Physical ActivityDance On 50+NCT07158866
DanceOn50+: Effects of a Dance Program on Physical and Psycho-emotional Health
A study testing Ballroom Dance and Multicomponent Exercise in people with Physical Activity and Physical Fitness, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Aging is associated with a decline in physical and cognitive function affecting autonomy and the ability to perform daily living activities. Interventions aiming the promotion of healthy aging and life-long learning are required to improve physical and cognitive health in a social context. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Physical Fitness, Well Being
- What is being tested?
- Ballroom Dance and Multicomponent Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Jul 2025to 31 Jan 2026
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 years or over;
- informed consent signed;
- not be institutionalized;
- not participating in any type of physical exercise program in the last 3 months.
Who cannot join
- absence of dementia;
- unstable cardiovascular disease or musculoskeletal dysfunction that makes participation in moderate-intensity exercises impossible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dance On 50+: Effects of a Dance Program on Physical and Psycho-emotional Health
Aging is associated with a decline in physical and cognitive function affecting autonomy and the ability to perform daily living activities. Interventions aiming the promotion of healthy aging and life-long learning are required to improve physical and cognitive health in a social context.
Dance is a cultural and physical activity that can be well adapted for older adults. Dance might counteract physical and cognitive functional decline and promotes social and emotional interactions. Importantly, dance can be individually adjusted in terms of physical fitness and cultural background. However, to date, there is a lack of research on the effects of a dance intervention with older adults setting to promote healthy aging and lifelong learning. Thus, this research project aims to explore the impact of a dance-based intervention with older adults from the community on physical, cognitive and psycho-emotional health while simultaneously generating inclusive artistic experiences and lifelong learning opportunities.
Read more
The study includes a quantitative quasi-experimental design. The study sample consists of healthy individuals from the community aged ≥ 50 years recruited through community programs and social media platforms. Those who agree to participate will be informed of the project objectives and procedures. Participation in the study is voluntary, and all participants will be required to sign a voluntary informed consent form.
Participants will be assigned to a dance training group, Multicomponent Exercise Group or the control group (no intervention). Outcomes will be measured using the Astrand Cycle Ergometer Submaximal Test, Open Circuit Pirometer Technique, Battery Senior Fitness Test, Isokinetic Dynamometer and Handgrip Dynamometer to assess physical fitness, Accelerometer, and Pittsburgh Sleep Quality Index to assess physical activity, sedentary behaviour, and sleep; psychoemotional questionnaires validated on Portuguese subjects to assess psychoemotional variables; tape measure and bioeletric impedance balance to assess body composition; digital sphygmomanometer and spirometry to assess cardiovascular and respiratory function; neurocognitive and psychological tests to assess cognitive function; and electroencephalography to assess electrophysiology.
Read the detailed description
The benefits of a dance intervention for Older Adults (OA) may go beyond those associated with PA. A dance program for OA showed improvements in strength, aerobic endurance, flexibility, motor agility/dynamic balance and suggested that PA that endorses cognitive stimulation is more effective in promoting psychological benefits. Dancing for OA based on choreographies, increased volumes in brain regions related to higher cognitive processes including, working memory and attention. Dancing stimulates a large number of physiological processes at the same time: spatial orientation, movement coordination, balance, endurance, interaction and communication, counteracting age-related declines in brain structure. An elegant review suggests the protective effect of a dance intervention on cognition in OA and states that the possibility of adapting intensity and style to suit possible physical limitations makes this activity very suitable for OA. There are also suggestions that, even in older intermediate-level dancer, the practice of social dance might positively influence body composition and also increase fitness performance, memory and anxiety.
Dance requires the synergy of physical and cognitive faculties, using the body to communicate and create an aesthetic form of artistic expression, promoting social and emotional interactions. Dancing improves mental wellbeing and fitness, promoting a sense of community, intimacy, enjoyment and self-fulfillment. Krekula's interviews with OA show that age can be challenged through dance, with the ageing body viewed as a 'source of passion', rather than problematic and people feeling younger, which correlates with higher subjective wellbeing.
Although dance can promote health-related benefits in OA, it is recognized that the few studies in the field seem very heterogonous regarding the trial designs, characteristics of the interventions, outcomes assessments, and methodological quality. Additionally, there are a lack of studies reporting the effects of different styles (i. e. creative, ballroom, traditional dances and others) and its intensity on physical function, particularly in OA. From our knowledge, there are limited studies, on OA, characterizing:
- the intensity of ballroom dance sessions;
- physical and cardiorespiratory adaptative responses induced by a ballroom dance program;
- cognitive and psycho-emotional benefits induced by a ballroom dance program. Therefore, in order to recommend dance as a health promoter intervention for OA, it is urgent to evaluate health-related outcomes of a structured dancing community program.
The present project is a community-based intervention. The majority of existing studies on dance focus on specific populations that have been screened for certain conditions, whereas we will encompass a general population of older adults. To our knowledge, there is a lack of information regarding dance sessions characterization, as well as the health outcomes that a group dance intervention can possibly modulate, including cognitive, physical function and psycho-emotional variables. Therefore, the two main research questions behind this project are:
- What physical exercise intensity can be achieved during dance sessions for older adults?
