Singing Groups for Seniors: Well-Being, Cognitive Function and Health (Sing4Health)

May 8, 2023 updated by: Iolanda Costa Galinha

"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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisbon, Portugal, 1150-293
        • Universidade Autónoma de Lisboa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Singing Group Program
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).
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.
Other Names:
  • Choir Intervention Program
Active Comparator: Alternative Social and Leisure Activities
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.
Other: 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.
Other Names:
  • Social and Leisure Activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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).
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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".
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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".
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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).
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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".
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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).
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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".
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).
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.
Change from baseline at 4 months (post-test) and at 10 months (follow-up).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iolanda Costa Galinha

Collaborators

DGArtes - Direção Geral das Artes
CIS-Iscte - Centro de Investigação e Intervenção Social

Investigators

  • Study Director: Iolanda C. Galinha, Ph.D,, Universidade Autónoma de Lisboa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2018

Primary Completion (Actual)

February 20, 2019

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (Actual)

June 14, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project 626 Sing Group Seniors

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Singing Group Intervention Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe