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

NCT05090774 | Completed

• 1 other identifier: SON-2021-30171
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall; Fall Injury; Peripheral Artery Disease; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Change in Mini-Balance Evaluation Systems Test Score

  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.

  Baseline and 8 weeks

Secondary Outcomes (11)

• Percent Target Recruitment

  Baseline and 8 weeks

• Rate of Participants Enrolled Per Month

  8 weeks

• Percent of Participants that Complete 8-Week Intervention

  8 weeks

• Satisfaction Questionnaire Score

  8 weeks

• Interventions Attended

  8 weeks

Study Arms (2)

Supervised Exercise Therapy (SET) Plus Balance Exercises

EXPERIMENTAL

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)

Supervised Exercise Therapy (SET) Only

NO INTERVENTION

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).

Interventions

Adapted Otago Exercise Program (OEP) BEHAVIORAL

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).

Supervised Exercise Therapy (SET) Plus Balance Exercises

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Siobhan K McMahon, PhD

  University of Minnesota School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 25, 2021
• Study Start: October 7, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)