Home-Based Walking for Thinking Skills in Persons With TBI

Официальное название

Safety and Feasibility of Remote Walking Exercise for Cognitive Improvement in Persons With TBI

Обзор

The purpose of this research study is to investigate the effects of a home-based 3-month long walking exercise program on cognitive (thinking) performance in persons with TBI. As a participant, you will complete this 3-month exercise program now or after a 3-month wait period.

Подробное описание

This study involves no in-person visits to Kessler Foundation and takes place at home.

The first study activity will last about 1 hour in total and will involve using videoconferencing software (Zoom) to take tests of thinking (e.g., matching shapes and number, learning a list of words). You will then complete several brief questionnaires about everyday activities and TBI symptoms over the computer.

You will then be randomly picked (like the flip of a coin) by a computer to participate in one of two groups. You will have a 50/50 chance of being placed in either group.

One group will complete 3-months of walking exercise at home. The exercise program is based on activity guidelines for people with TBI and will be monitored by a trained exercise leader. You will be asked to walk 3 times per week. The first two weeks will require you to walk for 10 minutes at a time, and that duration will increase throughout the 3-months. You will have a dedicated trainer to help get started, answer questions, and support you throughout the programs. You will have regular meetings with this trainer by video conference (Zoom). You will be sent a FitBit to wear on your wrist while exercising to track your steps, and that you will be allowed to keep when the study ends.

The other group will stick to a regular routine during this 3-month period (i.e., wait-list group).

At the end of the 3-month exercise program, you will repeat the thinking tests and questionnaires. The wait-list group will be given the exercise prescription after this last Zoom session.

Вмешательства

• Поведенческое Walking
  One group will complete 3-months of walking exercise at home. The exercise program is based on activity guidelines for people with TBI and will be monitored by a trained exercise leader. You will be asked to walk 3 times per week. The first two weeks will require you to walk for 10 minutes at a time, and that duration will increase throughout the 3-months. You will have a dedicated trainer to help get started, answer questions, and support you throughout the programs. You will have regular meeti

Первичные конечные точки

• Adverse Events [Срок оценки: Through study completion, which is 3 months for intervention and 6 months for wait list.]
• Adherence [Срок оценки: Through study completion, which is 3 months for intervention and 6 months for wait list.]
• Compliance [Срок оценки: Through study completion, which is 3 months for intervention and 6 months for wait list.]

Вторичные конечные точки (3)

• Processing Speed [Срок оценки: Baseline and follow-up (12-weeks post-baseline)]
• Learning/Memory [Срок оценки: Baseline and follow-up (12-weeks post-baseline)]
• Executive function [Срок оценки: Baseline and follow-up (12-weeks post-baseline)]

Критерии участия

Критерии включения

• Definitive TBI diagnosis at least 1 year prior, verified by medical records
• Self-report problems with thinking skills since the TBI diagnosis (e.g., processing information, learning or remembering, organizing, multitasking)
• Between the ages of 18 and 65
• Access to internet and email
• Fluent in English
• Can walk at a brisk pace without using an assistive device
• Not fallen due to mobility issues from their TBI in the past 6 months
• Do not currently meet public health guidelines for physical activity
• Have problems with thinking performance

Критерии исключения

• I currently have uncontrolled major depression
• I have a history of schizophrenia, bipolar disorder I or II, or substance-abuse disorders
• I am regularly taking medications that can affect my thinking, such as antipsychotics or benzodiazepines. Study staff will review my medications to determine if I am taking any that would make me ineligible for this study
• I have known/diagnosed cardiovascular disease including uncontrolled hypertension, diabetes, or kidney disease
• I am unable to make everyday decisions on my own

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Kessler Foundation — East Hanover

Идентификаторы

NCT: NCT07733284 · E-1314-26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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