- Can a dance-based intervention positively impact physical, cognitive and psycho-emotional health-related outcomes? To address these questions, the present project aims to characterize dance sessions and explore the impacts of a group dance intervention for older adults within the community, with a focus on simultaneously promoting physical, functional, and cognitive capacities. To provide a comprehensive analysis, comparisons will be made with a control group and a multicomponent exercise group, which is one of the most extensively studied exercise interventions for older adults The research will adopt a quantitative quasi-experimental design and will take place in the metropolitan region of Porto, Portugal. The participant pool will include healthy individuals aged 50 and above, recruited through community programs, local municipalities, health centers, and social media platforms via phone calls and informational brochures. Those who consent to participate will be thoroughly informed about the aims and methods of the study. Participation will be voluntary, and all participants will be asked to sign an informed consent form before taking part in the study.
Participants will be randomly assigned to one of three groups:
- Dance On group (dance intervention).
- Multicomponent Exercise group (multicomponent physical training).
- Control group (no engagement in planned physical activities). Screening will be carried out using a comprehensive questionnaire, collecting socio-demographic and health-related information to ensure that participants meet the inclusion and exclusion criteria for each group.
- Conditions
- Physical Activity, Physical Fitness, Well Being
- Being tested
- Ballroom Dance, Multicomponent Exercise
- Keywords
- Active aging, Physical fitness, Cognitive health, Psycho-emotional health
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ballroom DanceBehavioural
The intervention will involve twice-weekly dance sessions, lasting 45 minutes each, for 6 months. Each session will include:
- Rhythmic warm-up with music.
- Combination of aerobic, resistance, and coordination exercises.
- Technical development and learning of dance routines.
- Cool down with free-body movements to slow music.
Multicomponent ExerciseBehavioural
The Multicomponent Exercise intervention will target several physical fitness components simultaneously, including strength, balance, and aerobic fitness. The program will consist of twice-weekly sessions, each lasting 45 minutes, for 6 months. Each session will include:
- Warm-up with light stretching and joint mobility exercises.
- Balance exercises
- Strength training exercises
- Aerobic exercises
- Cool down with flexibility and relaxation exercises.
| Study group | Role | What they receive |
|---|---|---|
| Ballroom dance Group | Experimental | Not described Receives: Behavioral: Ballroom Dance |
| Multicomponent Exercise Group | Experimental | Not described Receives: Behavioral: Multicomponent Exercise |
| control group | No intervention | Participants from the control group will participate in all assesments moments and will be asked to maintain their usual activities. At the end of intervention period, the contol group will be invited to participate in a physical activity program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological testing (Depression) - GDS
The Geriatric Depression Scale (GDS, short version) will be used to assess depressive symptoms. The Geriatric Depression Scale (GDS), short version, is a self-report instrument developed specifically to screen for depressive symptoms in older adults. The short version consists of 15 yes/no questions, selected from the original 30-item version, and is designed to minimize the influence of somatic symptoms that may overlap with physical ageing processes. Its simplicity and clarity make it especially suitable for older populations, including those with mild cognitive impairments.
This tool has been widely validated across various settings and cultures, demonstrating good sensitivity and specificity for detecting clinically relevant depressive symptoms in the elderly. Scores range from 0 to 15, with higher scores indicating greater depressive symptomatology. Cut-off points commonly used are: 0-4 (normal), 5-8 (mild depression), 9-11 (moderate depression), and 12-15 (severe depression).
In
Measured: Baseline, 6 months
Psychological testing (Anxiety) - EADS-21
Anxiety symptoms will be assessed using the Hamilton Anxiety Rating Scale (HARS), also known as Escala de Ansiedade de Hamilton (EADS) in its Portuguese version. The HARS is a clinician-administered scale that evaluates the severity of anxiety symptoms across psychological and physical domains. It is widely recognized for its high reliability and validity, and is used in both clinical and research settings.
The scale consists of 14 items that assess various aspects of anxiety, such as tension, fears, insomnia, cognitive impairment, somatic complaints, and autonomic symptoms. Each item is rated on a 5-point Likert scale, ranging from 0 (absent) to 4 (severe).
The total score can range from 0 to 56, with higher scores indicating more severe levels of anxiety. The commonly used classification is as follows:
0-17: Mild anxiety 18-24: Moderate anxiety 25-56: Severe anxiety
Measured: Baseline, 6 months
Peak oxygen uptake (VO2 peak)
The Astrand Cycle Ergometer - This sub-maximal test with incremental protocol and performed on a ergometer, standard an open-circuit spirometer technique (Cosmed K5b2, Cosmed, Rome, Italy) will be used.
Measured: Baseline, 6 months
Lower-body strength and power
The knee extensors and flexors will be evaluated using an isokinetic dynamometer at two different angular velocities: 60°/s and 180°/s.
Measured: Baseline, 6 months
Physical-Functional Fitness (strength of the lower and upper body)
Physical-functional fitness is going to be measured via the Senior Fitness Test (SFT). This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), agility/dynamic balance (8-foot up-and-go test), aerobic endurance (six-minute walk test) and lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively). The chair stand test to assess the strength of the lower body, counting the number of repetitions made in 30s. And the arm curl test to assess the strength on the upper body, using a 3lb (women) and 5lb (men) dumbbell, counting the number of repetitions made in 30s.
Measured: Baseline, 3 months, 6 months
Physical-Functional Fitness (agility/dynamic balance)
Physical-functional fitness is going to be measured via the Senior Fitness Test (SFT). This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), agility/dynamic balance (8-foot up-and-go test), aerobic endurance (six-minute walk test) and lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively). The stand up, walk 8-foot distance (2,44 meters), turn the cone marker around and return to the seated position. The time, in seconds, necessary to complete this test will be registered.
Measured: Baseline, 3 months, 6 months
Physical-Functional Fitness (aerobic endurance)
Physical-functional fitness is going to be measured via the Senior Fitness Test (SFT). This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), agility/dynamic balance (8-foot up-and-go test), aerobic endurance (six-minute walk test) and lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively). The stand up, walk 8-foot distance (2,44 meters), turn the cone marker around and return to the seated position. The time, in seconds, necessary to complete this test will be registered.
Measured: Baseline, 3 months, 6 months
Physical-Functional Fitness (flexibility of the lower and upper-body)
Physical-functional fitness is going to be measured via the Senior Fitness Test (SFT). This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), agility/dynamic balance (8-foot up-and-go test), aerobic endurance (six-minute walk test) and lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively). The chair sit-\&-reach test to assess the flexibility of the lower-body, measured in cm. And The back scratch test to assess flexibility on the upper-body, measured in cm.
Measured: Baseline, 3 months, 6 months
Handgrip strength
The handgrip strength will be measured with a Jamar Plus + Digital hand dynamometer (Sammons Preston Inc., Bolingbrook, Illinois, USA). Measurements will be carried out following the American Society of Hand Therapists recommendations, and each participant will perform three attempts with a pause of 1 min between them. Three attempts will be made for each hand, using the maximum value of the three registers.
Measured: Baseline, 3 months, 6 months
Sociodemographic Assessments
Age (years), academic level (primary, secondary, bachelor, master, PhD), civil status (married, separated, widow, single, others), number of medications, diagnosed diseases.
Measured: Baseline
Body mass
Body mass (kg) will be analyzed with bioimpedance balance.
Measured: Baseline, 6 months
World Health Organization Quality of Life - WHOQOL - BREF
To assess participants perceived quality of life, the World Health Organization Quality of Life questionnaire (WHOQOL-BREF) will be used. This validated instrument consists of 26 items that measure four key domains: Physical Health, Psychological Health, Social Relationships, and Environment. Each item is rated on a 5-point Likert scale, and scores for each domain are calculated by summing specific items, then transforming the raw scores into a scale from 0 to 100, where higher scores indicate better perceived quality of life.
Measured: Baseline, 6 months
Life Satisfaction - SWLS
To assess overall life satisfaction, the Satisfaction with Life Scale (SWLS) will be administered. This instrument includes 5 items that reflect a global evaluation of an individual's life according to their own criteria and values. In this study, responses will be rated on a 6-point Likert scale ranging from 0 ("Strongly disagree") to 5 ("Strongly agree"), resulting in a total score ranging from 0 to 25. Higher scores indicate greater satisfaction with life. Interpretation of total scores typically follows these cut-offs: 0-4 (Extremely dissatisfied), 5-9 (Dissatisfied), 10-14 (Slightly dissatisfied), 15 (Neutral), 16-19 (Slightly satisfied), 20-22 (Satisfied), and 23-25 (Extremely satisfied).
Measured: Baseline, 6 months
Loneliness - UCLA-16
To assess perceived social isolation, this study will use the Portuguese-adapted version of the UCLA Loneliness Scale comprising 16 items. This version was culturally and linguistically validated for the Portuguese population, particularly in older adults, ensuring conceptual equivalence while excluding or modifying items less relevant in this context. Each item is rated on a 4-point Likert scale ranging from 1 ("Never") to 4 ("Often"). Total scores range from 16 to 64, with higher scores indicating greater perceived loneliness. The scale assesses key dimensions of loneliness, including feelings of social disconnectedness, lack of companionship, and emotional isolation.
Measured: Baseline, 6 months
Positive and Negative Affect - PANAS
To evaluate affective states, the study will use the Positive and Negative Affect Schedule (PANAS), a validated self-report instrument measuring two distinct dimensions of mood: Positive Affect (PA) and Negative Affect (NA). The PANAS consists of 20 items, with 10 items assessing PA-enthusiastic, interested, alert, inspired, determined, attentive, active, proud, excited, and strong-and 10 items assessing NA-distressed, upset, guilty, scared, hostile, irritable, ashamed, nervous, jittery, and afraid. Participants rate how much they have experienced each emotion over a specified time frame on a 5-point Likert scale ranging from 1 ("Very slightly or not at all") to 5 ("Extremely"). Scores for each subscale are summed separately, with possible ranges of 10 to 50. Higher PA scores indicate greater positive emotional engagement, while higher NA scores reflect higher levels of distress and negative emotional experience.
Measured: Baseline, 6 months
Physical Activity
Physical Activity will be tested by Accelerometer-based activity monitors GT3X+ Link (ActiGraph)
Measured: Baseline, 6 months
Sleep Quality - PSQI-PT
To assess sleep quality, the study will use the Pittsburgh Sleep Quality Index - Portuguese version (PSQI-PT), a widely validated self-report questionnaire designed to measure sleep quality and disturbances over a one-month period. The PSQI-PT consists of 19 items, which generate seven component scores assessing different dimensions of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, and the sum of these yields a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality, with a commonly used cut-off of >5 to distinguish poor sleepers from good sleepers.
Measured: Baseline, 6 months
fat-free mass
fat-free mass (kg), will be analyzed with bioimpedence balance.
Measured: baseline, months
fat mass
fat mass (%) will be analyzed with bioimpedance balance.
Measured: baseline, 6 months
BMI - Body Mass Index
BMI (Kg/m^2) will be analyzed with bioimpedance balance.
