Status:

RECRUITING

A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults

Lead Sponsor:

The Hong Kong Polytechnic University

Conditions:

Frailty at Older Adults

Mild Cognitive Impairment

Eligibility:

All Genders

60-90 years

Phase:

NA

Brief Summary

The goal of this clinical trial is to explore the effects of intermittent theta burst stimulation (iTBS) primed with theta burst stimulation (cTBS), on top of aerobic exercise, on cognitive function, ...

Detailed Description

Objectives: To compare the effects of intermittent theta burst stimulation (iTBS) primed with continuous theta burst stimulation (cTBS), nonpriming iTBS, and sham stimulation on top of aerobic exercis...

Eligibility Criteria

Inclusion Criteria:

  1. be between 60 and 90 years old;
  2. scored < 9/12 on the SPPB;
  3. scored >18/30 on the MoCA;
  4. scored >9/42 on the PFFS;
  5. lived in the community;
  6. be able to ambulate up to four meters with or without assistive devices;
  7. be able to provide written informed consent on their own behalf;
  8. can understand verbal and written Cantonese and/or English.

Exclusion Criteria:

  1. have magnetic resonance imaging (MRI) contraindications;
  2. have aerobic exercise contraindications;
  3. have transcranial magnetic stimulation contraindications;
  4. be diagnosed with neurodegenerative conditions (i.e., dementia, Parkinson's, Alzheimer's disease, Amyotrophic lateral sclerosis, and stroke);
  5. live in a nursing home or other care facilities/institutions;
  6. bed taking fixed dose of medication or had been taking medications known to potentially affect cognitive and physical function (e.g., psychotropic medications), as identified through a review of their medication lists recorded in the health software. Medications were categorized by properties (e.g., antipsychotics, antidepressants, etc.) to inform eligibility decisions.
  7. have a history indicative of carotid sinus sensitivity (i.e., falls due to loss of consciousness);
  8. cancer and undergo radiation therapy.

Key Trial Info

Start Date :

January 5 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2027

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT07497334

Start Date

January 5 2025

End Date

June 30 2027

Last Update

March 27 2026

Active Locations (1)

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The Hong Kong Polytechnic University, Department of Rehabilitation Sciences

Hong Kong, Hong Kong

A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults | DecenTrialz