Targeted exercise for African-Americans with multiple sclerosis: Project TEAAMS.
Contemp Clin Trials
; 126: 107088, 2023 03.
Article
en En
| MEDLINE
| ID: mdl-36669728
ABSTRACT
BACKGROUND:
We propose a randomized controlled trial (RCT) that examines the effects of a remotely-delivered, cultrally-tailored exercise training program for immediate and sustained improvements in patient-reported outcomes (PROs) of walking dysfunction, symptoms, and health-related quality of life (HRQOL) among African-Americans with multiple sclerosis (MS). METHODS/DESIGN:
The study will be conducted using a parallel group RCT design. The RCT examines the effects of a remotely-delivered, culturally-tailored exercise training program compared with an active control condition among 100 African-Americans with MS. The primary PROs focus on walking dysfunction. The secondary PROs include symptoms of fatigue, depression, anxiety, and HRQOL. The tertiary PROs include exercise behavior and mediator variables based on social cognitive theory. Participants will be randomly assigned into one of two conditions, intervention (Aerobic and Resistance Exercise Training) or active control (Stretching and Flexibility), using a random numbers sequence with concealed allocation. The conditions will be administered over four months by a trained behavioral coach who will be uninvolved in recruitment, screening, random assignment, and outcome assessment. We will monitor the outcomes of interest before and after the 4-month intervention period, and then again 4 months after intervention cessation for capturing stability of intervention effects. The data analysis will follow intent-to-treat principles with a linear mixed model.DISCUSSION:
If successful, this RCT will provide initial evidence for the uptake and implementation of the program in clinics/environments providing healthcare for African-Americans with MS.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Terapia por Ejercicio
/
Entrenamiento de Fuerza
/
Esclerosis Múltiple
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Aspecto:
Patient_preference
Límite:
Humans
Idioma:
En
Revista:
Contemp Clin Trials
Asunto de la revista:
MEDICINA
/
TERAPEUTICA
Año:
2023
Tipo del documento:
Article