Measured: baseline, 6 months
Secondary outcomes (9)
Cognitive performance (Memory)
Consortium to establish a registry for the Alzheimer's Disease List Test (CERAD), will be used: word list memory; word list recall; and word list recognition. The parameters: total hits and delayed recall hits.
Measured: Baseline, 6 months
Cognitive performance (Selective recall test)
Selective recall test [SRT-List A; parameters: consistent long-term recall, long-term storage, delayed recall, and intrusions] to assess verbal learning and multiple-trial memory.
Measured: Baseline, 6 months
Cognitive performance (Verbal short-term memory)
The Forward Digit Span (DS) test will be used to assess verbal short-term memory. This test is a subtest of the Wechsler Adult Intelligence Scale (WAIS-III).
The Forward DS test requires participants to repeat a sequence of digits in the same order they were presented, assessing their ability to hold and recall information over a short period.
The DS score is determined by the maximum number of digits the participant is able to accurately repeat in the correct order. A performance of 5 to 7 digits falls within the normative range. Scores below this range may indicate potential deficits in attention or short-term memory capacity, while scores above may reflect superior cognitive functioning.
Measured: Baseline, 6 months
Cognitive performance (Inhibition/cognitive flexibility)
The Stroop Color and Word Test (parameters: words, colors, and words/colors) will be selected to assess response inhibition/cognitive flexibility.
Measured: Baseline, 6 months
Cognitive performance (Processing speed)
Digit Symbol Substitution Test (DSST, subtest of the Wechsler test of adult intelligence WAIS III) will be used as a measure of high-level information processing speed.
Measured: Baseline, 6 months
Brain Activity
This will be analyzed using an electromyography (EEG) system. All EEG signals will be acquired with the ActiCHamp®, Brain Products,GmbH. With an international 10-20 system with standard 32-channel electrode layout with reference and ground electrodes. The ground will be located on the forehead and the reference will be the Cz channel of the ActiCHamp® equipment. For each participant, the same equipment will be used in all sessions.
Measured: Baseline, 6 months
Risk of Falls - FRAX
Risk of falls will be evaluated through The Fracture Assessment Risk Tool (FRAX).
Measured: Baseline, 6 months
Perceptions of the experience of participants
Qualitative analysis will be testd with Semi-structured interviews.
Measured: 6 months
Cognitive Performance (Verbal Working Memory)
Working memory will be assessed using the Backward Digit Span subtest from the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III). In this task, participants are required to repeat a sequence of digits in the reverse order of their presentation, evaluating their ability to mentally manipulate and retain verbal information. The Backward DS score is defined as the highest number of digits the participant can accurately reproduce in the correct reverse sequence. Performance typically ranges from 3 to 5 digits, based on normative data. Scores below this range may indicate difficulties in working memory or executive functioning, whereas scores above may suggest enhanced cognitive flexibility and working memory capacity.
Time Frame: Baseline, 6 months
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start15 Jul 2025
- Primary completion1 Aug 2025
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Physical Activity Intervention (Dance Classes and Multicomponent exercises)
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Magalhães, PhD, Study director, Faculty of Sport, University of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158866
- Sponsor's protocol ID
- CEFADE 31_2023
- Acronym
- Dance On 50+
- Status last verified
- Jul 2025
- First submitted
- 11 Feb 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be produced and stored in accordance with the data protection laws and the University of Porto internal regulations. Data collected by questionnaire and direct observation will be anonymized before storage. The sub-investigator will be the only person with access to the grid that contains the data coding. Data will be stored in the official University of Porto cloud and with a copy on a hard disk that will be in the sub-investigator possession.
Publications
Rodrigues-Krause J, Krause M, Reischak-Oliveira A. Dancing for Healthy Aging: Functional and Metabolic Perspectives. Altern Ther Health Med. 2019 Jan;25(1):44-63.
PubMed 29428927Vaccaro MG, Izzo G, Ilacqua A, Migliaccio S, Baldari C, Guidetti L, Lenzi A, Quattrone A, Aversa A, Emerenziani GP. Characterization of the Effects of a Six-Month Dancing as Approach for Successful Aging. Int J Endocrinol. 2019 Jun 17;2019:2048391. doi: 10.1155/2019/2048391. eCollection 2019.
PubMed 3131656219- Physical Activity Guidelines Advisory Committee, 2018. Physical Activity Guidelines Advisory Committee Scientific Report. Washington, DC: U.S. Department of Health and Human Services
Rehfeld K, Luders A, Hokelmann A, Lessmann V, Kaufmann J, Brigadski T, Muller P, Muller NG. Dance training is superior to repetitive physical exercise in inducing brain plasticity in the elderly. PLoS One. 2018 Jul 11;13(7):e0196636. doi: 10.1371/journal.pone.0196636. eCollection 2018.
PubMed 29995884Wilde NJ, Strauss E, Chelune GJ, Hermann BP, Hunter M, Loring DW, Martin RC, Sherman EM. Confirmatory factor analysis of the WMS-III in patients with temporal lobe epilepsy. Psychol Assess. 2003 Mar;15(1):56-63. doi: 10.1037/1040-3590.15.1.56.
PubMed 12674724Buschke H, Sliwinski M, Kuslansky G, Lipton RB. Aging, encoding specificity, and memory change in the Double Memory Test. J Int Neuropsychol Soc. 1995 Sep;1(5):483-93. doi: 10.1017/s1355617700000576.
PubMed 9375233Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. doi: 10.1212/wnl.39.9.1159.
