Cognitive FunctionSing4HealthNCT03985917
Singing Groups for Seniors: Well-Being, Cognitive Function and Health
A study testing Singing Group Intervention Program and Alternative Social and Leisure Activities in people with Cognitive Function and Well-Being, run by Iolanda Costa Galinha at 1 site in Portugal.
Trial summary
The researchers' implement and measure the effects of a singing group intervention program for older adults, with an RCT design, in a natural context, on the health, well-being and cognitive function of 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
- Cognitive Function, Well-Being, Physical Function
- What is being tested?
- Singing Group Intervention Program and Alternative Social and Leisure Activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Dec 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 60 years old or older;
- Retired;
- Accept the invitation to participate in the singing group program;
- Not having participated in other intervention programs in the previous four months.
Who cannot join
- Having a severe impairment, that is disabling for the participation in the singing group activity (e.g. severe cognitive, auditory, visual or mobility impairments).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Grupos de Canto Para Seniores" Despacho Nº 11409-C/2017, Projeto n.º 626, From Orçamento Participativo Portugal, Ministério da Cultura
The researchers' implement and measure the effects of a singing group intervention program for older adults, with an RCT design, in a natural context, on the health, well-being and cognitive function of older adults.
Read the detailed description
Background: Singing is a multimodal activity that requires physical, cognitive and psychosocial performance, with benefits in various domains of health and well-being of older adults. In recent years, research has increasingly studied group singing as an important cost-effective intervention to promote active and healthy aging. However, the specific factors responsible for these benefits need further experimental support, as most studies do not allow for causal inferences. This study responds to the need for further randomized controlled trials (RCT), with follow-up measurement, on the benefits of group singing in older adults with diverse socioeconomic status. Also, while most studies often focus on specific outcome measures dimensions, in this study, the conjoint effects of physical, psychosocial, emotional and cognitive dimensions are analyzed, testing mediation and moderation effects of psychosocial and cognitive variables in the health and well-being of the participants. Methods: The team implements and measures the effects of a singing group program for older adults, with an RCT design, in a natural context, before and after the intervention and in a follow-up, four months after the intervention. Participants: 140 retired older adults (> 60 years), users of a social care institution, were invited to participate in a singing group program and randomly allocated to an experimental intervention group (n = 70), and a control (n = 70) group enrolled in the regular activities proposed by the institution. The intervention consists of 34 bi-weekly group singing sessions, of two-hours each, for four months. Measures on social and emotional well-being, cognitive function, and health indicators (as blood pressure, glycemia, cholesterol, c-reactive protein, erythrocyte sedimentation rate, respiratory function, body balance, body activity, sleep quality, medication intake, and health services attendance) will be collected. Interviews on the motivation and perceived benefits of participation will also be collected. Discussion: Significant improvements are expected in the outcome measures in the experimental group after the intervention, in comparison with the control group and the pretest, validating the singing group program as a cost-effective intervention for healthy aging. Psychoemotional, psychosocial and cognitive variables are expected to be mediators of the effects of the program on the health and well-being of the participants.
- Conditions
- Cognitive Function, Well-Being, Physical Function, Respiratory Function, Memory, Biomarker
- Being tested
- Singing Group Intervention Program, Alternative Social and Leisure Activities
- Keywords
- Singing Group, Choir, Intervention, Older Adults, Well-Being, Cognitive Function, General Health
- Medical subject headings
- Respiratory Aspiration, Anxiety Disorders, Depression, Social Identification, Medication Adherence, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Singing Group Intervention ProgramOther
Also called Choir Intervention Program
Each session will start with (1) relaxation, vocal warm-up and breething exercises; (2) vocal technique training; (3) memorization and interpretation of music and lyrics; (4) session breaks of 20 minutes for socialization; (5) preparation of a final choir show; (6) vocal tuning tests.
