Low Systemic/High Local Exercise Load in Peds SCD

Summary

This research study wants to learn about what kind of exercise is best for kids with sickle cell disease. Participating children will have a small amount of blood drawn one time at the beginning of the study. Children will then complete some questionnaires that measure pain, physical function, and emotions (depression, anxiety) and complete some tests that measure physical fitness at the beginning and end of the study. Children will be randomized to either a home-based telehealth (1) walking or (2) strengthening exercise program that lasts for 8-weeks, 3-x week, for 45 minutes each session. Children's participation will last up to 10 weeks.

Conditions

• Sickle Cell Anemia in Children

Interventions

BEHAVIORAL

Low systemic strength training

Low systemic strength training. Youth will complete exercise training for 45 minutes. Eight specific exercises will be performed to target all major muscle groups: calf raises, handgrip, squats, seated row, chest press, plank, low bac extension, and crunches (Table 1). Each exercise involves contractions with moderate load but with an extended duration of up to five minutes.16,17 During each exercise session, youth will have a 5-minute warm up, 5-minute cool down, and be allowed to take rest breaks as needed (minimum 30 seconds). Youth will initially progress by decreasing the number of rest periods and then increasing load. Youth will be provided a 2 lb medicine ball, resistance weight bands, Thera Putty, and a Yoga mat for home exercises. Youth will keep this home exercise equipment.

BEHAVIORAL

Moderate systemic exercise

Youth assigned to the moderate systemic exercise load group will perform whole-body aerobic exercise at 40-59% of heart rate reserve (HRR) for 45 minutes.76,111 Youth will complete moderate systemic aerobic exercise by walking at a brisk pace and swinging their arms as they walk. Exercise personnel will supervise a 5-minute warm up and 5-minute cool down via videoconferencing and remain on the phone with youth at all times during the walking exercise session. Youth will exercise until the prescribed duration is achieved or until fatigue at which point they will either reduce the intensity or stop until they recover. All training intensities will be based around HRR so it is individualized (not exceeding 59% of HRR). Youth unable to meet the initial training requirements will be slowly progressed over the 8 weeks.

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• University of Mississippi Medical Center

  lead OTHER

Principal Investigators

• Yolanda Griffin · Director-Clinical Trials Office

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

12 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-19

Primary Completion

2025-06-30

Completion

2025-06-30

Countries

• United States

Study Locations