PubMed 2771064Del Rio Joao KA, Becker NB, de Neves Jesus S, Isabel Santos Martins R. Validation of the Portuguese version of the Pittsburgh Sleep Quality Index (PSQI-PT). Psychiatry Res. 2017 Jan;247:225-229. doi: 10.1016/j.psychres.2016.11.042. Epub 2016 Nov 28.
PubMed 27923147Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 339786510- Pocinho, M., Farate, C. & Dias, C., (2010). Validação Psicométrica da Escala UCLA-Lonliness para Idosos Portugueses. Interções. 65-77.
Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
PubMed 163674938- World Health Organization. (2021). Obesity and Overweight. Retrieved July 2023 from https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight
6-Nagata, C. d. A., Hamu, T. C. D. d. S., Neri, S. G. R., Lima, R. M., & Garcia, P. A. (2023). Association between isokinetic strength measures and functional performance in community-dwelling older adults. Fisioterapia e Pesquisa, 30, e22014323en
5- Krekula, C., Pleasure and time in senior dance: bringing temporality into focus in the field of ageing. Ageing and Society, 2020: p. 1-16.
Cruz-Ferreira A, Marmeleira J, Formigo A, Gomes D, Fernandes J. Creative Dance Improves Physical Fitness and Life Satisfaction in Older Women. Res Aging. 2015 Nov;37(8):837-55. doi: 10.1177/0164027514568103. Epub 2015 Jan 29.
PubMed 25651595
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dance On 50+: Effects of a Dance Program on Physical and Psycho-emotional Health
- ClinicalTrials.gov ID
- NCT07158866
- Acronym / sponsor ID
- Dance On 50+ / CEFADE 31_2023
- Conditions
- Physical Activity, Physical Fitness, Well Being
- Keywords
- Active aging, Physical fitness, Cognitive health, Psycho-emotional health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 8 Sep 2025 (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.
Aging is associated with a decline in physical and cognitive function affecting autonomy and the ability to perform daily living activities. Interventions aiming the promotion of healthy aging and life-long learning are required to improve physical and cognitive health in a social context.
Dance is a cultural and physical activity that can be well adapted for older adults. Dance might counteract physical and cognitive functional decline and promotes social and emotional interactions. Importantly, dance can be individually adjusted in terms of physical fitness and cultural background. However, to date, there is a lack of research on the effects of a dance intervention with older adults setting to promote healthy aging and lifelong learning. Thus, this research project aims to explore the impact of a dance-based intervention with older adults from the community on physical, cognitive and psycho-emotional health while simultaneously generating inclusive artistic experiences and lifelong learning opportunities.
The study includes a quantitative quasi-experimental design. The study sample consists of healthy individuals from the community aged ≥ 50 years recruited through community programs and social media platforms. Those who agree to participate will be informed of the project objectives and procedures. Participation in the study is voluntary, and all participants will be required to sign a voluntary informed consent form.
Participants will be assigned to a dance training group, Multicomponent Exercise Group or the control group (no intervention). Outcomes will be measured using the Astrand Cycle Ergometer Submaximal Test, Open Circuit Pirometer Technique, Battery Senior Fitness Test, Isokinetic Dynamometer and Handgrip Dynamometer to assess physical fitness, Accelerometer, and Pittsburgh Sleep Quality Index to assess physical activity, sedentary behaviour, and sleep; psychoemotional questionnaires validated on Portuguese subjects to assess psychoemotional variables; tape measure and bioeletric impedance balance to assess body composition; digital sphygmomanometer and spirometry to assess cardiovascular and respiratory function; neurocognitive and psychological tests to assess cognitive function; and electroencephalography to assess electrophysiology.
Detailed description
The benefits of a dance intervention for Older Adults (OA) may go beyond those associated with PA. A dance program for OA showed improvements in strength, aerobic endurance, flexibility, motor agility/dynamic balance and suggested that PA that endorses cognitive stimulation is more effective in promoting psychological benefits. Dancing for OA based on choreographies, increased volumes in brain regions related to higher cognitive processes including, working memory and attention. Dancing stimulates a large number of physiological processes at the same time: spatial orientation, movement coordination, balance, endurance, interaction and communication, counteracting age-related declines in brain structure. An elegant review suggests the protective effect of a dance intervention on cognition in OA and states that the possibility of adapting intensity and style to suit possible physical limitations makes this activity very suitable for OA. There are also suggestions that, even in older intermediate-level dancer, the practice of social dance might positively influence body composition and also increase fitness performance, memory and anxiety.
Dance requires the synergy of physical and cognitive faculties, using the body to communicate and create an aesthetic form of artistic expression, promoting social and emotional interactions. Dancing improves mental wellbeing and fitness, promoting a sense of community, intimacy, enjoyment and self-fulfillment. Krekula's interviews with OA show that age can be challenged through dance, with the ageing body viewed as a 'source of passion', rather than problematic and people feeling younger, which correlates with higher subjective wellbeing.
Although dance can promote health-related benefits in OA, it is recognized that the few studies in the field seem very heterogonous regarding the trial designs, characteristics of the interventions, outcomes assessments, and methodological quality. Additionally, there are a lack of studies reporting the effects of different styles (i. e. creative, ballroom, traditional dances and others) and its intensity on physical function, particularly in OA. From our knowledge, there are limited studies, on OA, characterizing:
- the intensity of ballroom dance sessions;
- physical and cardiorespiratory adaptative responses induced by a ballroom dance program;
- cognitive and psycho-emotional benefits induced by a ballroom dance program. Therefore, in order to recommend dance as a health promoter intervention for OA, it is urgent to evaluate health-related outcomes of a structured dancing community program.
