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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003093
Receipt No. R000003755
Scientific Title Effects of Weight-Bearing Resistance Training Program among the Community-Dwelling Frail Elderly: A Randomized Controlled Trial
Date of disclosure of the study information 2010/01/26
Last modified on 2010/01/26

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Basic information
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
Condition Disuse syndrome
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Faculty of Sport Sciences, Waseda University
Institute
Department

Funding Source
Organization Waseda University Grant for Special Research Projects
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京都豊島区

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
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

Progress
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
Other related information

Management information
Registered date
2010 Year 01 Month 26 Day
Last modified on
2010 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003755

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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