"Can A Prescribed Walking Program With or Without Monitoring Impact Dizziness in the Older Adults?"

NCT03403400 | Completed Results

• 1 other identifier: 1038487
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

Dizziness is a common complaint reported by 30% of people above 65 years of age and by more than 50% of those 90 years of age and older.(1) Age-related decline in vestibular, musculoskeletal, and neurologic performances compounded by a vestibular pathology can result to debilitating physical and psychological consequences. Dizziness is associated with falls,(2) disability (3) and physical inactivity.(4) Walking for endurance is cited as one of the components of vestibular rehabilitation (VR) in the "Clinical Practice Guideline for Peripheral Vestibular Hypofunction".(5) Although walking can offset the avoidance of physical activity from symptom provocation, no direct evidence has been found to support the effect of walking on postural and dynamic stability, function, and participation in people with dizziness. The primary purpose of this study is to evaluate the impact of walking as an exercise component of VR on both primary and secondary vestibular-specific outcome measures. The primary outcomes are mCTSIB, TUG test, DGI, and DHI, while the secondary outcomes are the total number of visits and length of interventions (in weeks). The second purpose is to evaluate whether pedometers increase the adherence of older adults with vestibular issues to a walking program. This will be measured by change in physical activity, as represented by International Physical Activity Questionnaire (IPAQ) Walking Metabolic Equivalent of Task (MET)-minutes/week and IPAQ Total Physical Activity MET-minutes/week scores from the IPAQ short form during the episode of care (admission and discharge) and on four-weeks follow-up compared to those patients who only received instructions to walk without a pedometer. The third purpose of this study is to establish test-retest reliability of the TUG test on older adults with dizziness. Lastly, the fourth purpose of this study to investigate if the TUG, DGI, and mCTSIB are significant and strong predictors of the DHI in older adults with dizziness. Protocol #1365169 "Predictors of Disability in the Older Adults" is being performed to supplement the number of subjects for the fourth objective of this study.

Conditions

Dizziness

Outcome Measures

Primary Outcomes (4)

• Modified Clinical Test of Sensory Integration for Balance (mCTSIB)

  The mCTSIB quantifies the ability of the patient to use information from somatosensory, visual and vestibular system effectively for postural stability. This test eliminated conditions 3 and 6 of the original CTSIB, which use an altered visual input (visual conflict dome). It is performed with the feet together, a modification from the original test, which is with feet apart.(7) The four conditions of mCTSIB are standing on firm surface eyes open, standing on firm surface eyes closed, standing on compliant surface eyes open, and standing on compliant surface eyes closed. The patient is timed for 30 seconds and the average score of three trials is obtained. It only requires a timer and balance foam to administer the test.

  Change from up to week 9 of treatment to up to 16 weeks of treatment

• Timed Up and Go (TUG) Test

  The TUG is a test of balance and risk for falls.(8) This test measures the time it takes to walk 3 meters starting from a sitting position and it ends when the patient is seated again. Among the population studied for the TUG are the frail elderly and vestibular disorders.(9) The cut-off scores that indicate risk for falls are greater than 13.5 seconds for community dwelling older adults (8) and greater than 11.1 seconds for vestibular disorders.(10)

  Change from up to week 9 of treatment to up to 16 weeks of treatment

• Dynamic Gait Index

  The DGI assesses the ability to maintain balance while walking in the presence of external demands. It is scored based on a 4-point ordinal scale (3=no gait dysfunction, 2=minimal impairment, 1=moderate impairment and 0=severe impairment) with the highest possible score of 24.(11) A cut-off score of less than 19 is indicative of increased fall risks in community-dwelling elderlies.(12)

  Change from up to week 9 of treatment to up to 16 weeks of treatment

• Dizziness Handicap Inventory (DHI)

  The DHI is a 25-item self-report questionnaire that quantifies the functional, emotional and physical impact of dizziness. Answers are graded 0 for no, 2 for sometimes and 4 for yes, with a maximum total score of 100. Interpretations are mild dizziness for scores between 0-30, moderate for 31-60 and severe for 61-100.(13)

  Change from up to week 9 of treatment to up to 16 weeks of treatment

Secondary Outcomes (2)

• Total Number of Visits

  From initial evaluation (day 1 of treatment) to up to 16 weeks of treatment

• Length of Interventions in Weeks

  From initial evaluation (day 1 of treatment) to up to 16 weeks of treatment

Other Outcomes (1)

• International Physical Activity Questionnaire (IPAQ)- Walk

  Change from up to week 9 of treatment to up to 4 weeks post treatment

Study Arms (3)

VRWP Group

EXPERIMENTAL

Vestibular Rehabilitation plus Walking with Pedometer Groupd

Behavioral: VRWP Group

VRW Group

ACTIVE COMPARATOR

Vestibular Rehabilitation plus Walking without Pedometer Group

Behavioral: VRW Group

VR Group

NO INTERVENTION

Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.

Interventions

VRWP Group BEHAVIORAL

The VRWP group will have VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group). They will receive pedometers (Fitbit Zip), instructions on how to use the pedometer, step log forms, with home instruction handout to walk more at least more than ten minutes at a time. The participants will record on their activity log the number of steps shown on the step display at the end of the day. The daily step log form will be given to the research staff every visit for recording. The research staff will encourage their participants to increase their daily steps at least 10% until they achieve at least 3,000 steps daily.

VRWP Group

VRW Group BEHAVIORAL

The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.

VRW Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older referred for physical therapy evaluation for symptoms of dizziness, postural instability, or both
• Able to walk without the physical help of another person, with or with no assistive device
• Able to follow commands and execute the examination and intervention instructions in the English language
• Willing to participate in a phone interview four weeks after discharge
• Able to provide informed consent

You may not qualify if:

• Unstable medical issues, such as unstable or uncontrolled cardiovascular conditions, elevated blood pressure (Systolic greater than or equal to 140mmHg and diastolic greater than or equal to 90mmHg), orthostatic hypotension (a fall in systolic blood pressure of at least 20mmHg or diastolic blood pressure of at least 10mmHg when a person stands from a sitting or lying down position), uncontrolled metabolic disease, as determined by the evaluating physical therapist, documented in the Functional Comorbidity Index, vital signs and assessment portion of the initial evaluation.
• History of falls from syncopal origin
• Dizziness of central origin, such as stroke, head injuries, MS or PD;
• Active BPPV (patients with positive dix hallpike and/or roll test)
• Inability to walk without physical assistance.

Sponsors & Collaborators

• AdventHealth: lead
• Adventist University: collaborator

Study Sites (2)

Florida Hospital East Orlando

Orlando, Florida, 32822, United States

Location

Florida Hospital Winter Park

Winter Park, Florida, 32792, United States

Location

Related Publications (14)

• Maarsingh OR, Stam H, van de Ven PM, van Schoor NM, Ridd MJ, van der Wouden JC. Predictors of dizziness in older persons: a 10-year prospective cohort study in the community. BMC Geriatr. 2014 Dec 15;14:133. doi: 10.1186/1471-2318-14-133.

  PMID: 25510936 BACKGROUND

• Liston MB, Bamiou DE, Martin F, Hopper A, Koohi N, Luxon L, Pavlou M. Peripheral vestibular dysfunction is prevalent in older adults experiencing multiple non-syncopal falls versus age-matched non-fallers: a pilot study. Age Ageing. 2014 Jan;43(1):38-43. doi: 10.1093/ageing/aft129. Epub 2013 Sep 15.

  PMID: 24042003 BACKGROUND

• Mueller M, Strobl R, Jahn K, Linkohr B, Ladwig KH, Mielck A, Grill E. Impact of vertigo and dizziness on self-perceived participation and autonomy in older adults: results from the KORA-Age study. Qual Life Res. 2014 Oct;23(8):2301-8. doi: 10.1007/s11136-014-0684-x. Epub 2014 Apr 10.

  PMID: 24719016 BACKGROUND

• Mueller M, Strobl R, Jahn K, Linkohr B, Peters A, Grill E. Burden of disability attributable to vertigo and dizziness in the aged: results from the KORA-Age study. Eur J Public Health. 2014 Oct;24(5):802-7. doi: 10.1093/eurpub/ckt171. Epub 2013 Nov 8.

  PMID: 24213583 BACKGROUND

• Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Evidence-Based Clinical Practice Guideline: FROM THE AMERICAN PHYSICAL THERAPY ASSOCIATION NEUROLOGY SECTION. J Neurol Phys Ther. 2016 Apr;40(2):124-55. doi: 10.1097/NPT.0000000000000120.

  PMID: 26913496 BACKGROUND

• Hall CD, Heusel-Gillig L, Tusa RJ, Herdman SJ. Efficacy of gaze stability exercises in older adults with dizziness. J Neurol Phys Ther. 2010 Jun;34(2):64-9. doi: 10.1097/NPT.0b013e3181dde6d8.

  PMID: 20588090 BACKGROUND

• Horn LB, Rice T, Stoskus JL, Lambert KH, Dannenbaum E, Scherer MR. Measurement Characteristics and Clinical Utility of the Clinical Test of Sensory Interaction on Balance (CTSIB) and Modified CTSIB in Individuals With Vestibular Dysfunction. Arch Phys Med Rehabil. 2015 Sep;96(9):1747-8. doi: 10.1016/j.apmr.2015.04.003. No abstract available.

  PMID: 26550644 BACKGROUND

• Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.

  PMID: 10960937 BACKGROUND

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

• Whitney SL, Marchetti GF, Schade A, Wrisley DM. The sensitivity and specificity of the Timed "Up & Go" and the Dynamic Gait Index for self-reported falls in persons with vestibular disorders. J Vestib Res. 2004;14(5):397-409.

  PMID: 15598995 BACKGROUND

• Wrisley DM, Walker ML, Echternach JL, Strasnick B. Reliability of the dynamic gait index in people with vestibular disorders. Arch Phys Med Rehabil. 2003 Oct;84(10):1528-33. doi: 10.1016/s0003-9993(03)00274-0.

  PMID: 14586922 BACKGROUND

• Shumway-Cook A, Baldwin M, Polissar NL, Gruber W. Predicting the probability for falls in community-dwelling older adults. Phys Ther. 1997 Aug;77(8):812-9. doi: 10.1093/ptj/77.8.812.

  PMID: 9256869 BACKGROUND

• Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.

  PMID: 2317323 BACKGROUND

• Shook RP, Gribben NC, Hand GA, Paluch AE, Welk GJ, Jakicic JM, Hutto B, Burgess S, Blair SN. Subjective Estimation of Physical Activity Using the International Physical Activity Questionnaire Varies by Fitness Level. J Phys Act Health. 2016 Jan;13(1):79-86. doi: 10.1123/jpah.2014-0543. Epub 2015 Apr 21.

  PMID: 25898394 BACKGROUND

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size, lack of blinding, lack of intention-to-treat, lack of objective measures for physical activity, unequal distribution of subjects based on DHI severity score, retrospective data collection for predictors of DHI

Results Point of Contact

• Title: Amie Jasper
• Organization: Advent Health

amiemarie.jasper@adventhealth.com

407-303-8626

Study Officials

• Mary Blackinton, EED

  Nova Southeastern University

  STUDY DIRECTOR

• Joann Gallichio, DSC

  Nova Southeastern University

  STUDY DIRECTOR

• Ann Galgon, PhD

  University of the Sciences

  STUDY DIRECTOR

• Leana Araujo, PhD

  Adventist University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental Design. To answer the study objective, a pragmatic, randomized, prospective, clinical study on 54 older adults with dizziness will be utilized. This will be conducted at Florida Hospital Sports Medicine and Rehabilitation locations that offer vestibular therapy. These are in East Orlando and Winter Park.

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 18, 2018
• Study Start: July 18, 2018
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: July 2, 2020
• Results First Posted: July 2, 2020

Record last verified: 2020-06

Locations

US (2)