Unique ID issued by UMIN | UMIN000018640 |
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Receipt number | R000021567 |
Scientific Title | The effect of Stand/Gait rehabilitation using BCAA and vitamin D high formulated nutritional supplement from the acute phase for inpatients with gait disturbance, Randomized, Open-Label, Comparative Study |
Date of disclosure of the study information | 2015/08/11 |
Last modified on | 2016/09/28 22:01:23 |
The effect of Stand/Gait rehabilitation using BCAA and vitamin D high formulated nutritional supplement from the acute phase for inpatients with gait disturbance, Randomized, Open-Label, Comparative Study
The effect of Stand/Gait rehabilitation using BCAA and vitamin D high formulated nutritional supplement
The effect of Stand/Gait rehabilitation using BCAA and vitamin D high formulated nutritional supplement from the acute phase for inpatients with gait disturbance, Randomized, Open-Label, Comparative Study
The effect of Stand/Gait rehabilitation using BCAA and vitamin D high formulated nutritional supplement
Japan |
Hospitalized patient with gait disturbance
Geriatrics | Rehabilitation medicine |
Others
NO
To investigate the effects of Stand/Gait Training using BCAA and vitamin D high formulated nutritional supplement from the acute phase for inpatients with gait disturbance on ADL, physical activity, skeletal muscle mass and muscle strength.
Efficacy
Exploratory
Pragmatic
Phase III
Motor FIM gain
Assessment in baseline and every month
1.Muscle mass (measured by the InBody S10 every 2 weeks)
2.Muscle strength (mesured by the dynamometer)
3.Swallowing function (FILS, tongue pressure)
4.Cognitive function(HDS-R, FIM)
5.Nutritional assessment(MNA-SF, BMI, Alb, Lymphocyte Count)
6.Gait function (Timed up & go test, 6 minutes-walk test , gait speed )
2-6:Assessment in baseline and every month
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
NO
Institution is not considered as adjustment factor.
YES
2
Treatment
Food |
Stand/Gait training with BCAA and vitamin D high formulated nutritional supplement
1.Jelly type nutritional supplement 2 bags per day
BCAA 2500 mg, vit.D 800iu per one bag of the nutritional supplement
It starts within two weeks from hospitalization
It continues until discharge
2.Stand/Gait training with therapist
Stand/Gait training without BCAA and vitamin D high formulated nutritional supplement
1.Stand/Gait training with therapist
20 | years-old | <= |
Not applicable |
Male and Female
1.FIM score of locomotion is less than 5 or 6 whose gait speed is less than 0.8m/s
2.Stand/Gait training in physical therapy
3.Able to intervene in continuously from the acute phase ward to the recovery phase rehabilitation ward
4.Patient with more than 70% of dietary intake
5.Agreement to participate in the research.
1.Cow's milk allergy, soybean allergy, citrus fruit allergy
2.Severe renal dysfunction (GFR<30)
3.Patients who cannot take in jelly at all
78
1st name | |
Middle name | |
Last name | Misa Moriwaki |
Midorigaoka Hospital
Department of Rehabilitation, medical office
3-13-1Makami-cho,Takatsuki-city,Osaka prefecture
027-681-5975
reha-1@midorigaoka.or.jp
1st name | |
Middle name | |
Last name | Misa Moriwaki |
Midorigaoka Hospital
Department of Rehabilitation, medical office
3-13-1Makami-cho,Takatsuki-city,Osaka prefecture
027-681-5975
reha-1@midorigaoka.or.jp
Midorigaoka Hospital
None
Self funding
NO
社会医療法人祐生会 みどりヶ丘病院(大阪府)
2015 | Year | 08 | Month | 11 | Day |
Unpublished
Completed
2015 | Year | 08 | Month | 07 | Day |
2015 | Year | 08 | Month | 13 | Day |
2016 | Year | 07 | Month | 10 | Day |
2016 | Year | 07 | Month | 10 | Day |
2016 | Year | 07 | Month | 10 | Day |
2016 | Year | 09 | Month | 28 | Day |
2015 | Year | 08 | Month | 11 | Day |
2016 | Year | 09 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021567
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