The present project is a community-based intervention. The majority of existing studies on dance focus on specific populations that have been screened for certain conditions, whereas we will encompass a general population of older adults. To our knowledge, there is a lack of information regarding dance sessions characterization, as well as the health outcomes that a group dance intervention can possibly modulate, including cognitive, physical function and psycho-emotional variables. Therefore, the two main research questions behind this project are:
- What physical exercise intensity can be achieved during dance sessions for older adults?
- Can a dance-based intervention positively impact physical, cognitive and psycho-emotional health-related outcomes? To address these questions, the present project aims to characterize dance sessions and explore the impacts of a group dance intervention for older adults within the community, with a focus on simultaneously promoting physical, functional, and cognitive capacities. To provide a comprehensive analysis, comparisons will be made with a control group and a multicomponent exercise group, which is one of the most extensively studied exercise interventions for older adults The research will adopt a quantitative quasi-experimental design and will take place in the metropolitan region of Porto, Portugal. The participant pool will include healthy individuals aged 50 and above, recruited through community programs, local municipalities, health centers, and social media platforms via phone calls and informational brochures. Those who consent to participate will be thoroughly informed about the aims and methods of the study. Participation will be voluntary, and all participants will be asked to sign an informed consent form before taking part in the study.
Participants will be randomly assigned to one of three groups:
- Dance On group (dance intervention).
- Multicomponent Exercise group (multicomponent physical training).
- Control group (no engagement in planned physical activities). Screening will be carried out using a comprehensive questionnaire, collecting socio-demographic and health-related information to ensure that participants meet the inclusion and exclusion criteria for each group.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Physical Activity Intervention (Dance Classes and Multicomponent exercises)
| Arm | Type | Receives |
|---|---|---|
| Ballroom dance Group | Experimental | Behavioral: Ballroom Dance |
| Multicomponent Exercise Group | Experimental | Behavioral: Multicomponent Exercise |
| control group | No intervention | –Participants from the control group will participate in all assesments moments and will be asked to maintain their usual activities. At the end of intervention period, the contol group will be invited to participate in a physical activity program. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50 years or over;
- informed consent signed;
- not be institutionalized;
- not participating in any type of physical exercise program in the last 3 months.
Key exclusion criteria (2 listed)
- absence of dementia;
- unstable cardiovascular disease or musculoskeletal dysfunction that makes participation in moderate-intensity exercises impossible
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 |
|---|---|---|
| Ballroom DanceThe intervention will involve twice-weekly dance sessions, lasting 45 minutes each, for 6 months. Each session will include: 1. Rhythmic warm-up with music. 2. Combination of aerobic, resistance, and coordination exercises. 3. Technical development and learning of dance routines. 4. Cool down with free-body movements to slow music. | Behavioural | Ballroom dance Group |
| Multicomponent ExerciseThe Multicomponent Exercise intervention will target several physical fitness components simultaneously, including strength, balance, and aerobic fitness. The program will consist of twice-weekly sessions, each lasting 45 minutes, for 6 months. Each session will include: 1. Warm-up with light stretching and joint mobility exercises. 2. Balance exercises 3. Strength training exercises 4. Aerobic exercises 5. Cool down with flexibility and relaxation exercises. | Behavioural | Multicomponent Exercise Group |
Primary outcome
Psychological testing (Depression) - GDS
Time frame: Baseline, 6 months
The Geriatric Depression Scale (GDS, short version) will be used to assess depressive symptoms. The Geriatric Depression Scale (GDS), short version, is a self-report instrument developed specifically to screen for depressive symptoms in older adults. The short version consists of 15 yes/no questions, selected from the original 30-item version, and is designed to minimize the influence of somatic symptoms that may overlap with physical ageing processes. Its simplicity and clarity make it especially suitable for older populations, including those with mild cognitive impairments. This tool has been widely validated across various settings and cultures, demonstrating good sensitivity and specificity for detecting clinically relevant depressive symptoms in the elderly. Scores range from 0 to 15, with higher scores indicating greater depressive symptomatology. Cut-off points commonly used are: 0-4 (normal), 5-8 (mild depression), 9-11 (moderate depression), and 12-15 (severe depression). In
Psychological testing (Anxiety) - EADS-21
Time frame: Baseline, 6 months
Anxiety symptoms will be assessed using the Hamilton Anxiety Rating Scale (HARS), also known as Escala de Ansiedade de Hamilton (EADS) in its Portuguese version. The HARS is a clinician-administered scale that evaluates the severity of anxiety symptoms across psychological and physical domains. It is widely recognized for its high reliability and validity, and is used in both clinical and research settings. The scale consists of 14 items that assess various aspects of anxiety, such as tension, fears, insomnia, cognitive impairment, somatic complaints, and autonomic symptoms. Each item is rated on a 5-point Likert scale, ranging from 0 (absent) to 4 (severe). The total score can range from 0 to 56, with higher scores indicating more severe levels of anxiety. The commonly used classification is as follows: 0-17: Mild anxiety 18-24: Moderate anxiety 25-56: Severe anxiety
Peak oxygen uptake (VO2 peak)
Time frame: Baseline, 6 months
The Astrand Cycle Ergometer - This sub-maximal test with incremental protocol and performed on a ergometer, standard an open-circuit spirometer technique (Cosmed K5b2, Cosmed, Rome, Italy) will be used.
