UMIN-CTR Clinical Trial

Public title

Improvement in Cognitive and Motor Functions of Healthy Older Adults Following a Dance Program Intervention: A Randomized Controlled Trial

Acronym

Cognitive and Motor Functions Following a Dance Program Intervention

Scientific Title

Improvement in Cognitive and Motor Functions of Healthy Older Adults Following a Dance Program Intervention: A Randomized Controlled Trial

Scientific Title:Acronym

Cognitive and Motor Functions Following a Dance Program Intervention

Region

Japan

Condition

Dementia, Mild Cognitive Impairment, Normal elderly, Lewy body dementia, Cerebrovascular disease, Cerebral infarction, Cerebral contusion, Cerebral hemorrhage, Aftereffect of cerebral hemorrhage, Basilar artery occlusion, Cerebral arteriosclerosis, Multiple cerebral infarction, Cerebral atrophy, Vascular dementia, Chronic subdural hematoma, Parkinson's disease, Parkinsonian syndrome, Bone and joint disease, Osteoporosls, Chronic articular rheumatism, Hemiparesis, Diabetes, Disuse syndrome, Locomotive Syndrome, Sarcopenia and frailty.

Classification by specialty

Psychiatry

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to examine the beneficial effect on cognitive and physical function by the dance program.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The Stroop test is compared before and after intervention for four weeks.

Key secondary outcomes

The neuropsychological testing and assessment for dementia (Mini-Mental State Examination, Instruction manual of the Japanese version of Montreal Cognitive Assessment, A Frontal Assessment Battery at bedside), Geriatric Depression Scale, WHO Quality of Life-BREF, the range of motion of the upper and lower limbs, the short physical performance battery test (balance testing, walk for 4 meters, repeated chair stands), grip strength, toe strength, standing calf raise test, bioelectrical impedance analysis (muscle mass (kg), skeletal muscle mass index (kg/m2), ECW/TBW), and respiratory function test (FVC, FEV1, FIV1).

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

The dance intervention group attends 45 minutes of the dance program thrice a week for 4 weeks. After each program, take 8g of protein-containing food.

Interventions/Control_2

The walking intervention group attends 45 minutes of a nordic walking program thrice a week for 4 weeks. After each program, take 8g of protein-containing food.

Interventions/Control_3

The wait listed group does not participate in the intervention. Take 8g of protein-containing food 3 times a week. After 4 weeks, there is the program as a service session.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

60

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) No dementia.
2) No exercised more than an hour per week.
3) Continue to participate in the experiment for 4 weeks.
4) No heart disease, no respiratory disease.
5) Understand Japanese.

Key exclusion criteria

1) Dementia, heart disease and respiratory disease.
2) Blind, full deafness.
3) Regular exercise or training at least once a week.
4) Cannot walk for 45 minutes.

