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

Sedentary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583578
• Other study ID #: IRB202201802
• Secondary ID: P30AG028740
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: July 2023
• Source: University of Florida
• Contact: Clayton Swanson
• Phone: 352-376-7677
• Email: clayton.swanson[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight or Obese
• Sedentary

Intervention

Device:
• Home-based mobility testing and active tDCS
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
• Sham tDCS
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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking speed change from baseline	Change in the fastest safe walking speed during a two minute walk test	Measured at follow up visit (approximately three weeks after baseline)
Secondary	Timed up and go completion time from baseline	Change in the time to complete a 7 meter timed up and go	Measured at follow up visit (approximately three weeks after baseline)