Singing Groups for Seniors: Well-Being, Cognitive Function and Health

Depression Clinical Trial

— Sing4Health  

Official title:

"Grupos de Canto Para Seniores" Despacho Nº 11409-C/2017, Projeto n.º 626, From Orçamento Participativo Portugal, Ministério da Cultura

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985917
• Other study ID #: Project 626 Sing Group Seniors
• Status: Completed
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: May 2023
• Source: Universidade Autónoma de Lisboa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 28, 2020
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• Having a severe impairment, that is disabling for the participation in the singing group activity (e.g. severe cognitive, auditory, visual or mobility impairments).

Related Conditions & MeSH terms

• Anxiety
• Balance
• Biomarker
• Blood Glucose
• Blood Pressure
• Body Weight
• C-reactive Protein
• Cholesterol
• Cognitive Function
• Depression
• Erythrocyte Sedimentation Rate
• Health Complaint, Subjective
• Loneliness
• Medication Compliance
• Memory
• Pain Perception
• Physical Function
• Quality of Life
• Respiratory Function
• Sleep
• Social Identification
• Stress
• Well-Being

Intervention

Other:
• Singing Group 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 Activities
Day care centers provide social and leisure activities opportunities for older adults. The control group is free to enroll in these activities.

Locations

Country	Name	City	State
Portugal	Universidade Autónoma de Lisboa	Lisbon

Sponsors (3)

Lead Sponsor	Collaborator
Iolanda Costa Galinha	CIS-Iscte - Centro de Investigação e Intervenção Social, DGArtes - Direção Geral das Artes

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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).	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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".	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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".	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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).	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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".	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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).	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	Blood Pressure - Licensed laboratory	Measures the pressure with which the blood circulates within the arteries. Data collected and analyzed by a licensed laboratory.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	Body Weight - Professional scale	Body weight is assessed by weighing the person with light clothing, without shoes and while fasting.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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".	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Primary	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.	Change from baseline at 4 months (post-test) and at 10 months (follow-up).

External Links

•   Projeto n.º 626, from Orçamento Participativo Portugal, Ministério da Cultura