UMIN-CTR Clinical Trial

Public title

Effects of television-based home exercise program (TVEx) on frailty: a pilot study

Acronym

A pilot study of the TVEx

Scientific Title

Feasibility, safety, and effectiveness of television-based home exercise program (TVEx) on frailty: a pilot prospective randomized open blinded end-point study

Scientific Title:Acronym

A pilot effectiveness study of the TVEx

Region

Japan

Condition

Frailty

Classification by specialty

Geriatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the feasibility, safety, and effectiveness of the TVEx on frailty.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

Change in the score of Short Physical Performance Battery from baseline to post-intervention (after 12 weeks) surveys.

Key secondary outcomes

[Secondary outcome on the effectiveness]
1. Frailty phenotype score
2. Motor function test (gait performance assessed using the GAITRite System, sit and rearch test, up and go test, and knee extension strength)
3. Cognitive function test (verbal memory, logical memory, Symbol Digit Substitution Task, Trail making Test A and B assessed using the National Center for Geriatrics and Gerontology-Functional Assessment Tool)
4. Body composition test (body fat and fat-free mass assessed using the InBody720)
5. Questionnaires (SF-36, home-based exercise self-efficacy, GDS15, LSNS-6, and Kihon Check List)
6. Blood test (Hb, Ht, BG, TP, Alb, LDH, Fe, TC, LDLC, HDLC, TG, and h-CRP)
7. Lifestyle behavior (habitual dietary intake (brief-type self-administered diet history questionnaire), habitual physical activity (active style pro HJA-750C), sleep condition (ActiGraph GT3X+, the Japanese version of the Pittsburgh Sleep Quality Index))

[Safety]
1. Number of all adverse events that occur during the intervention period
2. Blood test (WBC, RBC, AST, ALT, gamma-GTP, PLT, BUN, and Cr)

[Feasibility]
1. When the participation rate in the TVEx is 75% or more and the withdrawal/dropout rate from the intervention is less than 25%, then we consider it as feasible.
2. Total frequency of participating in the TVEx.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Malnutrition prevention + TVEx program
1. Malnutrition prevention program
Participants will receive four documents that introduce detailed methods for preventing malnutrition in their habitual lifestyle and will be asked to record food variety scores every day.
2. TVEx
Participants will be asked to perform three TVExes (radio calisthenics part-1 and -2, calisthenics for everyone), which provided by NIPPON HOSO KYOKAI or DVD, 1-4 times on everyday.

Interventions/Control_2

Malnutrition prevention program
1. Malnutrition prevention program
Participants will receive four documents that introduce detailed methods for preventing malnutrition in their habitual lifestyle and will be asked to record food variety scores every day.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

100

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Community-dwelling older adults aged 65 to 99 years old.
2. Meeting the revised J-CHS frailty or prefrailty crteria.
3. Providing informed consent.

Key exclusion criteria

1. Diagnosed as dementia or prescribed anti-dementia agency.
2. Having a disability in BADL.
3. Exercise restriction ordered by family doctors, except for light-intensity exercise.
4. Having an unstable medical condition or severe diseases, and not approved to participate in the study by the medical doctor.
5. Having experience of angina or myocardial infarction, have heart surgery within the last 3 months, or who are receiving end-stage disease or palliative care.
6. Participating in radio or television calisthenics 1 day/week in the past month.
7. Participating in specific rehabilitation programs.
8. Not able to walk more than 10 m independently.
9. Participate in other clinical trials
10. Not having a TV.
11. Having difficulty in communication by Japanese.
12. Participation of housemates.
13. Judged to be ineligible as a participant by a principal investigator or medical doctor.

