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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03607136
Other study ID # IRB106-75-A-2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2018
Est. completion date July 2020

Study information

Verified date July 2018
Source Buddhist Tzu Chi General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the effects of exercise intervention on muscle strength and walking speed for the community-dwelling elderly. Half of the participants will receive exercise training, while the other half will maintain their usual activities of daily living.


Description:

Physical inactivity can result in physical frailty and sarcopenia. Physical frailty and sarcopenia are two common and mostly overlapping geriatric conditions, which may cause negative consequences of aging, such as disability, hospitalization and mortality.

Regular physical activity has been suggested to maintain or improve functional capacity and body composition, as well as delay aging process. Nevertheless, inactivity prevalence still significantly increases among older adults, especially those with a disability. One of the probable reasons is that the use of physical activities or exercise interventions is not tailored to the needs and capabilities of the elderly.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date July 2020
Est. primary completion date July 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

- age greater than 50 years

- able to follow simple instructions

- willing to participate and sign consent form

Exclusion Criteria:

- unstable angina or epilepsy

- severe visual deficits

- cognitive dysfunction

- other musculoskeletal conditions that will limit mobility

Study Design


Related Conditions & MeSH terms


Intervention

Other:
exercise training
Aerobic exercises, strengthening exercises, flexibility training for 60min, twice a week for 12 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Buddhist Tzu Chi General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Walking speed Participants are asked to walk along a 14 m hallway. The time taken to the middle 10 m is recorded to calculate walking speed (m/s). Change from baseline at 12 weeks
Primary Muscle strength Muscle strength is assessed using hand-hold Dynamometers Change from baseline at 12 weeks
Secondary Timed up and go test Participants are asked to stand up, walk 3 m, turn around a cone, and return to a sitting position Change from baseline at 12 weeks
Secondary Walking endurance Participants are asked to walk back and forth along a 20-meter corridor and to cover the maximum distance possible in six minutes Change from baseline at 12 weeks
Secondary Sit-to-stand test Participants are asked to stand up and sit down 5 times. Change from baseline at 12 weeks
Secondary Berg balance scale It consists of 14 items, including sitting unsupported, standing unsupported, standing with eyes closed, standing with feet together, standing on one foot, turning to look behind, retrieving objective from floor, random standing, reaching forward with an outsrptretched arm, sit to stand, stand to sit, transfer, turning 360 degrees, stool stepping, scored from 0 to 4, "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56. Change from baseline at 12 weeks
Secondary Gait kinematics Gait kinematics are assessed by angular displacement of lower limbs using shoe-worn inertial measurement unit based device Change from baseline at 12 weeks
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