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

NCT03985917 | Completed

• 1 other identifier: Project 626 Sing Group Seniors
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Singing Group; Choir; Intervention; Older Adults; Well-Being; Cognitive Function; General Health

Outcome Measures

Primary Outcomes (28)

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

Study Arms (2)

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).

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.

Other: Alternative Social and Leisure Activities

Interventions

Singing Group Intervention Program OTHER

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.

Also known as: Choir Intervention Program

Intervention Singing Group Program

Alternative Social and Leisure Activities OTHER

Day care centers provide social and leisure activities opportunities for older adults. The control group is free to enroll in these activities.

Also known as: Social and Leisure Activities

Alternative Social and Leisure Activities

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Iolanda Costa Galinha: lead
• DGArtes - Direção Geral das Artes: collaborator
• CIS-Iscte - Centro de Investigação e Intervenção Social: collaborator

Study Sites (1)

Universidade Autónoma de Lisboa

Lisbon, 1150-293, Portugal

Location

Related Publications (3)

• 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.

  PMID: 34378330 DERIVED

• Galinha 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.

  PMID: 34355628 DERIVED

• Galinha 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.

  PMID: 32948120 DERIVED

Related Links

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

MeSH Terms

Conditions

Respiratory Aspiration; Anxiety Disorders; Depression; Social Identification; Medication Adherence; Body Weight

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Social Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Signs and Symptoms

Study Officials

• Iolanda C. Galinha, Ph.D,

  Universidade Autónoma de Lisboa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants, singing group facilitators and researchers conducting the study cannot be blinded to allocation. However, the collection of the data, namely, cognitive, psychosocial, motor and physiologic outcome measures will be assessed by independent researchers, blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 14, 2019
• Study Start: December 5, 2018
• Primary Completion: February 20, 2019
• Study Completion: February 28, 2020
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)