Digital Health and Exercise for Autonomous Longevity Program

Not Applicable

• Conditions: Mild Cognitive Impairment (MCI); Older People

• Registration Number: NCT06722976
• Lead Sponsor: University of Beira Interior

Brief 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. 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.

1. Initial Assessment The initial assessment will consist of physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).

2. 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.

3. 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.

1. Initial Assessment The initial assessment will consist of physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).

2. 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.

3. 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 Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-05
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-07
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-06-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body Composition Assessment	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	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.
Speed, agility and dynamic balance	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.
Cognitive assessment	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
Strength assessment	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.
Quality of Life	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.
Flexibility assessment	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.
Salivary assessment	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.

Trial Locations

Locations (1)

Departement of Sports Science; 🇵🇹 Covilhã, Portugal