Alternative Social and Leisure ActivitiesOther
Also called Social and Leisure Activities
Day care centers provide social and leisure activities opportunities for older adults. The control group is free to enroll in these activities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Singing Group Program | Experimental | Singing group intervention program that includes six components: (1) vocal warm-up exercises; (2) vocal technique; (3) rehearsal of repertoire; (4) break for socialization; (5) creation and presentation of a show; (6) assessment of participants performance (vocal tuning). Receives: Other: Singing Group Intervention Program |
| Alternative Social and Leisure Activities | Active comparator | While the experimental group is participating in the intervention program, the control group will participate in the other activities proposed by the day care centers, which will be registered. Receives: Other: Alternative Social and Leisure Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life - WHOQOL-BREF
The WHOQOL-BREF measures the subjective perception of quality of life. It consists of 26 items, of which two items measure global quality of life and 24 items measure four dimensions. In this study the (1) Physical health, (2) Psychological Health, (3) Social relationships will be measured. The items are answered in a 5 point scale, from 1 (Very Bad; Very Unsatisfied; Nothing; Never) to 5 (Very Good; Very Satisfied; Extremely; Always).
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Quality of Life - WHOQOL-OLD
The WHOQOL-OLD measures the quality of life specifically for older adults, with 28 items, measuring six dimensions. In this study the dimensions (1) sensory abilities; (2) autonomy; (3) past, present, and future activities; and (4) social participation will be measured. The items are answered in a 5-point scale, from 1 (Nothing; Very Bad; Very Unsatisfied) to 5 (Extremely; Very Good; Very Satisfied).
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Depression, Anxiety and Stress - Dass 21
The DASS 21 measures Anxiety, Depression and Stress. Consists of 21 items distributed in 3 subscales of 7 items each, answered on a 4-point scale, ranging from: 0 "It did not apply to me", to 3 "Applied to me most of the time".
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Positive and Negative Affect - PANAS
Measures the frequency of positive and negative emotions, during the past four months, and consists of two scales with 10 items each, answered on a 5-point scale from: 1 "nothing or very slightly"; to 5 "extremely".
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Life Satisfaction - SWLS
Measures satisfaction with life in general, according to the persons' criteria. Consists of five items, answered on a 5-point scale from: 1 = strongly disagree; to 5 - I agree very much.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Self-Esteem - RSES
Measures the appreciation of self-worth and self-acceptance, with 10 items, answered on a 4-point Likert scale, from: 1 = strongly disagree; to 4 = strongly agree.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Loneliness - UCLA Loneliness Scale
Measures the feeling of being cut off from others, with four items, derived from the longer version of the ULS-20, answered on a 4-point scale from: 0 (Never), to 4 (Often / Many Times).
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Social Identification - FISI
Measures the emotional evaluation of the relationship between the self and the ingroup, with four items, answered on a 7-point scale, ranging from: 1 "strongly disagree", to 7 "strongly agree".
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Social Well-Being - Scale of Social Well-Being
Measures a multidimensional construct of social well-being including the dimensions: social acceptance, social coherence, social actualization, social integration and social contribution. Constituted by 33 items, answered on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree).
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Cognitive Function - MoCA
Measures six cognitive functions: executive function; visuospatial skills; short-term memory; language; attention, concentration and working memory; and temporal and spatial orientation. The test is constituted by six groups of tasks and exercises. The maximum score is 30 points; higher scores indicate better cognitive performance.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Short-term auditory verbal memory - RAVELT
The scale measures the rate of verbal learning, learning strategies, retroactive, and proactive interference, presence of confabulation or confusion in memory processes, retention of information, and differences between learning and retrieval. It consists of a list of 15 unrelated words repeated over five different trials, which participants are asked to repeat.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Attention and Executive Function - Trail Making Test
The test measures the processing speed, mental flexibility, and divided attention. It consists of a task of connecting a trail of numbers with a drawing line. In this study, TMT A will be used, providing two direct scores: time to complete part A and performance errors.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Processing Speed - Digit Symbol Test
The test measures the processing speed of non-verbal information. It consists of a task of drawing figures corresponding to numbers. It also measures cognitive and motor speed, planning ability, visual memory, visuomotor coordination, motivation to perform the task and attention.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Blood Pressure - Licensed laboratory
Measures the pressure with which the blood circulates within the arteries. Data collected and analyzed by a licensed laboratory.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Pulse - Licensed laboratory
The count of arterial pulse per minute, measures the number of times the heart beats per minute. Data collected and analyzed by a licensed laboratory.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Glycemia - Blood sample - Licensed laboratory
Measures the amount of glucose present in the blood, used in the diagnosis and treatment of several diseases as diabetes mellitus or hypoglycemia. Data is collected and analyzed by a licensed laboratory.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Cholesterol - Blood sample - Licensed laboratory
Measures total cholesterol, a fatty substance produced by the liver, present in all body cells and essential for the formation of the cell membranes hormone synthesis, digestion of fats, production of bile, metabolism of vitamins A, D, E and K, important in the constitution of global coronary disease risk. Data is collected and analyzed by a licensed laboratory.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
C-reactive protein (CRP) - Blood sample - Licensed laboratory
Measures C-reactive protein, a protein produced in the liver and in case of inflammatory states its production increases. Indicates an ongoing, but not specific, organism infection. It can also be high in case of neoplasia. Data collected and analyzed by a licensed laboratory.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Erythrocyte Sedimentation Rate (ESR) - Blood sample - Licensed laboratory
A measure of the red blood cells sedimentation by micro photometry over a period of time. A blood sedimentation rate is tested to detect inflammation in the body or to follow the progress of a disease. Data is collected and analyzed by a licensed laboratory.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Body Weight - Professional scale
Body weight is assessed by weighing the person with light clothing, without shoes and while fasting.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Respiratory Function - Spirometry (Medikro Pro) - Air Volume
The test consists of a simple examination, which allows to globally evaluate how the lungs are functioning by measuring the volume of air (measured in litres with the tests FVC, FEV1 and FEV6). In addition the Tiffeneau-Pinelli Index will be measured, which is a ratio between FVC and FEV1. Data is collected by trained researchers in motricity sciences.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Respiratory Function - Spirometry (Medikro Pro) - Air Speed
The test consists of a simple examination, which allows to globally evaluate how the lungs are functioning by measuring the speed of air expired (litres per second, measured with the tests PEF, FEF 25 to 75%). Data is collected by trained researchers in motricity sciences.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Body Balance - Unipedal Stance Test.
The participant is instructed to balance on a foot of their choosing for up to 20 seconds. The number of seconds in balance is registered as the score of this test. Data collected by trained researchers in motricity sciences.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Physical Activity - Actigraphy (GT3X accelerometer)
Actigraphy registers the body accelerations in three axes (vertical, antero-posterior, and medio-lateral). Participants will be asked to wear the accelerometer around the hip for seven consecutive days (day and night, except when bathing). The accelerometer provides a measure of the frequency, intensity, and duration of physical activity and allows for the classification of activity levels as sedentary, light, moderate and vigorous.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Sleep Quality - Actigraphy (GT3X accelerometer)
Actigraphy registers the body accelerations in three axes (vertical, antero-posterior, and medio-lateral). Participants will be asked to wear the accelerometer around the hip for seven consecutive days (day and night, except for bathing). The accelerometer provides a measure of the frequency, intensity, and duration of physical activity and allows for a measure of the total duration of sleep.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Pain Perception - The Brief Pain Inventory,
The scale measures different types of pain, with nine questions: a first one that is optional; a second one based on drawings of the human body to locate the pain in the body; four items about pain intensity (worst pain, least pain, average pain, pain right now); two items on pain relief or medication; and one item on pain interference, with seven sub-items (general activity, mood, walking ability, normal walk, relations with other people, sleep, and enjoyment of life). Answering options from: 0 "No pain / Did not interfered"; and 10 "The greatest pain possible / Completely interfered".
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Medication Intake - Social Support Institution
Medication and dosage are registered and supplied by the Social Care Institution to the research team with the authorization of the participants.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Health Services Attendance - Social Support Institution
Number and type of health services appointments registered and supplied by the Social Care Institution to the research team with the authorization of the participants.