Target sample size

60

Name of lead principal investigator

1st name	Hunkyung
Middle name
Last name	Kim

Organization

Tokyo Metropolitan Institute of Gerontology

Division name

Research Team for Promoting Independence and Mental Health

Zip code

173-0015

Address

35-2, Sakae-cho, Itabashi-ku, Tokyo

TEL

03-3964-3241

Email

kimhk@tmig.or.jp

Name of contact person

1st name	Yosuke
Middle name
Last name	Osuka

Organization

Tokyo Metropolitan Institute of Gerontology

Division name

Research Team for Promoting Independence and Mental Health

Zip code

173-0015

Address

35-2, Sakae-cho, Itabashi-ku, Tokyo

TEL

03-3964-3241

Homepage URL

Email

osuka@tmig.or.jp

Institute

Tokyo Metropolitan Institute of Gerontology

Institute

Department

Personal name

Organization

The Nakatomi Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology

Address

35-2, Sakae-cho, Itabashi-ku, Tokyo

Tel

03-3964-1141

Email

rinsyoushiken@tmghig.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京都健康長寿医療センター研究所

Date of disclosure of the study information

2020

Year

10

Month

12

Day

URL releasing protocol

https://onlinelibrary.wiley.com/doi/10.1111/ggi.14511

Publication of results

Published

URL related to results and publications

https://onlinelibrary.wiley.com/doi/10.1111/ggi.14511

Number of participants that the trial has enrolled

60

Results

Both practice (83%) and retention rates (100%) met the predetermined feasibility criteria. Eleven adverse events were reported but were supposedly unrelated to the intervention. ITT analysis showed that there was no clinically significant difference in the change in SPPB score between groups. On the other hand, the intervention group scored higher in the mental component of HR-QoL than did the control group.

Results date posted

2023

Year

02

Month

28

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

1) community-dwelling older adults aged 65-99 years, 2) meeting pre-frailty or frailty criteria according to the revised Japanese Cardiovascular Health Study, and 3) providing written informed consent.

Participant flow

1. Screening from a trial-ready cohort
2. Recruitment
3. Informed consent
4. Random selection
5. Baseline assessment
6. Random allocation
6. Intervention (12 weeks)
7. Follow-up assessment

Adverse events

Eleven adverse events were reported by intervention participants, and 29 abnormal values in blood parameters were reported. Those seem to be unrelated to the intervention.

Outcome measures

>Primary outcome
Change in the score of Short Physical Performance Battery from baseline to post-intervention (after 12 weeks) surveys.

>Secondary outcomes
1. Frailty phenotype score
2. Motor function test (gait performance assessed using the GAITRite System, sit and rearch test, up and go test, and knee extension strength)
3. Cognitive function test (verbal memory, logical memory, Symbol Digit Substitution Task, Trail Making Test A and B assessed using the National Center for Geriatrics and Gerontology-Functional Assessment Tool)
4. Body composition test (body fat and fat-free mass assessed using the InBody720)
5. Questionnaires (SF-36, home-based exercise self-efficacy, GDS15, LSNS-6, and Kihon Check List)
6. Blood test (Hb, Ht, BG, TP, Alb, LDH, Fe, TC, LDLC, HDLC, TG, and h-CRP)
7. Lifestyle behavior (habitual dietary intake (brief-type self-administered diet history questionnaire), habitual physical activity (active style pro-HJA-750C), sleep condition (ActiGraph GT3X+, the Japanese version of the Pittsburgh Sleep Quality Index))

[Safety]
1. Number of all adverse events that occur during the intervention period
2. Blood test (WBC, RBC, AST, ALT, gamma-GTP, PLT, BUN, and Cr)

[Feasibility]
1. When the participation rate in the TVEx is 75% or more and the withdrawal/dropout rate from the intervention is less than 25%, then we consider it as feasible.
2. Total frequency of participating in the TVEx.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

08

Month

18

Day

Date of IRB

2020

Year

08

Month

18

Day

Anticipated trial start date

2020

Year

10

Month

12

Day

Last follow-up date

2021

Year

08

Month

12

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

10

Month

12

Day

Last modified on

2023

Year

02

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048007