UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036084 |
|---|---|
| Receipt number | R000041110 |
| Scientific Title | Impact of home-based resistance training on risk of fall and cardio-metabolic risks in hypertensive patients with pre-sarcopenia or sarcopenia -A randomized controlled study- |
| Date of disclosure of the study information | 2019/03/08 |
| Last modified on | 2019/03/05 10:48:22 |
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Basic information
Public title
Impact of home-based resistance training on risk of fall and cardio-metabolic risks in hypertensive patients with pre-sarcopenia or sarcopenia -A randomized controlled study-
Acronym
Impact of home-based resistance training on risk of fall and cardio-metabolic risks in hypertensive patients with pre-sarcopenia or sarcopenia -A randomized controlled study-
Scientific Title
Impact of home-based resistance training on risk of fall and cardio-metabolic risks in hypertensive patients with pre-sarcopenia or sarcopenia -A randomized controlled study-
Scientific Title:Acronym
Impact of home-based resistance training on risk of fall and cardio-metabolic risks in hypertensive patients with pre-sarcopenia or sarcopenia -A randomized controlled study-
Region
| Japan |
Condition
Condition
hypertension, sarcopenia
Classification by specialty
| Cardiology | Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to examine the hypothesis if home-based resistance training could improve cardio-metabolic risks and decrease risk of fall in elderly hypertensive patients with pre-sarcopenia or sarcopenia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fall risk index
Key secondary outcomes
Body composition, blood pressure, Brachial-ankle pulse wave velocity, triglyceride, LDL-cholesterol, HDL-cholesterol, glucose, insulin, HOMA-IR, moter function, physical activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
home-based exercise group: lower limb resistance exercises and balance exercise: bird dog crunch, single-leg standing, bicycle crunches, squats, knee ups and calf raises
Interventions/Control_2
The control group: no exercise guidance during the study period
Interventions/Control_3
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
| 53 | years-old | <= |
Age-upper limit
| 88 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(a) age: 50 yrs or over
(b) skeletal muscle mass index (SMI) less than 1SD of the average young Japanese: less than 7.9kg/m2 for men and less than 6.3kg/m2 for women)
Key exclusion criteria
(a) cognitive impairments
(b) neurological disorders
(c) pacemaker use
(d) under treatment of malignant neoplasm (e) diabetes treated with insulin
Target sample size
73
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | masanori munakata |
Organization
Reseach Center for the Promotion of Health and Employment Supports, Tohoku Rosasi Hospital
Division name
Section of preventive medicine
Zip code
Address
3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan
TEL
0222751085
munakata@tohokuh.johas.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | masanori munakata |
Organization
Reseach Center for the Promotion of Health and Employment Supports, Tohoku Rosasi Hospital
Division name
Section of preventive medicine
Zip code
Address
3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan
TEL
0222751085
Homepage URL
munakata@tohokuh.johas.go.jp
Sponsor or person
Institute
Reseach Center for the Promotion of Health and Employment Supports, Tohoku Rosasi Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Organization of Occupational Health and Safty
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 05 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041110
