The Effect of a Novel Dual-Task Exercise Program for Balance, Mobility and Cognition in Community Dwelling Older Adults

NCT01940055 | Completed Phase 2

• 1 other identifier: Not yet recruiting
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Goal: The development of a Treadmill Rehabilitation Platform (TRP) for task-orientated rehabilitation that provides an adapted, blended approach among older adults with balance, mobility, and cognitive impairments. Study Objective: Examine the feasibility and benefits of a novel dual-task intervention to address mobility and cognitive decline with age using engaging interactive video games during treadmill walking and recumbent cycling.This will include evaluation of the effects of two interventions, one using treadmill walking and the second a recumbent cycle ergometer on

1. 1.Core balance
2. 2.Cardiac fitness, exercise endurance
3. 3.Gaze control
4. 4.Gait performance measure (walking stability and spatial-temporal gait parameters)
5. 5.Specific executive cognitive function (processing speed, cognitive inhibition, working memory)
6. 6.Dual task function during treadmill walking
7. 7.Dual-task exercise program will improve core balance and walking function to a greater extent in the Treadmill walking group compared to recumbent cycle group.
8. 8.Executive function will improve equally in both the treadmill walking and recumbent cycle group.
9. 9.Dual task exercise programs will have significant effect on gaze stability and cardiac fitness equally for both the treadmill and recumbent cycling groups.

Conditions

Aging

Keywords

Balance; Gait; Instrumented Treadmill; Recumbent cycle; Cognitive games

Outcome Measures

Primary Outcomes (5)

• Dual task function during walking

  Walking on at treadmill at a speed of 0.9 m/s while performing a cognitive game task simultaneously i.e the participants move a paddle (game sprite to catch bright circle objects(targets)moving vertically top to bottom, avoiding other shape(or colors) game objects (dis-tractors). This test game provides an objective quantification of cognitive functions like (i) Game success rate (percentage of target caught), (ii) average motor response time (time from appearance of the target to start of the paddle movement), (iii) average movement execution time (iv) movement efficiency .

  Pre and post intervention of 10 weeks

• Executive function

  Neuropsychological tests:Trail making test (A and B), Verbal Fluency, Visual Search and the dimensional change card sort test

  Pre and post intervention of 10 weeks

• Core Balance

  I t will be measured by performing a) Clinical Test of Sensory Integration of Balance and b) Five - Time Sit-to-Stand Test

  Pre and post intervention of 10 weeks

• Spatial - temporal gait variables

  It will be measured by asking the participants to walk on a treadmill for 2 minutes which is instrumented with a pressure mat at a speed of 0.9 m/s. Average and coefficient of variation will be obtained for the following parameters: swing time, step time, step length and step width.

  Pre and post intervention of 10 weeks

• Cardiac fitness

  Cycle ergometer Submaximal Test will be performed measuring the heart rate, blood pressure, revolution per minute and rate of perceived exertion at an interval of 5 minutes.

  Pre and post Intervention of 10 weeks

Secondary Outcomes (2)

• 6- Minute walk test

  Pre and post intervention of 10 weks

• CHAMPS Questionnaire

  Post intervention of 10 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Dual Task Treadmill Walking Exercise Program

Behavioral: Dual task treadmill walking exercise program

Control group

ACTIVE COMPARATOR

Dual task recumbent cycling exercise program

Behavioral: Dual task recumbent cycling exercise program

Interventions

Dual task treadmill walking exercise program BEHAVIORAL

Participants will receive 5 minute warm up and cool down session followed by a 30 minute dual task program which includes treadmill walking while playing brain fitness or cognitive games. Rest periods will be provides to the participants. Treadmill speed will be set so as to not exceed 60% of maximum heart rate. Heart rate and perceived excretion( per the Borg 1-10) will be measured at 5 minutes of interval.

Experimental group

Dual task recumbent cycling exercise program BEHAVIORAL

Participants will receive a 5 minute warm up and cool down session followed by a 30 minute dual task exercise program which includes recumbent cycling while playing brain fitness or cognitive games. Rest periods will be provides to the participants. Recumbent cycling speed will be set so as to achieve 60% of maximum heart rate. Heart rate and perceived excretion( per the Borg 1-10) will be measured at 5 minutes of interval.

Control group

Eligibility Criteria

• Age: 70 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age between 70-80 years old.
• Independent community dwelling
• Walk 400 meters without a walking aid or using a single-point stick only.
• Mini mental status test score greater than 24
• Experiencing no more than one fall in the previous 12 months.
• Having concerns about their balance which is based on participants' positive response to the question: "Are you concerned about your balance?"
• Adequate hearing and vision

You may not qualify if:

• Clinical diagnosis of dementia and a Mini Mental State Exam score less than 24,
• Self-reported diagnosis or history of (i) stroke, traumatic brain injury or other neurological disorders such as Parkinson's disease and Vestibular disorders, (ii) cardiac disease, and (iii) muscular-skeletal injuries or orthopaedic diseases such as acute lower back or lower extremity pain, peripheral neuropathy, advanced hip/knee osteoporosis.
• Any recent medical illness that would affect their balance or ability to walk for a period of at least 6 minutes.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Reh Fit Center

Winnipeg, Manitoba, R3M 3V8, Canada

Location

Related Publications (3)

• Szturm T, Betker AL, Moussavi Z, Desai A, Goodman V. Effects of an interactive computer game exercise regimen on balance impairment in frail community-dwelling older adults: a randomized controlled trial. Phys Ther. 2011 Oct;91(10):1449-62. doi: 10.2522/ptj.20090205. Epub 2011 Jul 28.

  PMID: 21799138 BACKGROUND

• Lockery D, Peters JF, Ramanna S, Shay BL, Szturm T. Store-and-feedforward adaptive gaming system for hand-finger motion tracking in telerehabilitation. IEEE Trans Inf Technol Biomed. 2011 May;15(3):467-73. doi: 10.1109/TITB.2011.2125976.

  PMID: 21536526 BACKGROUND

• Szturm T, Maharjan P, Marotta JJ, Shay B, Shrestha S, Sakhalkar V. The interacting effect of cognitive and motor task demands on performance of gait, balance and cognition in young adults. Gait Posture. 2013 Sep;38(4):596-602. doi: 10.1016/j.gaitpost.2013.02.004. Epub 2013 Mar 9.

  PMID: 23477841 BACKGROUND

Study Officials

• Akshata V Nayak, MSc Student

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Rehab Alhasani, MSc Student

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Tony Szturm, PT,PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Geri Brousseau, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 11, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2013-12

Locations

CA (1)