assessment will consist of physical fitness tests (lasting around 1 hour) and Neuropsychological Assessment tests (lasting around 1.5 hours). 2. The final assessment will be the same as the initial assessment (physical fitness tests (duration approx. 1h) and Neuropsychological Assessment tests (duration approx. 1.5h). After completing the assessment, participants will be given the opportunity to do the exercise sessions. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants aged ≥ 65 years.
- A score of ≥ 3 on the Short Physical Performance Battery (SPPB).
- Willingness to participate in the training programs and collaborate with the research team.
- Ability to provide informed consent, either oral or written.
Key exclusion criteria (6 listed)
- A score of ≤ 3 on the Short Physical Performance Battery (SPPB).
- Presence of severe comorbidities that would negatively impact participation in the training program.
- Presence of color blindness.
- Diagnosis of severe dementia or severe impairment across multiple dimensions of cognition, which would prevent participation in the training program.
- History of surgeries or fractures within the last 6 months.
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 exercise programsThe program is organized into three phases: (1) Initial assessment; (2) Multicomponent training sessions; (3) Final assessment. 1. The initial assessment will consist of physical fitness tests (lasting around 1 hour) and Neuropsychological Assessment tests (lasting around 1.5 hours). 2. The multicomponent training sessions will last 3 months, twice a week, 50 minutes each session. 3. The final assessment will be the same as the initial assessment (physical fitness tests (about 1 hour) and Neuropsychological Assessment tests (about 1.5 hours). | Other | Synchronous distance (video call), face-to-face |
Primary outcome
Speed, agility and dynamic balance
Time frame: 3 months
The following physical fitness and health parameters will be evaluated: 6-Minute Walk Test (Distance) At the start signal, the subjects were instructed to walk as fast as possible (without running) for 6 minutes. During the test, the supervisor walked slightly behind the participant, avoiding accompanying them side by side so as not to influence the self-selected walking pace.
Speed, agility and dynamic balance
Time frame: 3 months
Eight-Foot Up and Go Test (Seconds) A chair was placed at the starting point with a cone positioned 8 feet (2.44 m) away. Participants, starting seated with hands on knees, stood up, walked quickly around the cone, and returned to the chair, with timing starting on "go" and stopping when they sat back down.
Strength assessment
Time frame: 3 months
The following physical fitness and health parameters will be evaluated: Seated Medicine Ball Throw (Meters) The seated medicine ball throw test measured upper body strength and power. Participants were seated on a chair, with the trunk against the chair back, holding a 3 kg medicine ball in front of the trunk with both hands. Rotation of the trunk and hips was restricted during the test. Three throws were performed with one-minute rest intervals to prevent fatigue. The distance from the point of release to where the ball contacted the ground was measured using a metric tape. The mean distance of the throws was used for subsequent analysis.
Strength assessment
Time frame: 3 months
The following physical fitness and health parameters will be evaluated: Arm Curl Test (n. Rep) In the arm curl test, participants sat on a chair and were asked to flex the elbow of the strongest arm as many times as possible in 30 seconds while holding a 3 kg dumbbell. Participants were instructed to maintain a normal breathing pattern and keep the elbow at the side of the body throughout the test. A single repetition consisted of complete elbow flexion from maximum extension.
Strength assessment
Time frame: 3 months
The following physical fitness and health parameters will be evaluated: Handgrip Strength Test (Kg) Handgrip strength test, indicative of upper limb muscle function, was measured using an adjustable digital hand dynamometer (Saehan, Model DHD-1, South Korea). Participants were seated with hips, knees, and elbows flexed at 90º, gripping the dynamometer in a neutral forearm position. Three measurements of grip strength were taken for each hand, with a two-minute rest period between attempts. The average of these measurements was used for data analysis.
Strength assessment
Time frame: 3 months
The following physical fitness and health parameters will be evaluated: Sit-to-Stand Test (n. Rep) The sit-stand test was employed to indirectly assess lower limb muscle strength and functionality. Participants used a chair with a 40 cm height and a straight backrest [29]. With arms folded across the chest and plantar support on the floor throughout, participants were instructed to stand up and sit down as many times as possible within 30 seconds. The outcome of this test was determined by counting the number of times the participant successfully completed the sit-stand cycle.
Flexibility assessment
Time frame: 3 months
The following physical fitness and health parameters will be evaluated: Chair Sit-and-Reach Test (Cm) Starting in a seated position, the participant moves their body forwards until they are sitting on the edge of the chair seat. The fold between the top of the leg and the buttocks should be level with the edge of the seat. With one leg bent and the foot fully on the ground, the other leg (the preferred leg) is extended towards the thigh, with the heel on the ground and the foot bent (approx. 90º). The participant should be encouraged to exhale as they flex forwards, avoiding sudden, rapid and strong movements, never reaching the limit of pain. With the leg extended (but not hyper-extended), the participant flexes slowly forwards as far as the hip joint (the spine should remain as straight as possible, with the head in the extension of the spine, therefore not flexed), sliding the hands (one over the other, with the fingertips overlapping) along the extended leg, trying to touch the t
Flexibility assessment
Time frame: 3 months
The following physical fitness and health parameters will be evaluated: Back Scratch Test (Cm) In the standing position, the participant places their dominant hand on top of it and reaches as low as possible towards the middle of their back, palm down and fingers extended (elbow pointing upwards). The hand of the other arm is placed underneath and behind, palm facing upwards, trying to reach as far as possible in an attempt to touch (or overlap) the middle fingers of both hands.
