Clinical trial NCT05090774: Integrating Fall Prevention Balance Exercises Into a Program for Older Adults With Peripheral Artery Disease (PAD): A Mixed Methods Feasibility Study
Official title: Integrating Fall Prevention Balance Exercises Into a Program for Older Adults With Peripheral Artery Disease (PAD): A Mixed Methods Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Fall Injury
Peripheral Artery Disease
Peripheral Arterial Disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Falls are a growing public health concern as the proportion of aging adults will continue to increase in the coming years and the prevalence of falls is high. Older adults with PAD have previously demonstrated impaired static balance, higher prevalence of history of stumbling/unsteadiness (41%) and falling (26%), and abnormal balance using computerized dynamic posturography compared to non-PAD controls. Adults with symptomatic PAD also demonstrate LE weakness and gait deficiencies due to impaired muscle power and biomechanics. While still unspecified, muscle weakness and ischemic neuropathy could partially explain the etiology for impaired balance in those with PAD. Other potential associations with increased fall risk in PAD may include claudication, limited physical activity, and poor LE function. Through expansion of disease-specific knowledge related to fall prevention interventions in older adults with PAD, healthcare providers may find that targeted balance screening and interventions to improve balance and strength are essential to disease management and the prevention of disability. The proposed study is innovative as it is the first balance intervention study in PAD and uses an explanatory sequential mixed methods design. Given the known associations between PAD and balance, in addition to morbidity and mortality associated with falls in the general population of older adults, the contribution of this knowledge is unique in that it will improve understanding of interventional study designs, leading to future revisions in prevention strategies for this sub-group.

Findings from a recent systematic review of fall prevention interventions for community-dwelling older adults with chronic conditions suggest that the stage of intervention development primarily lies within efficacy-based RCTs that focus on internal validity, which limits the generalizability of these intervention effects for varying contexts. Most of these interventional studies did not report detail related to adoption and maintenance, such as recruitment of participants from the target populations and intervention adoption by staff, which are critical to understanding how to implement these interventions in clinical settings. There was also a lack of qualitative research methods use across the studies, which limits the understanding of participants' acceptability and perceived intervention effects. Most of these trials were conducted in controlled research setting environments adjacent to, but not integrated within, clinical practice settings without staff involvement, which impacts the adoption of these programs. While all of the studies in the review included targeted, individuals, and moderately challenging balance exercises (some with additional strength and aerobic training components), the dosing of balance exercises was not sufficient to meet the exercise duration recommendations over the intervention period. Due to the stage of development, it is challenging to evaluate the long-term implementation and public impact of these interventions with delivery performed by clinicians and community partners who have direct contact with this target population. Despite the inextricable relationships between fall risk and PAD, self- management interventions for fall risk and PAD are currently not integrated into PAD treatment. Often, interventions for self-management of chronic conditions and fall prevention are delivered separately. Given the complexity, time, and effort required for PAD self-management programs, a separate stand- alone program for fall prevention exercises is unlikely due to its added burden on patients. Thus, there is a need to explore the feasibility of integrating evidence- based fall prevention exercises into existing PAD programs. Some researchers have investigated the integration of rehabilitation programs and fall prevention in patients with chronic obstructive pulmonary disease, where balance exercises were delivered as part of either outpatient and inpatient pulmonary rehab. Although balance training has not been implemented as a standard treatment for PAD subgroups, there is potential for its addition to established PAD programs. Many older adults with PAD participate in outpatient supervised exercise therapy (SET) walking programs, which are the most effective non-invasive method to mitigate claudication and improve walking function in adults with PAD. In addition to mitigating fall risk, the combined balance training within SET programs also has potential to improve patient outcomes. Balance training could be an adjunct to the SET standard of care, which is designed to improve claudication symptoms and address walking function. Although intermittent treadmill walking is the optimal mode to maximize benefits from exercise training for PAD, it is often contraindicated or refused due to poor balance. As walking demands adequate balance, LE strength, and endurance, individuals with poor postural control may benefit from improving their balance prior to or during the initiation of walking exercise to manage their vascular disease. Thus, the simultaneous learning and mastering of balance exercises to reduce fall risk may enable successful participation in treadmill walking, thus maximizing the benefits gained from SET.

Eligibility 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

Primary outcomes:
measure: Change in Mini-Balance Evaluation Systems Test Score
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Percent Target Recruitment
timeFrame: Baseline and 8 weeks
measure: Rate of Participants Enrolled Per Month
timeFrame: 8 weeks
measure: Percent of Participants that Complete 8-Week Intervention
timeFrame: 8 weeks
measure: Satisfaction Questionnaire Score
timeFrame: 8 weeks
measure: Interventions Attended
timeFrame: 8 weeks
measure: Adherence to Home-Based Balance Exercises
timeFrame: 8 weeks
measure: Change in Timed Up and Go (TUG) Test Score
timeFrame: Baseline and 8 weeks
measure: Change in Short Performance Physical Battery (SPPB) Score
timeFrame: Baseline and 8 weeks
measure: Fall Rates Per Month
timeFrame: 8 weeks
measure: Change in Falls Efficacy Scale-International Score
timeFrame: Baseline and 8 weeks
measure: Change in Life-Space Assessment (LSA) Score
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota School of Nursing
name: Siobhan K McMahon, PhD
role: PRINCIPAL_INVESTIGATOR
References: