Clinical trial NCT03985917: Singing Groups for Seniors: Well-Being, Cognitive Function and Health
Official title: "Grupos de Canto Para Seniores" Despacho Nº 11409-C/2017, Projeto n.º 626, From Orçamento Participativo Portugal, Ministério da Cultura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Universidade Autónoma de Lisboa
Sponsor class: OTHER
Collaborators: name: DGArtes - Direção Geral das Artes
name: CIS-Iscte - Centro de Investigação e Intervenção Social
First posted: 2019-06-14
Enrollment: 140
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Quality of Life - WHOQOL-BREF
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Quality of Life - WHOQOL-OLD
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Depression, Anxiety and Stress - Dass 21
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Positive and Negative Affect - PANAS
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Life Satisfaction - SWLS
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Self-Esteem - RSES
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Loneliness - UCLA Loneliness Scale
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Social Identification - FISI
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Social Well-Being - Scale of Social Well-Being
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Cognitive Function - MoCA
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Short-term auditory verbal memory - RAVELT
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Attention and Executive Function - Trail Making Test
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Processing Speed - Digit Symbol Test
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Blood Pressure - Licensed laboratory
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Pulse - Licensed laboratory
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Glycemia - Blood sample - Licensed laboratory
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Cholesterol - Blood sample - Licensed laboratory
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: C-reactive protein (CRP) - Blood sample - Licensed laboratory
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Erythrocyte Sedimentation Rate (ESR) - Blood sample - Licensed laboratory
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Body Weight - Professional scale
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Respiratory Function - Spirometry (Medikro Pro) - Air Volume
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Respiratory Function - Spirometry (Medikro Pro) - Air Speed
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Body Balance - Unipedal Stance Test.
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Physical Activity - Actigraphy (GT3X accelerometer)
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Sleep Quality - Actigraphy (GT3X accelerometer)
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Pain Perception - The Brief Pain Inventory,
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Medication Intake - Social Support Institution
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
measure: Health Services Attendance - Social Support Institution
timeFrame: Change from baseline at 4 months (post-test) and at 10 months (follow-up).
Secondary outcomes:
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Universidade Autónoma de Lisboa
Study officials:
affiliation: Universidade Autónoma de Lisboa
name: Iolanda C. Galinha, Ph.D,
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.