The effect of exercise and nutrition on gait parameters in community-dwelling elderly women with walking disability

JRCT ID: jRCT1090220167

Registered date:06/03/2014

Basic Information

• Recruitment status: COMPLETED
• Health condition(s) or Problem(s) studied: Walking disability
• Date of first enrollment: 12/07/2013
• Target sample size: 130
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention type:BEHAVIOUR
Name of intervention:Exercise + placebo intervention ,Nutritional intervention ,Exercise + nutrition intervention
Dose form / Japanese Medical Device Nomenclature:OTHER,TABLET,OTHER
Route of administration / Site of application:NOT APPLICABLE,ORAL,NOT APPLICABLE
Dose per administration:60,0.5,60
60,1,60
minutes,grams,minutes
Dosing frequency / Frequency of use:BIW,BID,BIW
2 times a week,Every day,2 times a week
Planned duration of intervention:3 months,3 months,3 months
Intended dose regimen:Exercise: 60 minute classes 2 times a week, for 3 months
Placebo: 1 g a day, every day.,1 g per day, every day, 3 months,Exercise: 60 minute classes twice a week, 3 months
Nutrition: 1 g per day, every day, 3 months
detailes of teratment arms:
Comparative intervention name:Placebo intervention
Dose form / Japanese Medical Device Nomenclature:TABLET
Route of administration / Site of application:ORAL
Dose per administration:0.5
1
gram
Dosing frequency / Frequency of use:BID
Every day
Planned duration of intervention:3 months
Intended dose regimen:1 g per day, every day, three months

Outcome(s)

• Primary Outcome: Gait patterns and parameters
• Secondary Outcome: Body composition, blood components

Key inclusion & exclusion criteria

• Age minimum: >= 79age old
• Age maximum: Not applicable
• Gender: Female
• Include criteria: Community-dwelling elderly women, declines in walking speed
• Exclude criteria: Severe knee of back pain, severely impaired mobility (unable to walk without the assistance of another person), impaired cognition, unstable cardiac conditions

Related Information

• Primary Sponsor: Hunkyung Kim
• Source(s) of Monetary Support: Global R&D Human Health Care of the KAO corporation
• Secondary ID(s): Nill Known,JMA-IIA00167