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Merging Attentional Focus and Balance Training to Reduce Fall Risk in Older Adults

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ClinicalTrials.gov Identifier: NCT03776201
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : December 14, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of North Carolina, Greensboro

Brief Summary:
Approximately 15 million older adults fall every year in the United States and fall prevention programs have only been moderately successful in arresting fall rates. This proposal uses motor learning principles derived from the attentional focus literature to determine whether training someone where to focus their attention during a balance task enhances balance control and reduces fall risk. Older adults (N=90) who are classified as fallers (one or more falls in the past 12 months) will be recruited. A series of balance control, clinical metrics of fall risk, and patient-reported outcomes will be assessed prior, during, and after a 12-week intervention to examine changes in performance and fall risk. The 12-week intervention will emphasize directing the participants' attention either internally or externally during a series of balance tasks. Empirical evidence and our preliminary data leads us to hypothesize that an external focus of attention training will positively influence balance control. This will be the first study to will examine balance control changes over 12-week balance intervention using an attentional focus paradigm and we will relate the balance control changes to clinical metrics that indicate fall risk and patient-reported outcomes. Further, our proposal includes a novel model of entropy in postural sway, a metric that has been proposed to relate to balance ability, to help explain the hypothesized enhancement in balance. Thus, this proposal will merge motor learning principles with a 12-week balance intervention to determine if fall risk is reduced in older adults. Specific Aim 1 compares balance performance within each trial/session throughout the 12 weeks of balance training to evaluate whether the attentional focus groups (external vs. internal) differ in their motor learning trajectory with respect to the balance task. Specific Aim 2 compares the motor ability outcome measures that relate to fall-risk between the groups (external focus, internal focus, or control) before, during, and after the 12-week balance intervention. Specific Aim 3 compares the patient-reported outcome measures of fear of falling, functional health and well-being, and fear of injury from movement between the groups (external focus, internal focus, or control) before, during, and after the 12-week balance intervention.

Condition or disease Intervention/treatment Phase
Accidental Fall Other: Balance Training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Merging Attentional Focus and Balance Training to Reduce Fall Risk in Older Adults
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Experimental: Internal Focus
The internal focus group will receive 20 minutes of balance training 2 times per week. All training sessions will include a 5-minute walking warm-up, a 20-minute balance training program, and a 5-minute walking cool-down. The balance training will use a 30" wobble board with five bases ranging from 1" (easy) to 3" (very difficult). 20 trials of balance practice for 30-second intervals with 30-second breaks in between trials will be used every day. The Internal Focus group will be reminded to focus their attention internally via the prompt "keep your feet as level as possible" prior to each balance trial. To monitor whether the experimental groups are focusing as asked and to what extent, a compliance check that has been used in similar attentional focus literature will be used.
Other: Balance Training
We expect that a balance training intervention that utilizes an external focus of attention will lead to the adoption of balance strategies that are protective against falls. The mechanism for this behavioral change will be identified using a Dynamical Systems Theory framework (i.e., entropy) to quantify postural sway characteristics before, during and after the training. We will determine whether the balance intervention utilizing an external focus of attention will lead to positive benefits through the three specific aims.

Experimental: External Focus
The external focus group will receive 20 minutes of balance training 2 times per week. All training sessions will include a 5-minute walking warm-up, a 20-minute balance training program, and a 5-minute walking cool-down. The balance training will use a 30" wobble board with five bases ranging from 1" (easy) to 3" (very difficult). 20 trials of balance practice for 30-second intervals with 30-second breaks in between trials will be used every day. The external focus group will be reminded to focus their attention externally via the prompt "please keep the board as level as possible" prior to each balance trial. To monitor whether the experimental groups are focusing as asked and to what extent, a compliance check that has been used in similar attentional focus literature will be used.
Other: Balance Training
We expect that a balance training intervention that utilizes an external focus of attention will lead to the adoption of balance strategies that are protective against falls. The mechanism for this behavioral change will be identified using a Dynamical Systems Theory framework (i.e., entropy) to quantify postural sway characteristics before, during and after the training. We will determine whether the balance intervention utilizing an external focus of attention will lead to positive benefits through the three specific aims.

