Ignite Creation Date:
2024-07-17 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-28
Brief Title:
Group Drumming for Improving the Health of Community-Dwelling Elderly
Sponsor:
KK Womens and Childrens Hospital
Organization:
KK Womens and Childrens Hospital
Study Overview
Official Title:
Group Drumming for Improving the Health of Community-Dwelling Elderly
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study seeks to examine the effects that recreational group drumming has on the health of the community- dwelling elderly It is hypothesized that it has positive and sustainable effects on various health outcome measures
Detailed Description:
The study seeks to examine the effects that recreational group drumming has on the health of the community- dwelling elderly It is hypothesized that it has positive and sustainable effects on various health outcome measures
One of the primary outcome measure is the quality of life of the participants which will be measured using the European Quality of Life-5 Dimensions EQ5D It is a measure of health status from the EuroQoL Group primarily designed for self-completion by respondents and is validated locally The score ranges from 0 death to 1 full health with 5 dimensions comprising of mobility self-care usual activities paindiscomfort and anxiety depression
The other primary outcome measures include
i The Geriatric Depression Scale GDS which is a tool used for elderly population to evaluate the level of depressive symptoms of an individual over the past week has been validated locally It is a self-reported questionnaire consisting of 15 items Maximum score of 15 and minimum of 0 Score equal or greater than 6 out of 15 is considered to be indicator of depression
ii The Pittsburgh Sleep Quality Index PSQI is a self-reported measure of sleep quality It is a 19-item scale grouped into 7 equally weighted component scores The global score ranges from 0 to 21 with poorer sleep quality indicated by a higher global score
iii Social Effects The Lubben Social Network Scale LSNS is a self-reported measure designed to gauge social isolation in the elderly It measures frequency size and closeness of contacts for the participants social network by assessing the participants perceived level of support received from friends and families
The secondary outcomes are broadly categorized into psychological effects social effects and physical effects as listed below
1 Psychological Effects The Mini Mental State Examination MMSE is a commonly used screening tool for cognitive impairment worldwide A score of less than 25 out of maximum of 30 is often suggestive of an underlying cognitive impairment
2 Physical Effects
i Resting blood pressure and heart rate
ii Grip strength - popular indicator of physical functioning
iii Minnesota Manual Dexterity Test
It is hypothesized that recreational group drumming has positive and sustainable effects on various health outcome measures
The research study will be conducted in two phases Phase 1 is the randomized controlled study comparing the intervention with independent concurrent controls Phase 2 will involve providing the intervention to the control subjects from phase 1 where subjects act as their own controls pre to post intervention
Each drumming session would have 20 participants excluding two facilitators This Bridging Rhythm with Wellness Programme will be organised by Lions Befrienders Singapore These drumming sessions will be held in the Active Ageing Centres AACs under Lions Befirenders
Recruited study participants will be issued Study ID upon enrolment into study Phase 1 Phase 1 is a randomized controlled trial with a planned ratio of participants of 11 in the intervention group Group A and control group Group B Unlike the pilot study a crossover will not be conducted in view of i difficulties in quantifying a sufficient washout period for such an intervention and ii a possible learned effect being carried over
Participants will be recruited from senior activity centre and randomized into either group within their respective senior activity centre
All participants in phase 1 be it those randomised into control or intervention group will be subjected to the following study procedures
Clinical and patient related outcome data will be collected at the participants respective senior activity centres at 4 time points
1 At the start of the study
2 Midpoint of intervention Week 4
3 Completion of intervention Week 8
4 4 Weeks post-intervention Week 12 For assessments done at first study timepoint ie start of study assessments it can be completed 2-3 weeks prior to commencement of each centres drumming session This is to allow study team members to have time to complete the required baseline assessments prior to commencement of study intervention
All study assessments to be completed within study timepoint week with 3 working date window period before and after study timepoint week
Participants will be asked to complete the following questionnaires and clinical tests
1 European Quality of Life-5 Dimensions EQ5D
2 Geriatric Depression Scale GDS
3 Pittsburgh Sleep Quality Index PSQI
4 Mini Mental State Examination MMSE
5 Lubben Social Network Scale LSNS
6 Katz ADL
7 Blood Pressure
8 Heart Rate
9 Grip Strength with Dynamometer
10 Minnesota Manual Dexterity Test
11 Study Data Collection Form Study participants may be contacted via phone calls to complete required questionnaires Participants will be provided a research letter if any incidental finding have been found
Phase 2 In phase 2 subjects in Group B or control group in phase 1 will be offered the opportunity to undergo the intervention at least 4 weeks after the intervention group has concluded Phase 1 Being control subjects in phase 1 these subjects have the baseline values for various measures accurately established prior to intervention These subjects will act as their own controls and the effect of the intervention will be assessed by comparing the post treatment values against the baseline measures prior to intervention
Similar outcome measures will be measured at the time points relative to the baseline measurements for both phase 1 and phase 2 studies
Subjects Group A of phase 1 and subjects of phase 2 will undergo a group drumming course under the Bridging Rhythm with Wellness Programme comprising of 8 weekly sessions that last for an hour each Participants cannot be blinded in the study as whoever playing instruments will be aware of the intervention To protect against contamination participants of the two groups will be assessed at different times