Measured: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start5 Dec 2018
- Primary completion20 Feb 2019
- Study completion28 Feb 2020
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 Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were recruited by invitation in the day-care centers, nursing homes and home care units run by Santa Casa da Misericórdia (a Portuguese Charity Institution, partner in the project). All older adults received an invitation with a brief description of the program and the study. In case they were interested in participating, they were invited to a meeting where the musical intervention team provided additional information about the intervention and clarified any questions from the participants. At the end of the session a detailed informed consent was signed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iolanda Costa Galinha
- Sponsor type
- University, hospital or other
- Collaborators
- DGArtes - Direção Geral das Artes, CIS-Iscte - Centro de Investigação e Intervenção Social
- Responsible party
- Sponsor-investigator, Iolanda Costa Galinha, Universidade Autónoma de Lisboa
- Investigators
- Iolanda C. Galinha, Ph.D,, Study director, Universidade Autónoma de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985917
- Sponsor's protocol ID
- Project 626 Sing Group Seniors
- Acronym
- Sing4Health
- Status last verified
- May 2023
- First submitted
- 29 May 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galinha IC, Garcia-Martin MA, Lima ML. Sing4Health: Randomised controlled trial of the effects of a singing group program on the subjective and social well-being of older adults. Appl Psychol Health Well Being. 2022 Feb;14(1):176-195. doi: 10.1111/aphw.12297. Epub 2021 Aug 10.
PubMed 34378330Galinha IC, Fernandes HM, Lima ML, Palmeira AL. Intervention and mediation effects of a community-based singing group on older adults' perceived physical and mental health: the Sing4Health randomized controlled trial. Psychol Health. 2023 Jan;38(1):73-93. doi: 10.1080/08870446.2021.1955117. Epub 2021 Aug 6.
PubMed 34355628Galinha IC, Farinha M, Lima ML, Palmeira AL. Sing4Health: protocol of a randomized controlled trial of the effects of a singing group intervention on the well-being, cognitive function and health of older adults. BMC Geriatr. 2020 Sep 18;20(1):354. doi: 10.1186/s12877-020-01686-6.
PubMed 32948120
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Grupos de Canto Para Seniores" Despacho Nº 11409-C/2017, Projeto n.º 626, From Orçamento Participativo Portugal, Ministério da Cultura
- ClinicalTrials.gov ID
- NCT03985917
- Acronym / sponsor ID
- Sing4Health / Project 626 Sing Group Seniors
- Conditions
- Cognitive Function, Well-Being, Physical Function, Respiratory Function, Memory, Biomarker
- Keywords
- Singing Group, Choir, Intervention, Older Adults, Well-Being, Cognitive Function, General Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Iolanda Costa GalinhaUniversity, hospital or other
- Collaborators
- DGArtes - Direção Geral das Artes, CIS-Iscte - Centro de Investigação e Intervenção Social
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 14 Jun 2019 (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.
The researchers' implement and measure the effects of a singing group intervention program for older adults, with an RCT design, in a natural context, on the health, well-being and cognitive function of older adults.