Cognitive assessment
Time frame: 3 months
The cognitive assessment protocol aims to evaluate multiple dimensions of cognition, including memory, concentration, attention, and executive cognitive functions, as well as their severity. The assessment will include the following validated tests: Mini-Mental State Illiterate < 15 1 to 11 years of schooling < 22 With more than 11 years of schooling < 27
Salivary assessment
Time frame: 3 months
Additionally, saliva samples will be analyzed for inflammatory markers such as IL-6 and IL-10, which have been reported in the literature as altered in individuals with dementia The assessment of biomarkers was conducted at baseline, after 6 weeks, and post-intervention. To ensure the quality of the samples collected, the experimental collection protocol adhered to strict guidelines. Sampling was consistently performed at the same time (9-11 a.m.) to account for the circadian rhythm of hormones and salivary proteins. The "passive drool" method (unstimulated saliva) was used, where participants sat comfortably, rinsed their mouth with water to remove any residue, and waited 10 minutes before collection began. Saliva was accumulated under the tongue and collected in Falcon tubes. The samples were then transferred to cryotubes and stored at -80 °C.
Salivary assessment
Time frame: 3 months
Additionally, saliva samples will be analyzed for inflammatory markers such as TNF-α, which have been reported in the literature as altered in individuals with dementia. The assessment of biomarkers was conducted at baseline, after 6 weeks, and post-intervention. To ensure the quality of the samples collected, the experimental collection protocol adhered to strict guidelines. Sampling was consistently performed at the same time (9-11 a.m.) to account for the circadian rhythm of hormones and salivary proteins. The "passive drool" method (unstimulated saliva) was used, where participants sat comfortably, rinsed their mouth with water to remove any residue, and waited 10 minutes before collection began. Saliva was accumulated under the tongue and collected in Falcon tubes. The samples were then transferred to cryotubes and stored at -80 °C.
Body Composition Assessment
Time frame: 3 months
Bodyweight (kilogram) BMI The percentage of fat mass was assessed using bioelectrical impedance analysis (BC-BC-613; TANITA, United Kingdom). Body mass index (BMI) was calculated as weight (kg) divided by height squared (m^2). Height measurements were taken using a stadiometer (Cabral, model 14). Participants removed their shoes and stood upright with feet flat on the floor, heels in contact, and their trunk and head positioned together against the stadiometer. The head position was neutral with the chin neither lifted nor tucked. Height measurements were recorded after participants exhaled.
Body Composition Assessment
Time frame: 3 months
Free Fat mass (kilogram) Fat mass (%) The percentage of fat mass and free fat mass was assessed using bioelectrical impedance analysis (BC-BC-613; TANITA, United Kingdom).
Assessment of memory, concentration, attention and executive cognitive functions
Time frame: 3 months
Rey Auditory-Verbal Learning Test scores of ≤10 for more advanced dementia and ≤ 12 for mild/moderate
Assessment of memory, concentration, attention and executive cognitive functions
Time frame: 3 months
Verbal Fluency Test (e.g., Units on a Scale) The Verbal Fluency Test is scored based on the total number of words or items generated by the individual.
Quality of Life
Time frame: 3 months
Qality of Life PHQ-9 0 to 4: No depression. 5 to 9: Mild depression. 10 to 14: Moderate depression. 15 to 19: Moderately severe depression. 20 to 27: Severe depression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 25419345Hu JP, Guo YH, Wang F, Zhao XP, Zhang QH, Song QH. Exercise improves cognitive function in aging patients. Int J Clin Exp Med. 2014 Oct 15;7(10):3144-9. eCollection 2014.
- Background: PubMed 35627399Janson P, Willeke K, Zaibert L, Budnick A, Berghofer A, Kittel-Schneider S, Heuschmann PU, Zapf A, Wildner M, Stupp C, Keil T. Mortality, Morbidity and Health-Related Outcomes in Informal Caregivers Compared to Non-Caregivers: A Systematic Review. Int J Environ Res Public Health. 2022 May 11;19(10):5864. doi: 10.3390/ijerph19105864.
- Background: PubMed 34579521Tokovska M, Nour MM, Sorensen A, Smaland Goth U. Informal caregivers and psychosocial support: Analysis of European Dementia Policy documents. J Public Health Res. 2021 Sep 27;11(1):2416. doi: 10.4081/jphr.2021.2416.
- Individual participant dataSharing planned: Yes. The sharing of individual participant data may be conducted upon request, ensuring that the identification of individuals is always protected to maintain the anonymity of those involved in the research. This approach guarantees the confidentiality and privacy of participants, in accordance with ethical and legal requirements related to data protection.
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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.
Dulce Esteves, PhD study director
University of Beira Interior
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 exercise programs in people with Mild Cognitive Impairment (MCI) and Older People, run by University of Beira Interior 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 6 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: enrolling by invitation, as of the sponsor's last update on 12 Dec 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Speed, agility and dynamic balance (time frame: 3 months). The study lists 16 primary outcomes in all. 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 NCT06722976, which also lists 3 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 12 Dec 2024.