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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03095534
Other study ID # 1609528804
Secondary ID
Status Completed
Phase N/A
First received March 20, 2017
Last updated April 12, 2018
Start date March 1, 2017
Est. completion date April 11, 2018

Study information

Verified date April 2018
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study evaluates the feasibility of a staff-lead workout program, 3-Step Workout for Life, in a local senior living community. Eligible participants will complete assessments before and after the workout program.


Description:

The 3-Step Workout for Life program is designed to help older adults improve muscle strength and apply the improved muscle strength to perform activities of daily living. The 10-week workout consists of single-joint resistance exercise, multiple-joint resistance exercise, and activities of daily living exercise. Participants will exercise in small groups in a community room as well as one-on-one with the fitness staff in their home. The community fitness staff will learn the 3-Step Workout for Life program from the University partner and deliver the program.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date April 11, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 60 Years to 90 Years
Eligibility Inclusion Criteria:

1. Aged 60 years old and above

2. Residents of the local study community

3. Communicable in English

4. Took more than 16 seconds to complete five chair stands with arms crossed at the chest.

5. Self-reported difficulty in performing one or more activities of daily living, which must include difficulty in feeding/eating, dressing, grooming/personal hygiene, bathing/showering, using the toilet, or functional mobility/transfer.

Exclusion Criteria:

1. Aged above 90 years old.

2. Unwilling to commit to the study program 3 sessions per week for 10 weeks.

3. Plan to move away from the current community in 6 months.

4. Having three or more errors on a six-item cognitive impairment screener.

5. Having any terminal illness, cardiovascular, neurological, psychiatric, orthopedic, or cognitive impairments that are contraindications to participating in an exercise program.

6. The difficulty of performing activities of daily living is due to neurological disorders (e.g., stroke, Parkinson's), orthopedic conditions (e.g, amputees), or sensory deficits (diabetic palsy, low vision).

7. Physician's recommendation of no moderate physical exercise.

8. Receiving home health rehabilitation therapy or exercise at moderate intensity for more than twice a week (last more than 20 minutes each time).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
3-Step Workout for Life
a 10-week moderate exercise program

Locations

Country Name City State
United States Indiana University (IUPUI Campus) Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Liu CJ, Jones LY, Formyduval A RM, Clark DO. Task-Oriented Exercise to Reduce Activities of Daily Living Disability in Vulnerable Older Adults: A Feasibility Study of the 3-Step Workout for Life. J Aging Phys Act. 2016 Jul;24(3):384-92. doi: 10.1123/japa.2015-0070. Epub 2015 Nov 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Montreal Cognitive Assessment Global cognitive function measure 12 weeks
Other Patient Health Questionnaire (PHQ-9 ) To measure the degree of depression 12 weeks
Other A Three-Item Scale Assessing Pain Intensity and Interference (PEG) To measure the degree of pain and interfering with enjoyment of life and genera activities 12 weeks
Other UCLA Loneliness Scale To measure the degree of loneliness 12 weeks
Other Pearlin Mastery Scale To measure personal mastery 12 weeks
Primary Assessment of Motor and Process Skills (AMPS)-the motor skill scale To measure motor ability required to competently complete daily activities 12 weeks
Secondary Box and Block Test To measure motor coordination of the upper extremity 12 weeks
Secondary Timed Up and Go To measure functional mobility 12 weeks
Secondary 30-second arm curl test To measure muscle strength of the upper extremity 12 weeks
Secondary 30-second chair stand test To measure muscle strength of the lower extremity 12 weeks
Secondary Canadian Occupational Performance Measure To measure self-perception of performance in everyday living 12 weeks
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