Senior's Ankle-weight Fall-prevention Exercise: A pilot study on Enhancing Balance Function

JRCT ID: jRCT1040230152

Registered date:14/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy Elderly Residents in the Community
• Date of first enrollment: 14/02/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): The exercise program conducted by the intervention group involves a gymnastics routine named "Nagoya Doeryaa Exercise," which includes the use of ankle weights. The program is implemented for 12 weeks, with a frequency of once a week at the Nagoya City University Naruko Community Health Center(CHC Center) and at least twice a week at home. In the event of inclement weather, holidays, or when participants cannot gather at the Nagoya City University Naruko CHC Center, the exercise will be conducted at home with a frequency of three times a week or more.

Outcome(s)

• Primary Outcome: The statistical difference in Timed Up and Go test measurements between the non-intervention group and the intervention group after 12 weeks.

Secondary Outcome

1)The statistical difference in Timed Up and Go test measurements between the non-intervention group and the intervention group at the second assessment point.
2)The statistical difference in the proportion of individuals who achieved 60 seconds in the Timed Up and Go test at both the second and third assessment points between the non-intervention group and the intervention group in the Eyes Open Single Leg Standing Test.
3)The statistical difference in Center of Pressure (COP) measurements between the non-intervention group and the intervention group using a postural sway meter at the second and third assessment points.
4)The statistical difference in the measurements of the 30-second Chair Stand Test between the non-intervention group and the intervention group at the second and third assessment points.
5)The statistical difference in walking speed measurements between the non-intervention group and the intervention group at the second and third assessment points.
6)The statistical difference in the total scores of the Short Falls Efficacy Scale-International (Short FES-I) between the non-intervention group and the intervention group at the second and third assessment points.
7)The statistical difference in the total scores of the Basic Checklist between the non-intervention group and the intervention group at the second and third assessment points.
8)The statistical difference in Skeletal Muscle Mass Index between the non-intervention group and the intervention group at the second and third assessment points.
9)The statistical difference in measurements of lower leg circumference between the non-intervention group and the intervention group at the second and third assessment points.

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

The study participants will be individuals who meet all of the following selection criteria. However, individuals meeting one or more exclusion criteria will be excluded.
1)Age at the time of registration is 65 years or older, for both males and females.
2)Not certified as requiring support or long-term care.
3)Capable of independent daily living, with a score of 12 or more for males and 10 or more for females on the Motor Fitness Scale out of a total of 14 points.
4)Scoring 3 points or more on the Mini-Cog.
5)Participants who have provided written informed consent for participation in this study.

Exclude criteria

If any of the following criteria apply, individuals will be excluded.
1)Individuals requiring prohibition or restriction of movement, as well as restrictions on eating or drinking, due to advanced functional impairment (including bone and joint diseases, renal failure, ischemic heart diseases, and impairments in cardiopulmonary function).
2)Individuals diagnosed with heart disease, hypertension, arrhythmia, or similar conditions requiring bed rest.
3)Individuals experiencing acute joint pain, arthritis, or neurological symptoms.
4)Individuals with osteoporosis and vertebral compression fractures.
5)Individuals diagnosed with dementia.
6)Individuals scoring below 12 points for males and below 10 points for females on the Motor Fitness Scale out of a total of 14 points.
7)Individuals scoring less than 3 points on the Mini-Cog.
8)Individuals unable to converse in Japanese.
9)Individuals for whom tests such as the motor function assessment are not feasible.

Related Information

• Primary Sponsor: Miyazaki kei
• Secondary Sponsor: Kawade Yoshihiro