NCT03095534

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

10 months

First QC Date

March 20, 2017

Last Update Submit

April 12, 2018

Conditions

Frail ElderlyMuscle Weakness

Keywords

Occupational TherapyAging in placeActivities of daily livingCommunity program

Outcome Measures

Primary Outcomes (1)

  • Assessment of Motor and Process Skills (AMPS)-the motor skill scale

    To measure motor ability required to competently complete daily activities

    12 weeks

Secondary Outcomes (5)

  • Box and Block Test

    12 weeks

  • Timed Up and Go

    12 weeks

  • 30-second arm curl test

    12 weeks

  • 30-second chair stand test

    12 weeks

  • Canadian Occupational Performance Measure

    12 weeks

Other Outcomes (5)

  • Montreal Cognitive Assessment

    12 weeks

  • Patient Health Questionnaire (PHQ-9 )

    12 weeks

  • A Three-Item Scale Assessing Pain Intensity and Interference (PEG)

    12 weeks

  • +2 more other outcomes

Study Arms (1)

3-Step Workout for Life

EXPERIMENTAL

Participants will exercise at the moderate intensity three times a week for 10 weeks. The total of 30 workout sessions will consist of 18 sessions of group single-joint resistance exercise, 6 sessions of one-on-one multiple-joint resistance exercise, and 6 sessions of one-on-one activities of daily living exercise. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and lower extremity. During the activities of daily living exercise, participants will practice daily tasks around the home. The community fitness staff will modify the task demand to increase the physical challenge of the task to each participant, for example, increasing travel distance.

Behavioral: 3-Step Workout for Life

Interventions

3-Step Workout for LifeBEHAVIORAL

a 10-week moderate exercise program

3-Step Workout for Life

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 60 years old and above
  • Residents of the local study community
  • Communicable in English
  • Took more than 16 seconds to complete five chair stands with arms crossed at the chest.
  • 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.

You may not qualify if:

  • Aged above 90 years old.
  • Unwilling to commit to the study program 3 sessions per week for 10 weeks.
  • Plan to move away from the current community in 6 months.
  • Having three or more errors on a six-item cognitive impairment screener.
  • Having any terminal illness, cardiovascular, neurological, psychiatric, orthopedic, or cognitive impairments that are contraindications to participating in an exercise program.
  • 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).
  • Physician's recommendation of no moderate physical exercise.
  • Receiving home health rehabilitation therapy or exercise at moderate intensity for more than twice a week (last more than 20 minutes each time).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University (IUPUI Campus)

Indianapolis, Indiana, 46202, United States

Location

Related 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.

    PMID: 26583695BACKGROUND

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Chiung-ju Liu

    Indiana University School of Health & Rehabilitation Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single group with pretest and posttest
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 29, 2017

Study Start

March 1, 2017

Primary Completion

December 31, 2017

Study Completion

April 11, 2018

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

US(1)