Target sample size

90

Name of lead principal investigator

1st name	Atsuko
Middle name
Last name	Miyazaki

Organization

RIKEN

Division name

Computational Engineering Applications Unit

Zip code

351-0198

Address

2-1 Hirosawa, Wako, Saitama 351-0198 Japan

TEL

+81(0)48-467-4952

Email

atsuko.miyazaki.vj@riken.jp

Name of contact person

1st name	Atsuko
Middle name
Last name	Miyazaki

Organization

RIKEN

Division name

Computational Engineering Applications Unit

Zip code

351-0198

Address

2-1 Hirosawa, Wako, Saitama 351-0198 Japan

TEL

+81(0)48-467-4952

Homepage URL

Email

atsuko.miyazaki.vj@riken.jp

Institute

RIKEN

Institute

Department

Personal name

Organization

Avex Entertainment Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

RIKEN, Bio Safety and Ethics Section

Address

2-1 Hirosawa, Wako, Saitama 351-0198 Japan

Tel

048-467-9293

Email

human@riken.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

株式会社 AT (神奈川県）

Date of disclosure of the study information

2019

Year

11

Month

29

Day

URL releasing protocol

https://www.mdpi.com/1660-4601/19/10/6202

Publication of results

Published

URL related to results and publications

https://www.mdpi.com/1660-4601/19/10/6202

Number of participants that the trial has enrolled

90

Results

We conducted a single-blind randomized controlled trial with 90 healthy older adults who were randomly assigned into the Nordic walking (aerobic exercise), dance (dual-task training with aerobic exercise), or control group. We found that both exercise intervention groups showed improvements in executive function, while the dance group showed additional improvement in global cognitive function. The dance group showed a higher maximum gait speed and more significant improvement in imitation ability.

Results date posted

2022

Year

05

Month

31

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Among the final 88 participants (mean age, 67.81 years; SD=5.64), no one had ADL issues, 29.55% were women, and 47.73% had full- or part-time jobs. The IADL score was 100%. Moreover, 94.31% had a perfect score for intellectual ADL, while 5.68% did not read the newspaper. For social ADL, 31.82% had a perfect score; the rest had a low score because they refrained from social activities due to COVID19. Furthermore, 56.82% of the participants had no exercise habits, while 18.18% performed regular exercise and 25.00% had exercise habits including competition. Participants had a mean education history of 15.58 years (SD=1.5663). Their MMSE-J scores were above the cutoff of 23 points, with a mean score of 28.20 (SD=1.45) points. The mean MoCA score was 26.80 (SD=1.76) points, which was also above the cutoff of 25 points.
All participants could perform the three standing balance tests (side-by-side, semi-tandem, and tandem) for 10 s and the FTSST. Regarding frailty, 2.27% of the participants mentioned unintentional weight loss of =>5% over the past 2 years. For the GDS-15 sub-item, Do you feel that you are full of vitality?, 25% answered No. Therefore, no participants were classified as frail for more than two items, as per the Study of Osteoporotic Fractures Index, and 27.27% of participants were classified as pre-frail (classified as frail for one item).
The mean calf circumference among women was 34.27 cm (SD=2.12), which is above the Asian Working Group for Sarcopenia (AWGS) cutoff of 33 cm for sarcopenia. Even for men, the mean calf circumference exceeded the AWGS cutoff of 34 cm, with a mean of 36.32 cm (SD=2.65). The mean maximum grip strength (20.72 kg) in women exceeded the AWGS cutoff of 18 kg for sarcopenia (SD=3.29; range). Similarly, the mean maximum grip strength for men (31.18 kg) exceeded the AWGS cutoff of 28 kg (SD=8.31). The mean SMI for women was 6.03 kg/m2 (SD=0.40), which is above the AWGS cutoff for sarcopenia (5.8 kg/m2). Men also exceeded the AWGS sarcopenia cutoff of 7.0 kg/m2, with a mean of 7.65 kg/m2 (SD=0.76). One participant had a hip prosthesis and five had an anterior cruciate ligament (ACL) injury, all of whom were >10 years post-treatment and had a good prognosis. Upon physical examination, 43.18% of participants had osteoarthritis of the knee (27 in one leg and 11 in both legs)

Participant flow

All interventions were conducted at the participants' homes. Each program was performed 3 days per week for 4 weeks, according to the participant's schedule. The participants spread out their training days throughout the week. The participants were required to record notes on their training and protein intake on scheduled days. On the final day of the study, they were asked to submit these notes. To be included in the analysis, they had to attend at least nine out of the 12 sessions. Cognitive and physical functioning was measured before the initiation (pre-test) and after completion (post-test) of the program.

Adverse events

No

Outcome measures

Cognitive function, physical function, imitation ability, gait ability, mood index, and body composition measurements

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2019

Year

11

Month

29

Day

Date of IRB

2019

Year

11

Month

29

Day

Anticipated trial start date

2019

Year

12

Month

09

Day

Last follow-up date

2020

Year

03

Month

15

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

11

Month

29

Day

Last modified on

2022

Year

05

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044161