Lower-body strength and power
Time frame: Baseline, 6 months
The knee extensors and flexors will be evaluated using an isokinetic dynamometer at two different angular velocities: 60°/s and 180°/s.
Physical-Functional Fitness (strength of the lower and upper body)
Time frame: Baseline, 3 months, 6 months
Physical-functional fitness is going to be measured via the Senior Fitness Test (SFT). This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), agility/dynamic balance (8-foot up-and-go test), aerobic endurance (six-minute walk test) and lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively). The chair stand test to assess the strength of the lower body, counting the number of repetitions made in 30s. And the arm curl test to assess the strength on the upper body, using a 3lb (women) and 5lb (men) dumbbell, counting the number of repetitions made in 30s.
Physical-Functional Fitness (agility/dynamic balance)
Time frame: Baseline, 3 months, 6 months
Physical-functional fitness is going to be measured via the Senior Fitness Test (SFT). This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), agility/dynamic balance (8-foot up-and-go test), aerobic endurance (six-minute walk test) and lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively). The stand up, walk 8-foot distance (2,44 meters), turn the cone marker around and return to the seated position. The time, in seconds, necessary to complete this test will be registered.
Physical-Functional Fitness (aerobic endurance)
Time frame: Baseline, 3 months, 6 months
Physical-functional fitness is going to be measured via the Senior Fitness Test (SFT). This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), agility/dynamic balance (8-foot up-and-go test), aerobic endurance (six-minute walk test) and lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively). The stand up, walk 8-foot distance (2,44 meters), turn the cone marker around and return to the seated position. The time, in seconds, necessary to complete this test will be registered.
Physical-Functional Fitness (flexibility of the lower and upper-body)
Time frame: Baseline, 3 months, 6 months
Physical-functional fitness is going to be measured via the Senior Fitness Test (SFT). This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), agility/dynamic balance (8-foot up-and-go test), aerobic endurance (six-minute walk test) and lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively). The chair sit-\&-reach test to assess the flexibility of the lower-body, measured in cm. And The back scratch test to assess flexibility on the upper-body, measured in cm.
Handgrip strength
Time frame: Baseline, 3 months, 6 months
The handgrip strength will be measured with a Jamar Plus + Digital hand dynamometer (Sammons Preston Inc., Bolingbrook, Illinois, USA). Measurements will be carried out following the American Society of Hand Therapists recommendations, and each participant will perform three attempts with a pause of 1 min between them. Three attempts will be made for each hand, using the maximum value of the three registers.
Sociodemographic Assessments
Time frame: Baseline
Age (years), academic level (primary, secondary, bachelor, master, PhD), civil status (married, separated, widow, single, others), number of medications, diagnosed diseases.
Body mass
Time frame: Baseline, 6 months
Body mass (kg) will be analyzed with bioimpedance balance.
World Health Organization Quality of Life - WHOQOL - BREF
Time frame: Baseline, 6 months
To assess participants perceived quality of life, the World Health Organization Quality of Life questionnaire (WHOQOL-BREF) will be used. This validated instrument consists of 26 items that measure four key domains: Physical Health, Psychological Health, Social Relationships, and Environment. Each item is rated on a 5-point Likert scale, and scores for each domain are calculated by summing specific items, then transforming the raw scores into a scale from 0 to 100, where higher scores indicate better perceived quality of life.
Life Satisfaction - SWLS
Time frame: Baseline, 6 months
To assess overall life satisfaction, the Satisfaction with Life Scale (SWLS) will be administered. This instrument includes 5 items that reflect a global evaluation of an individual's life according to their own criteria and values. In this study, responses will be rated on a 6-point Likert scale ranging from 0 ("Strongly disagree") to 5 ("Strongly agree"), resulting in a total score ranging from 0 to 25. Higher scores indicate greater satisfaction with life. Interpretation of total scores typically follows these cut-offs: 0-4 (Extremely dissatisfied), 5-9 (Dissatisfied), 10-14 (Slightly dissatisfied), 15 (Neutral), 16-19 (Slightly satisfied), 20-22 (Satisfied), and 23-25 (Extremely satisfied).
Loneliness - UCLA-16
Time frame: Baseline, 6 months
To assess perceived social isolation, this study will use the Portuguese-adapted version of the UCLA Loneliness Scale comprising 16 items. This version was culturally and linguistically validated for the Portuguese population, particularly in older adults, ensuring conceptual equivalence while excluding or modifying items less relevant in this context. Each item is rated on a 4-point Likert scale ranging from 1 ("Never") to 4 ("Often"). Total scores range from 16 to 64, with higher scores indicating greater perceived loneliness. The scale assesses key dimensions of loneliness, including feelings of social disconnectedness, lack of companionship, and emotional isolation.
Positive and Negative Affect - PANAS
Time frame: Baseline, 6 months
To evaluate affective states, the study will use the Positive and Negative Affect Schedule (PANAS), a validated self-report instrument measuring two distinct dimensions of mood: Positive Affect (PA) and Negative Affect (NA). The PANAS consists of 20 items, with 10 items assessing PA-enthusiastic, interested, alert, inspired, determined, attentive, active, proud, excited, and strong-and 10 items assessing NA-distressed, upset, guilty, scared, hostile, irritable, ashamed, nervous, jittery, and afraid. Participants rate how much they have experienced each emotion over a specified time frame on a 5-point Likert scale ranging from 1 ("Very slightly or not at all") to 5 ("Extremely"). Scores for each subscale are summed separately, with possible ranges of 10 to 50. Higher PA scores indicate greater positive emotional engagement, while higher NA scores reflect higher levels of distress and negative emotional experience.
