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Integrating Fall Prevention Balance Exercises Into a Program for Older Adults With Peripheral Artery Disease (PAD): A Mixed Methods Feasibility Study

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ClinicalTrials.gov Identifier: NCT05090774
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
The overarching objective of this study is to improve fall prevention efforts in community-dwelling older adults with peripheral artery disease (PAD) to reduce falls. To accomplish this, the investigators will conduct a feasibility study and pilot the addition of a balance exercise component to existing supervised exercise therapy (SET) programs for PAD. This intervention may be an effective way to help older adults with PAD self-manage their leg pain and walking impairments as well as fall risk. The long-term goal of this research is to reduce morbidity and mortality associated with falls in older adults with symptomatic PAD through the development and evaluation of a balance intervention component implemented within existing exercise programs. Findings from this research may also be translated to the implementation of disease management programs for other chronic conditions associated with fall risk. The rationale for this research is to determine improve disease-specific, comprehensive and fall prevention strategies for older adults with PAD.

Condition or disease Intervention/treatment Phase
Fall Fall Injury Peripheral Artery Disease Peripheral Arterial Disease Behavioral: Adapted Otago Exercise Program (OEP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Integrating Fall Prevention Balance Exercises Into a Program for Older Adults With Peripheral Artery Disease (PAD): A Mixed Methods Feasibility Study
Actual Study Start Date : October 7, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supervised Exercise Therapy (SET) Plus Balance Exercises
Intervention meetings surrounding supervised exercise therapy (SET) with the addition of the adapted Otago Exercise Program (OEP) will occur individually with participants in a 1:1 format once per week for 30 minutes over 8 weeks. Additionally, participants will be encouraged to practice exercises at home at least 2 additional days between intervention meetings using visual handouts (up to 7 times/week total, approximately 140 minutes/week).
Behavioral: Adapted Otago Exercise Program (OEP)
A modified version of the 8- week evidence-based Otago Exercise Program (OEP), adapted for integration into supervised exercise therapy (SET). The OEP exercises will include 12 static and dynamic standing balance movements (knee bends, backwards walking, walking and turning, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, heel-toe walking backwards, sit to stand, stair walking). The OEP also contains additional behavior change techniques embedded within the intervention protocol (i.e. feedback on behavior, self-monitoring of behavior, biofeedback).

No Intervention: Supervised Exercise Therapy (SET) Only
Intervention meetings surrounding supervised exercise therapy (SET) will occur individually with participants in a 1:1 format once per week for 30 minutes over 8 weeks. Additionally, participants will be encouraged to practice exercises at home at least 2 additional days between intervention meetings using visual handouts (up to 7 times/week total, approximately 140 minutes/week).



Primary Outcome Measures :
  1. Change in Mini-Balance Evaluation Systems Test Score [ Time Frame: Baseline and 8 weeks ]
    The Mini-Balance Evaluation Systems Test consists of 14 items with total scores ranging from 0-28. Higher scores indicate better balance performance. Balance will be evaluated pre- and post-intervention.


Secondary Outcome Measures :
  1. Percent Target Recruitment [ Time Frame: Baseline and 8 weeks ]
    The percent of target recruitment achieved will be assessed pre- and post-intervention as a measure of demand.

  2. Rate of Participants Enrolled Per Month [ Time Frame: 8 weeks ]
    Enrollment rates per month will be reported as participants per month as a measure of demand.

  3. Percent of Participants that Complete 8-Week Intervention [ Time Frame: 8 weeks ]
    The percent of participants that complete the 8-week intervention out of total participants will be reported as a measure of retention and acceptance.

  4. Satisfaction Questionnaire Score [ Time Frame: 8 weeks ]
    Satisfaction with and evaluation of the program will be assessed via a 5-item Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree', where higher scores indicate greater satisfaction.

  5. Interventions Attended [ Time Frame: 8 weeks ]
    Attendance will be measured as the average number of intervention sessions attended across participants and reported as a number of sessions.

  6. Adherence to Home-Based Balance Exercises [ Time Frame: 8 weeks ]
    Intervention fidelity will be measured via adherence to home-based balance exercises and reported as the average number of days that participants exercised at home per week. Adherence will be assessed weekly via an exercise tracker.

  7. Change in Timed Up and Go (TUG) Test Score [ Time Frame: Baseline and 8 weeks ]
    The TUG test measures the time it takes to stand from a chair, walk 10 feet, turn around, walk to the chair, and sit and will be reported in seconds. TUG test will be assessed pre- and post-intervention.

  8. Change in Short Performance Physical Battery (SPPB) Score [ Time Frame: Baseline and 8 weeks ]
    The SPPB is reported as a score on 5 balance, strength, and walking tests that evaluate lower extremity function. The range of summed scores is 0-12, where 12 indicates better lower extremity function. The SPPB will be assessed pre- and post-intervention.

  9. Fall Rates Per Month [ Time Frame: 8 weeks ]
    The average monthly rate of self-reported falls over the intervention period will be reported as falls per month.

  10. Change in Falls Efficacy Scale-International Score [ Time Frame: Baseline and 8 weeks ]
    The Falls Efficacy scale assesses levels of concern for falling while performing 16 different common tasks with the sum of scores ranging from 0-100, where 100 indicates [INSERT]. The Falls Efficacy Scale will be assessed pre- and post-intervention.

  11. Change in Life-Space Assessment (LSA) Score [ Time Frame: Baseline and 8 weeks ]
    The LSA is reported as the average weekly frequency and independence of life-space mobility, with a sum of scores ranging from 0-120, where higher scores indicate greater mobility. LSA will be measured pre- and post-intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in supervised exercise therapy (SET)
  • One or more fall risk factors as determined by CDC STEADI fall risk screener

    • One or more falls in the last year
    • Unsteadiness when standing or walking
    • Worries about falling
  • Have symptomatic peripheral artery disease (PAD) with objective diagnosis (ABI less than or equal to 0.90 or previous revascularization)

Exclusion Criteria:

  • Formal diagnosis of neurocognitive impairment or <3 on Callahan 6-Item Screener
  • Current uncontrolled vestibular dysfunction (e.g. Meniere's Disease, benign paroxysmal positional vertigo)
  • Participants who self-report the following symptoms will require clearance from a primary provider (as guided by the Exercise and

Screening for You Questionnaire):

  • Pain, tightness or pressure in chest during physical activity (walking, climbing stairs, household chores, similar activities) that have not been checked and/ or treated by a healthcare provider
  • Current dizziness that have not been checked and/ or treated by a healthcare provider
  • Current, frequent falls that have not been checked and/ or treated by a healthcare provider

    • Other clinically significant disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study

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): NCT05090774


Contacts
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Contact: Siobhan K McMahon, PhD (612) 625-3225 skmcmaho@umn.edu
Contact: Elizabeth A Choma, PT, DPT (509) 994-7121 choma006@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Siobhan K McMahon, PhD University of Minnesota School of Nursing
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT05090774    
Other Study ID Numbers: SON-2021-30171
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
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
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases