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HOMEStudy: Development of a Home-based Self-delivered Prehabilitation Intervention to Proactively Reduce Fall Risk in Older Adults

Primary Purpose

Sedentary, Overweight or Obese

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based mobility testing and active tDCS
Sham tDCS
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sedentary

Eligibility Criteria

70 Years - 95 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 70 - 95 years of age
  • Self-report having a risk of falling. Fall risk will be determined by asking whether the participant has had (and recovered from) a fall related injury in the previous year or had fallen two or more times in the previous year or if the participant is afraid of falling because of their balance or walking. (This criterion is based on the 2020 NEJM study: "A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries")
  • Self-report of "some difficulty with walking tasks, such as becoming tired when walking a quarter mile, or when climbing two flights of stairs, or when performing household chores."
  • Willingness to be randomized to either study group and to participate in all aspects of the study assessment and intervention.
  • Living in the community and able to travel to the research site.
  • Ability to independently assemble and put on the tDCS headband or incorporate the involvement of a willing study partner (e.g., a spouse, family member, or friend) who agrees to assist with this task during each home intervention session.
  • Access to an internet-connected computer or television capable of playing videos with sound located in a quiet area with a comfortable stationary chair.
  • Able to provide informed consent.

Exclusion Criteria:

  • Diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition (spinal cord injury, Alzheimer's, Parkinson's, stroke, etc.)
  • A score of 23 or lower on the Montreal Cognitive Assessment (MoCA)
  • Contraindications to non-invasive brain stimulation (e.g., metal in head, wound on scalp)
  • Use of medications affecting the central nervous system including, but not limited to, benzodiazepines, anti-cholinergic medications, and GABAergic medications.
  • Severe arthritis, such as awaiting joint replacement
  • Current cardiovascular, lung or renal disease; diabetes; terminal illness
  • Myocardial infarction or major heart surgery in the previous year
  • Cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis (e.g., early-stage breast or prostate cancer)
  • Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
  • Difficulty communicating with study personnel (including people who cannot speak English)
  • Uncontrolled hypertension at rest (systolic > 180 mmHg and/or diastolic > 100 mmHg)
  • Bone fracture or joint replacement in the previous six months
  • Current participation in physical therapy for lower extremity function or cardiopulmonary rehabilitation
  • Current enrollment in any clinical trial
  • Clinical judgment of investigative team

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

Outcomes

Primary Outcome Measures

Walking speed change from baseline
Change in the fastest safe walking speed during a two minute walk test

Secondary Outcome Measures

Timed up and go completion time from baseline
Change in the time to complete a 7 meter timed up and go

Full Information

First Posted
October 13, 2022
Last Updated
July 5, 2023
Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05583578
Brief Title
HOMEStudy: Development of a Home-based Self-delivered Prehabilitation Intervention to Proactively Reduce Fall Risk in Older Adults
Official Title
Development of a Home-based Self-delivered Prehabilitation Intervention to Proactively Reduce Fall Risk in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Older adults often have difficulty performing complex walking tasks leading to increased fall incidence and subsequent injury. Even in the best clinical settings, it may not be possible for patients or clinicians to dedicate the time and financial resources needed to enact lasting improvements. The study will investigate the use of non-invasive brain stimulation and motor imagery practice within participants homes to assess study design feasibility and potential for mobility improvement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary, Overweight or Obese

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Home-based mobility testing and active tDCS
Intervention Description
A Soterix Clinical Trials tDCS unit will be used for delivery of stimulation for twenty minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm2 sponges placed over the frontal cortices at F3 and F4 (based on the international "10-20 system" of standardized brain electrode placement). 2.0mA was
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2.0mA of direct current stimulation at the beginning of each rehabilitation session. Since participants habituate to the sensation of tDCS within 30-60 seconds of stimulation, this procedure provides the same sensation of active tDCS.
Primary Outcome Measure Information:
Title
Walking speed change from baseline
Description
Change in the fastest safe walking speed during a two minute walk test
Time Frame
Measured at follow up visit (approximately three weeks after baseline)
Secondary Outcome Measure Information:
Title
Timed up and go completion time from baseline
Description
Change in the time to complete a 7 meter timed up and go
Time Frame
Measured at follow up visit (approximately three weeks after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 70 - 95 years of age Self-report having a risk of falling. Fall risk will be determined by asking whether the participant has had (and recovered from) a fall related injury in the previous year or had fallen two or more times in the previous year or if the participant is afraid of falling because of their balance or walking. (This criterion is based on the 2020 NEJM study: "A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries") Self-report of "some difficulty with walking tasks, such as becoming tired when walking a quarter mile, or when climbing two flights of stairs, or when performing household chores." Willingness to be randomized to either study group and to participate in all aspects of the study assessment and intervention. Living in the community and able to travel to the research site. Ability to independently assemble and put on the tDCS headband or incorporate the involvement of a willing study partner (e.g., a spouse, family member, or friend) who agrees to assist with this task during each home intervention session. Access to an internet-connected computer or television capable of playing videos with sound located in a quiet area with a comfortable stationary chair. Able to provide informed consent. Exclusion Criteria: Diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition (spinal cord injury, Alzheimer's, Parkinson's, stroke, etc.) A score of 23 or lower on the Montreal Cognitive Assessment (MoCA) Contraindications to non-invasive brain stimulation (e.g., metal in head, wound on scalp) Use of medications affecting the central nervous system including, but not limited to, benzodiazepines, anti-cholinergic medications, and GABAergic medications. Severe arthritis, such as awaiting joint replacement Current cardiovascular, lung or renal disease; diabetes; terminal illness Myocardial infarction or major heart surgery in the previous year Cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis (e.g., early-stage breast or prostate cancer) Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder Difficulty communicating with study personnel (including people who cannot speak English) Uncontrolled hypertension at rest (systolic > 180 mmHg and/or diastolic > 100 mmHg) Bone fracture or joint replacement in the previous six months Current participation in physical therapy for lower extremity function or cardiopulmonary rehabilitation Current enrollment in any clinical trial Clinical judgment of investigative team
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clayton Swanson
Phone
352-376-7677
Email
clayton.swanson@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clayton Swanson
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clayton Swason, PhD
Email
clayton.swanson@ufl.edu
First Name & Middle Initial & Last Name & Degree
Clayton Swanson, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

HOMEStudy: Development of a Home-based Self-delivered Prehabilitation Intervention to Proactively Reduce Fall Risk in Older Adults

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