Detailed description
Background: Singing is a multimodal activity that requires physical, cognitive and psychosocial performance, with benefits in various domains of health and well-being of older adults. In recent years, research has increasingly studied group singing as an important cost-effective intervention to promote active and healthy aging. However, the specific factors responsible for these benefits need further experimental support, as most studies do not allow for causal inferences. This study responds to the need for further randomized controlled trials (RCT), with follow-up measurement, on the benefits of group singing in older adults with diverse socioeconomic status. Also, while most studies often focus on specific outcome measures dimensions, in this study, the conjoint effects of physical, psychosocial, emotional and cognitive dimensions are analyzed, testing mediation and moderation effects of psychosocial and cognitive variables in the health and well-being of the participants. Methods: The team implements and measures the effects of a singing group program for older adults, with an RCT design, in a natural context, before and after the intervention and in a follow-up, four months after the intervention. Participants: 140 retired older adults (> 60 years), users of a social care institution, were invited to participate in a singing group program and randomly allocated to an experimental intervention group (n = 70), and a control (n = 70) group enrolled in the regular activities proposed by the institution. The intervention consists of 34 bi-weekly group singing sessions, of two-hours each, for four months. Measures on social and emotional well-being, cognitive function, and health indicators (as blood pressure, glycemia, cholesterol, c-reactive protein, erythrocyte sedimentation rate, respiratory function, body balance, body activity, sleep quality, medication intake, and health services attendance) will be collected. Interviews on the motivation and perceived benefits of participation will also be collected. Discussion: Significant improvements are expected in the outcome measures in the experimental group after the intervention, in comparison with the control group and the pretest, validating the singing group program as a cost-effective intervention for healthy aging. Psychoemotional, psychosocial and cognitive variables are expected to be mediators of the effects of the program on the health and well-being of the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were recruited by invitation in the day-care centers, nursing homes and home care units run by Santa Casa da Misericórdia (a Portuguese Charity Institution, partner in the project). All older adults received an invitation with a brief description of the program and the study. In case they were interested in participating, they were invited to a meeting where the musical intervention team provided additional information about the intervention and clarified any questions from the participants. At the end of the session a detailed informed consent was signed.
| Arm | Type | Receives |
|---|---|---|
| Intervention Singing Group Program | Experimental | Other: Singing Group Intervention ProgramSinging group intervention program that includes six components: (1) vocal warm-up exercises; (2) vocal technique; (3) rehearsal of repertoire; (4) break for socialization; (5) creation and presentation of a show; (6) assessment of participants performance (vocal tuning). |
| Alternative Social and Leisure Activities | Active comparator | Other: Alternative Social and Leisure ActivitiesWhile the experimental group is participating in the intervention program, the control group will participate in the other activities proposed by the day care centers, which will be registered. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 60 years old or older;
- Retired;
- Accept the invitation to participate in the singing group program;
- Not having participated in other intervention programs in the previous four months.
Key exclusion criteria (1 listed)
- Having a severe impairment, that is disabling for the participation in the singing group activity (e.g. severe cognitive, auditory, visual or mobility impairments).
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 |
|---|---|---|
| Singing Group Intervention ProgramAlso: Choir Intervention ProgramEach session will start with (1) relaxation, vocal warm-up and breething exercises; (2) vocal technique training; (3) memorization and interpretation of music and lyrics; (4) session breaks of 20 minutes for socialization; (5) preparation of a final choir show; (6) vocal tuning tests. | Other | Intervention Singing Group Program |
| Alternative Social and Leisure ActivitiesAlso: Social and Leisure ActivitiesDay care centers provide social and leisure activities opportunities for older adults. The control group is free to enroll in these activities. | Other | Alternative Social and Leisure Activities |
Primary outcome
Quality of Life - WHOQOL-BREF
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
The WHOQOL-BREF measures the subjective perception of quality of life. It consists of 26 items, of which two items measure global quality of life and 24 items measure four dimensions. In this study the (1) Physical health, (2) Psychological Health, (3) Social relationships will be measured. The items are answered in a 5 point scale, from 1 (Very Bad; Very Unsatisfied; Nothing; Never) to 5 (Very Good; Very Satisfied; Extremely; Always).
Quality of Life - WHOQOL-OLD
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
The WHOQOL-OLD measures the quality of life specifically for older adults, with 28 items, measuring six dimensions. In this study the dimensions (1) sensory abilities; (2) autonomy; (3) past, present, and future activities; and (4) social participation will be measured. The items are answered in a 5-point scale, from 1 (Nothing; Very Bad; Very Unsatisfied) to 5 (Extremely; Very Good; Very Satisfied).
Depression, Anxiety and Stress - Dass 21
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
The DASS 21 measures Anxiety, Depression and Stress. Consists of 21 items distributed in 3 subscales of 7 items each, answered on a 4-point scale, ranging from: 0 "It did not apply to me", to 3 "Applied to me most of the time".
Positive and Negative Affect - PANAS
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Measures the frequency of positive and negative emotions, during the past four months, and consists of two scales with 10 items each, answered on a 5-point scale from: 1 "nothing or very slightly"; to 5 "extremely".
Life Satisfaction - SWLS
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Measures satisfaction with life in general, according to the persons' criteria. Consists of five items, answered on a 5-point scale from: 1 = strongly disagree; to 5 - I agree very much.
Self-Esteem - RSES
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Measures the appreciation of self-worth and self-acceptance, with 10 items, answered on a 4-point Likert scale, from: 1 = strongly disagree; to 4 = strongly agree.
Loneliness - UCLA Loneliness Scale
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Measures the feeling of being cut off from others, with four items, derived from the longer version of the ULS-20, answered on a 4-point scale from: 0 (Never), to 4 (Often / Many Times).
Social Identification - FISI
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Measures the emotional evaluation of the relationship between the self and the ingroup, with four items, answered on a 7-point scale, ranging from: 1 "strongly disagree", to 7 "strongly agree".
Social Well-Being - Scale of Social Well-Being
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Measures a multidimensional construct of social well-being including the dimensions: social acceptance, social coherence, social actualization, social integration and social contribution. Constituted by 33 items, answered on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree).
Cognitive Function - MoCA
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Measures six cognitive functions: executive function; visuospatial skills; short-term memory; language; attention, concentration and working memory; and temporal and spatial orientation. The test is constituted by six groups of tasks and exercises. The maximum score is 30 points; higher scores indicate better cognitive performance.
Short-term auditory verbal memory - RAVELT
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
The scale measures the rate of verbal learning, learning strategies, retroactive, and proactive interference, presence of confabulation or confusion in memory processes, retention of information, and differences between learning and retrieval. It consists of a list of 15 unrelated words repeated over five different trials, which participants are asked to repeat.
Attention and Executive Function - Trail Making Test
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
The test measures the processing speed, mental flexibility, and divided attention. It consists of a task of connecting a trail of numbers with a drawing line. In this study, TMT A will be used, providing two direct scores: time to complete part A and performance errors.
Processing Speed - Digit Symbol Test
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
The test measures the processing speed of non-verbal information. It consists of a task of drawing figures corresponding to numbers. It also measures cognitive and motor speed, planning ability, visual memory, visuomotor coordination, motivation to perform the task and attention.
Blood Pressure - Licensed laboratory
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Measures the pressure with which the blood circulates within the arteries. Data collected and analyzed by a licensed laboratory.
Pulse - Licensed laboratory
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
The count of arterial pulse per minute, measures the number of times the heart beats per minute. Data collected and analyzed by a licensed laboratory.
Glycemia - Blood sample - Licensed laboratory
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Measures the amount of glucose present in the blood, used in the diagnosis and treatment of several diseases as diabetes mellitus or hypoglycemia. Data is collected and analyzed by a licensed laboratory.
Cholesterol - Blood sample - Licensed laboratory
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Measures total cholesterol, a fatty substance produced by the liver, present in all body cells and essential for the formation of the cell membranes hormone synthesis, digestion of fats, production of bile, metabolism of vitamins A, D, E and K, important in the constitution of global coronary disease risk. Data is collected and analyzed by a licensed laboratory.
C-reactive protein (CRP) - Blood sample - Licensed laboratory
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Measures C-reactive protein, a protein produced in the liver and in case of inflammatory states its production increases. Indicates an ongoing, but not specific, organism infection. It can also be high in case of neoplasia. Data collected and analyzed by a licensed laboratory.
Erythrocyte Sedimentation Rate (ESR) - Blood sample - Licensed laboratory
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
A measure of the red blood cells sedimentation by micro photometry over a period of time. A blood sedimentation rate is tested to detect inflammation in the body or to follow the progress of a disease. Data is collected and analyzed by a licensed laboratory.
Body Weight - Professional scale
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Body weight is assessed by weighing the person with light clothing, without shoes and while fasting.
Respiratory Function - Spirometry (Medikro Pro) - Air Volume
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
The test consists of a simple examination, which allows to globally evaluate how the lungs are functioning by measuring the volume of air (measured in litres with the tests FVC, FEV1 and FEV6). In addition the Tiffeneau-Pinelli Index will be measured, which is a ratio between FVC and FEV1. Data is collected by trained researchers in motricity sciences.
Respiratory Function - Spirometry (Medikro Pro) - Air Speed
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
The test consists of a simple examination, which allows to globally evaluate how the lungs are functioning by measuring the speed of air expired (litres per second, measured with the tests PEF, FEF 25 to 75%). Data is collected by trained researchers in motricity sciences.
Body Balance - Unipedal Stance Test.
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
The participant is instructed to balance on a foot of their choosing for up to 20 seconds. The number of seconds in balance is registered as the score of this test. Data collected by trained researchers in motricity sciences.
Physical Activity - Actigraphy (GT3X accelerometer)
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Actigraphy registers the body accelerations in three axes (vertical, antero-posterior, and medio-lateral). Participants will be asked to wear the accelerometer around the hip for seven consecutive days (day and night, except when bathing). The accelerometer provides a measure of the frequency, intensity, and duration of physical activity and allows for the classification of activity levels as sedentary, light, moderate and vigorous.
Sleep Quality - Actigraphy (GT3X accelerometer)
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Actigraphy registers the body accelerations in three axes (vertical, antero-posterior, and medio-lateral). Participants will be asked to wear the accelerometer around the hip for seven consecutive days (day and night, except for bathing). The accelerometer provides a measure of the frequency, intensity, and duration of physical activity and allows for a measure of the total duration of sleep.
Pain Perception - The Brief Pain Inventory,
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
The scale measures different types of pain, with nine questions: a first one that is optional; a second one based on drawings of the human body to locate the pain in the body; four items about pain intensity (worst pain, least pain, average pain, pain right now); two items on pain relief or medication; and one item on pain interference, with seven sub-items (general activity, mood, walking ability, normal walk, relations with other people, sleep, and enjoyment of life). Answering options from: 0 "No pain / Did not interfered"; and 10 "The greatest pain possible / Completely interfered".
Medication Intake - Social Support Institution
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Medication and dosage are registered and supplied by the Social Care Institution to the research team with the authorization of the participants.
Health Services Attendance - Social Support Institution
Time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Number and type of health services appointments registered and supplied by the Social Care Institution to the research team with the authorization of the participants.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 34378330Galinha IC, Garcia-Martin MA, Lima ML. Sing4Health: Randomised controlled trial of the effects of a singing group program on the subjective and social well-being of older adults. Appl Psychol Health Well Being. 2022 Feb;14(1):176-195. doi: 10.1111/aphw.12297. Epub 2021 Aug 10.
- Derived from this study: PubMed 34355628Galinha IC, Fernandes HM, Lima ML, Palmeira AL. Intervention and mediation effects of a community-based singing group on older adults' perceived physical and mental health: the Sing4Health randomized controlled trial. Psychol Health. 2023 Jan;38(1):73-93. doi: 10.1080/08870446.2021.1955117. Epub 2021 Aug 6.
- Derived from this study: PubMed 32948120Galinha IC, Farinha M, Lima ML, Palmeira AL. Sing4Health: protocol of a randomized controlled trial of the effects of a singing group intervention on the well-being, cognitive function and health of older adults. BMC Geriatr. 2020 Sep 18;20(1):354. doi: 10.1186/s12877-020-01686-6.
- Projeto n.º 626, from Orçamento Participativo Portugal, Ministério da CulturaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iolanda C. Galinha, Ph.D, study director
Universidade Autónoma de Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singing Group Intervention Program and Alternative Social and Leisure Activities in people with Cognitive Function and Well-Being, run by Iolanda Costa Galinha 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 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life - WHOQOL-BREF (time frame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).). The study lists 28 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 NCT03985917, 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 10 May 2023.