UMIN-CTR Clinical Trial

Public title

Effects of Weight-Bearing Resistance Training Program among the Community-Dwelling Frail Elderly: A Randomized Controlled Trial

Acronym

Effects of Weight-Bearing Resistance Training Program among the Frail Elderly

Scientific Title

Effects of Weight-Bearing Resistance Training Program among the Community-Dwelling Frail Elderly: A Randomized Controlled Trial

Scientific Title:Acronym

Effects of Weight-Bearing Resistance Training Program among the Frail Elderly

Region

Japan

Condition

Disuse syndrome

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the comprehensive effects (physical, psychological, behavioral, and economical effects) of the weight-bearing resistance training program available to practice at home among frail elderly with deterioration in physical and psychological functions.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Measurement: pre-post intervention, 3- and 9-month follow-up; Outcomes: physical functions (upper and lower muscular strength, walking ability, functional mobility, static and dynamic balance), psychological functions [health-related quality of life (HRQOL), exercise-specified subjective health physical status, instrumental activities of daily living (IADL)], behavioral functions (objective-measured physical activity, subjective-measured walking, physical activity self-efficacy, stage of changes for physical activity)
Economical evaluation: 1-,2- and 3-year measurement after intervention; Economical outcome: Certification of needed long-term care

Key secondary outcomes

Measurement: pre-post intervention, 3- and 9-month follow-up; Fall-prevention related outcomes: history of falling, frequency of previous falling, fall-prevention self-efficacy

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

NO

Concealment

Pseudo-randomization

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Within the community-dwelling elderly who participate in the community functional checkup for the long-term care prevention, those who agree with participation in the present study and meet the inclusion criteria will be randomly assigned with either the weight-bearing resistance training (WRT) group (n=50) or the long-term care prevention education (LPE), group (n=50). The WRT group participates in 12-week (total 12 sessions) the WRT program, of which the duration is 90 minutes per session once a week. On the purpose of increasing in the antigravity-muscular strength (lower-limb muscle group), the WRT program are developed based on "Chokin Exercise Instructor Manual:Resistance Training for the elderly"(Fukunaga, 2006). The number of exercise and repetition of each exercise is progressively increased as their strength improves. Behavioral approach to practice and habituate the learned WRT at home is intensively provided using a printed booklet.

Interventions/Control_2

The LPE group participates in the 12-week educational class aimed at increase in knowledge of and practical skills for the long-term care prevention (12 sessions, 90 minutes of duration, once per week). The major topics of the educational class are as follows: basic purpose and meaning of the long-term care prevention; improving the function of the organ of locomotion, nutrition, and oral functions; preventing the dementia.

Interventions/Control_3

Within the community-dwelling elderly who participate in the community functional checkup for the long-term care prevention, those who disagree with participation in the present study but agree with providing their information of a care need certification or a support need certification is assigned with the control group (n=50). They only include in economical evaluation.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

The community-dwelling elderly aged over 65 years with risk of physical weakness and falling.

Key exclusion criteria

(1) cerebrovascular or cardiovascular events reported within
the past 6 months
(2) angina, chronic heart failure, uncontrolled cardiac dysrhythmias
(3) systolic blood pressure
above 180 mm Hg or diastolic blood pressure above 110 mm Hg
at rest
(4)Shortness of breath and dyspnea with Chronic obstructive pulmonary disease (chronic bronchitis and emphysema)
(5) Serious complications of diabetes mellitus (diabetic retinopathy and nephropathy)
(6) Acute neuromuscular, musculoskeletal, or rheumatoid disorders
(7) Acute pneumonia and active phase
of chronic hepatitis
(8) Other general medical morbidity that would be prohibited the exercises from the physician

Target sample size

150

Name of lead principal investigator

1st name
Middle name
Last name	Koichiro Oka

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code

Address

2-579-15 Mikajima Tokorozawa, Saitama

TEL

04-2947-6781

Email

Name of contact person

1st name
Middle name
Last name	Koichiro Oka

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code

Address

2-579-15 Mikajima Tokorozawa, Saitama

TEL

04-2947-6781

Homepage URL

Email

koka@waseda.jp

Institute

Faculty of Sport Sciences, Waseda University

Institute

Department

Personal name

Organization

Waseda University Grant for Special Research Projects

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京都豊島区

Date of disclosure of the study information

2010

Year

01

Month

26

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Grip test (upper muscular strength) and 5-time stand-to-sit test (lower muscular strength) in the WRT group significantly increased after the intervention period compared with these in the LPE group. Additionally, Timed up & go test (functional mobility), 5-meter maximal and normal walk test (walking ability), and 7 subscales of SF-36 (HRQOL) in both groups significantly improved after the intervention period. (Japan Society of Sports Industry Annual Meeting, Oral presentation. July 12. 2009)

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2007

Year

04

Month

30

Day

Date of IRB

Anticipated trial start date

2007

Year

06

Month

01

Day

Last follow-up date

2011

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

01

Month

26

Day

Last modified on

2010

Year

01

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003755