No Intervention: Control
The control group will not receive any balance training



Primary Outcome Measures :
  1. Change in the BTracks measurement [ Time Frame: Weeks 0, 6, 12, 13, 16, 20 ]
    The average measurement of the center of pressure displacement during three 20-second trials with eyes closed

  2. Change in the Functional Gait Assessment [ Time Frame: Weeks 0, 6, 12, 13, 16, 20 ]
    Assesses postural stability during walking tasks

  3. Change in the Timed Up and Go [ Time Frame: Weeks 0, 6, 12, 13, 16, 20 ]
    Assesses a person's mobility and requires both static and dynamic balance.

  4. Change in the Berg Balance Test [ Time Frame: Weeks 0, 6, 12, 13, 16, 20 ]
    Assesses the static standing balance and subsequent fall risk

  5. Change in the Activities Balance Confidence Scale short version [ Time Frame: Weeks 0, 6, 12, 13, 16, 20 ]
    Assesses the Fear of Falling. The scale is from 0-100% for the overall scores. The scores from each of the 16 questions (which range from 0-100%) are summed and then divided by 16 to get the overall score. A high score equates to greater function.

  6. Change in the Short Form 36 [ Time Frame: Weeks 0, 6, 12, 13, 16, 20 ]
    The SF-36 is a measure of health status. Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.

  7. Change in the Tampa Scale of Kinesiophobia [ Time Frame: Weeks 0, 6, 12, 13, 16, 20 ]
    The Tampa Scale of Kinesiophobia measures the fear of injury from movement on a range of 17-68, with high scores indicating high fear of movement related injury. A cutoff score of 37 indicates increased fear of injury from movement


Secondary Outcome Measures :
  1. Change in the XSens - Time in Balance - Anterior Posterior [ Time Frame: Assessed at the end of each training session, which is provided 2 times per week for 12 weeks. Thus, this variable is assessed a total of 24 times. After the 24 sessions, the timeframe is complete for this outcome. ]
    Duration in which the wobble board is +/- 3 deg of a neutral position (0 deg) in the anterior-posterior direction for 30 seconds

  2. Change in the XSens - Time in Balance - Medial Lateral [ Time Frame: Assessed at the end of each training session, which is provided 2 times per week for 12 weeks. Thus, this variable is assessed a total of 24 times. After the 24 sessions, the timeframe is complete for this outcome. ]
    Duration in which the wobble board is +/- 3 deg of a neutral position (0 deg) in the medial-lateral direction for 30 seconds

  3. Change in the XSens - Mean Power Frequency - Anterior Posterior [ Time Frame: Assessed at the end of each training session, which is provided 2 times per week for 12 weeks. Thus, this variable is assessed a total of 24 times. After the 24 sessions, the timeframe is complete for this outcome. ]
    Mean power frequency of the wobble board in the anterior-posterior direction for 30 seconds

  4. Change in the XSens - Mean Power Frequency - Medial Lateral [ Time Frame: Assessed at the end of each training session, which is provided 2 times per week for 12 weeks. Thus, this variable is assessed a total of 24 times. After the 24 sessions, the timeframe is complete for this outcome. ]
    Mean power frequency of the wobble board in the medial-lateral direction for 30 seconds



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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older adults (N=90) who are classified as fallers (≥ 1 fall in the last 12 months) will be recruited

Exclusion Criteria:

  • • Younger than 65 or older than 90 years old

    • Failure to receive medical clearance from their physician to participate in the study and confirming that their patient has fallen at least once within the last 12 months
    • Inability to walk independently for at least 10 consecutive minutes
    • Score in the "impaired" range on the Mini-Mental State Examination, adjusted for age and education level [60].
    • A diagnosis of a neurological disorder that requires medication
    • A visual impairment of 20/70 or worse
    • A body mass index of ≥ 30
    • Any acute medical problems, including musculoskeletal based impairments, that lead to pain or discomfort during standing or walking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776201


Contacts
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Contact: Littlefield, PhD 3362561298 kplittle@uncg.edu

Locations
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United States, North Carolina
Wellspring Retirement Community Recruiting
Greensboro, North Carolina, United States, 27455
Contact: Garret Saake, PhD    336-545-5451    gsaake@well-spring.org   
Principal Investigator: Louisa D Raisbeck, PhD         
Sponsors and Collaborators
University of North Carolina, Greensboro
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Louisa D Raisbeck, PhD University of North Carolina, Greensboro

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Responsible Party: University of North Carolina, Greensboro
ClinicalTrials.gov Identifier: NCT03776201     History of Changes
Other Study ID Numbers: A18-0033
1R15AG053866-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No