Physical Activity
Time frame: Baseline, 6 months
Physical Activity will be tested by Accelerometer-based activity monitors GT3X+ Link (ActiGraph)
Sleep Quality - PSQI-PT
Time frame: Baseline, 6 months
To assess sleep quality, the study will use the Pittsburgh Sleep Quality Index - Portuguese version (PSQI-PT), a widely validated self-report questionnaire designed to measure sleep quality and disturbances over a one-month period. The PSQI-PT consists of 19 items, which generate seven component scores assessing different dimensions of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, and the sum of these yields a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality, with a commonly used cut-off of >5 to distinguish poor sleepers from good sleepers.
fat-free mass
Time frame: baseline, months
fat-free mass (kg), will be analyzed with bioimpedence balance.
fat mass
Time frame: baseline, 6 months
fat mass (%) will be analyzed with bioimpedance balance.
BMI - Body Mass Index
Time frame: baseline, 6 months
BMI (Kg/m^2) will be analyzed with bioimpedance balance.
9 secondary outcomes
Cognitive performance (Memory)
Time frame: Baseline, 6 months
Cognitive performance (Selective recall test)
Time frame: Baseline, 6 months
Cognitive performance (Verbal short-term memory)
Time frame: Baseline, 6 months
Cognitive performance (Inhibition/cognitive flexibility)
Time frame: Baseline, 6 months
Cognitive performance (Processing speed)
Time frame: Baseline, 6 months
Brain Activity
Time frame: Baseline, 6 months
Risk of Falls - FRAX
Time frame: Baseline, 6 months
Perceptions of the experience of participants
Time frame: 6 months
Cognitive Performance (Verbal Working Memory)
Time frame: Baseline, 6 months
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 8 Sep 2025.
- Results publication: PubMed 29428927Rodrigues-Krause J, Krause M, Reischak-Oliveira A. Dancing for Healthy Aging: Functional and Metabolic Perspectives. Altern Ther Health Med. 2019 Jan;25(1):44-63.
- Results publication: PubMed 31316562Vaccaro MG, Izzo G, Ilacqua A, Migliaccio S, Baldari C, Guidetti L, Lenzi A, Quattrone A, Aversa A, Emerenziani GP. Characterization of the Effects of a Six-Month Dancing as Approach for Successful Aging. Int J Endocrinol. 2019 Jun 17;2019:2048391. doi: 10.1155/2019/2048391. eCollection 2019.
- Results publication19- Physical Activity Guidelines Advisory Committee, 2018. Physical Activity Guidelines Advisory Committee Scientific Report. Washington, DC: U.S. Department of Health and Human Services
- Results publication: PubMed 29995884Rehfeld K, Luders A, Hokelmann A, Lessmann V, Kaufmann J, Brigadski T, Muller P, Muller NG. Dance training is superior to repetitive physical exercise in inducing brain plasticity in the elderly. PLoS One. 2018 Jul 11;13(7):e0196636. doi: 10.1371/journal.pone.0196636. eCollection 2018.
- Results publication: PubMed 12674724Wilde NJ, Strauss E, Chelune GJ, Hermann BP, Hunter M, Loring DW, Martin RC, Sherman EM. Confirmatory factor analysis of the WMS-III in patients with temporal lobe epilepsy. Psychol Assess. 2003 Mar;15(1):56-63. doi: 10.1037/1040-3590.15.1.56.
- Results publication: PubMed 9375233Buschke H, Sliwinski M, Kuslansky G, Lipton RB. Aging, encoding specificity, and memory change in the Double Memory Test. J Int Neuropsychol Soc. 1995 Sep;1(5):483-93. doi: 10.1017/s1355617700000576.
- Results publication: PubMed 2771064Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. doi: 10.1212/wnl.39.9.1159.
- Results publication: PubMed 27923147Del Rio Joao KA, Becker NB, de Neves Jesus S, Isabel Santos Martins R. Validation of the Portuguese version of the Pittsburgh Sleep Quality Index (PSQI-PT). Psychiatry Res. 2017 Jan;247:225-229. doi: 10.1016/j.psychres.2016.11.042. Epub 2016 Nov 28.
- Results publication: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Results publication10- Pocinho, M., Farate, C. & Dias, C., (2010). Validação Psicométrica da Escala UCLA-Lonliness para Idosos Portugueses. Interções. 65-77.
- Results publication: PubMed 16367493Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
- Results publication8- World Health Organization. (2021). Obesity and Overweight. Retrieved July 2023 from https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight
- Individual participant dataSharing planned: No. Data will be produced and stored in accordance with the data protection laws and the University of Porto internal regulations. Data collected by questionnaire and direct observation will be anonymized before storage. The sub-investigator will be the only person with access to the grid that contains the data coding. Data will be stored in the official University of Porto cloud and with a copy on a hard disk that will be in the sub-investigator possession.
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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.
José Magalhães, PhD study director
Faculty of Sport, University of Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ballroom Dance and Multicomponent Exercise in people with Physical Activity and Physical Fitness, run by Universidade do Porto 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 2 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2025. 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?
Psychological testing (Depression) - GDS (time frame: Baseline, 6 months). The study lists 20 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 NCT07158866, which also lists 17 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 8 Sep 2025.