In this group drumming course a variety of percussion instruments will be used inn these sessions including the conga cowbell Djembe Ashiko Tan-tans Dunun shakers and wood blocks These instruments will be rotated among the participants from session to session Participants will be seated comfortably in a circle on chairs within their assigned group and the percussion instrument will be placed in front of them within reach Each session will be led by 2 experienced artist-facilitators skilled in leading group drumming courses 1 fixed main facilitator 1 co-facilitator The artist-facilitators will be blinded to the participants backgrounds psychological and physical health profiles Artist-facilitators will encourage free play expression and interaction amongst participants through playing of instruments
One of the primary outcome measure is the quality of life of the participants which will be measured using the European Quality of Life-5 Dimensions EQ5D It is a measure of health status from the EuroQoL Group primarily designed for self-completion by respondents and is validated locally The score ranges from 0 death to 1 full health with 5 dimensions comprising of mobility self-care usual activities paindiscomfort and anxiety depression
The other primary outcome measures include
i The Geriatric Depression Scale GDS which is a tool used for elderly population to evaluate the level of depressive symptoms of an individual over the past week has been validated locally It is a self-reported questionnaire consisting of 15 items Maximum score of 15 and minimum of 0 Score equal or greater than 6 out of 15 is considered to be indicator of depression
ii The Pittsburgh Sleep Quality Index PSQI is a self-reported measure of sleep quality It is a 19-item scale grouped into 7 equally weighted component scores The global score ranges from 0 to 21 with poorer sleep quality indicated by a higher global score
iii Social Effects The Lubben Social Network Scale LSNS is a self-reported measure designed to gauge social isolation in the elderly It measures frequency size and closeness of contacts for the participants social network by assessing the participants perceived level of support received from friends and families
The secondary outcomes are broadly categorized into psychological effects social effects and physical effects as listed below
1 Psychological Effects The Mini Mental State Examination MMSE is a commonly used screening tool for cognitive impairment worldwide A score of less than 25 out of maximum of 30 is often suggestive of an underlying cognitive impairment
2 Physical Effects
i Resting blood pressure and heart rate
ii Grip strength - popular indicator of physical functioning
iii Minnesota Manual Dexterity Test
It is hypothesized that recreational group drumming has positive and sustainable effects on various health outcome measures
The research study will be conducted in two phases Phase 1 is the randomized controlled study comparing the intervention with independent concurrent controls Phase 2 will involve providing the intervention to the control subjects from phase 1 where subjects act as their own controls pre to post intervention
Each drumming session would have 20 participants excluding two facilitators This Bridging Rhythm with Wellness Programme will be organised by Lions Befrienders Singapore These drumming sessions will be held in the Active Ageing Centres AACs under Lions Befirenders
Recruited study participants will be issued Study ID upon enrolment into study Phase 1 Phase 1 is a randomized controlled trial with a planned ratio of participants of 11 in the intervention group Group A and control group Group B Unlike the pilot study a crossover will not be conducted in view of i difficulties in quantifying a sufficient washout period for such an intervention and ii a possible learned effect being carried over
Participants will be recruited from senior activity centre and randomized into either group within their respective senior activity centre
All participants in phase 1 be it those randomised into control or intervention group will be subjected to the following study procedures
Clinical and patient related outcome data will be collected at the participants respective senior activity centres at 4 time points
1 At the start of the study
2 Midpoint of intervention Week 4
3 Completion of intervention Week 8
4 4 Weeks post-intervention Week 12 For assessments done at first study timepoint ie start of study assessments it can be completed 2-3 weeks prior to commencement of each centres drumming session This is to allow study team members to have time to complete the required baseline assessments prior to commencement of study intervention
All study assessments to be completed within study timepoint week with 3 working date window period before and after study timepoint week
Participants will be asked to complete the following questionnaires and clinical tests
1 European Quality of Life-5 Dimensions EQ5D
2 Geriatric Depression Scale GDS
3 Pittsburgh Sleep Quality Index PSQI
4 Mini Mental State Examination MMSE
5 Lubben Social Network Scale LSNS
6 Katz ADL
7 Blood Pressure
8 Heart Rate
9 Grip Strength with Dynamometer
10 Minnesota Manual Dexterity Test
11 Study Data Collection Form Study participants may be contacted via phone calls to complete required questionnaires Participants will be provided a research letter if any incidental finding have been found
Phase 2 In phase 2 subjects in Group B or control group in phase 1 will be offered the opportunity to undergo the intervention at least 4 weeks after the intervention group has concluded Phase 1 Being control subjects in phase 1 these subjects have the baseline values for various measures accurately established prior to intervention These subjects will act as their own controls and the effect of the intervention will be assessed by comparing the post treatment values against the baseline measures prior to intervention
Similar outcome measures will be measured at the time points relative to the baseline measurements for both phase 1 and phase 2 studies
Subjects Group A of phase 1 and subjects of phase 2 will undergo a group drumming course under the Bridging Rhythm with Wellness Programme comprising of 8 weekly sessions that last for an hour each Participants cannot be blinded in the study as whoever playing instruments will be aware of the intervention To protect against contamination participants of the two groups will be assessed at different times
In this group drumming course a variety of percussion instruments will be used inn these sessions including the conga cowbell Djembe Ashiko Tan-tans Dunun shakers and wood blocks These instruments will be rotated among the participants from session to session Participants will be seated comfortably in a circle on chairs within their assigned group and the percussion instrument will be placed in front of them within reach Each session will be led by 2 experienced artist-facilitators skilled in leading group drumming courses 1 fixed main facilitator 1 co-facilitator The artist-facilitators will be blinded to the participants backgrounds psychological and physical health profiles Artist-facilitators will encourage free play expression and interaction amongst participants through playing of instruments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None