Recruiting

Exercise Load

Sponsor:

University of Mississippi Medical Center

Code:

NCT06387758

Conditions

Sickle Cell Anemia in Children

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

Interventions

Low systemic strength training

Moderate systemic exercise

Study Details

Brief 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

Study ID

NCT06387758

Start date

Sep 19, 2023

Status verified date

Apr, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

  • youth 12 to 17 years old
  • diagnosed with SCD genotype SS, SC, beta-plus thalassemia, or beta-zero thalassemia
  • has daily access to an Internet enabled device (e.g., smart phone, IPad) A parent (≥21 years old) will also be recruited for each youth participant.

Exclusion Criteria:

  • non-English speaking due to lack of available written translation services for informed consent and questionnaires
  • cognitive impairment (e.g., moderate to profound intellectual disability) that precludes study completion
  • medical condition (e.g., hypertension, bone fracture) that precludes completing exercise safely (determined by study medical director Dr. McNaull).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low systemic strength training

8-week (3 times per week; 45-minute sessions) home-based telehealth strengthening exercise program

experimental: Moderate systemic exercise

8-week (3 times per week; 45-minute sessions) home-based telehealth walking protocol

Interventions

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.

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.

Primary outcome measure

  • Demographics and medical history (parents) [ Time Frame: through study completion, an avg. of 10 weeks ]
  • Pediatric Pain Questionnaire [ Time Frame: through study completion, an avg. of 10 weeks ]
  • Functional Disability Inventory [ Time Frame: through study completion, an avg. of 10 weeks ]
  • NIH PROMIS 2582 [ Time Frame: through study completion, an avg. of 10 weeks ]
  • Heart Rate Variability [ Time Frame: through study completion, an avg. of 10 weeks ]
  • Heart Rate [ Time Frame: through study completion, an avg. of 10 weeks ]
  • Blood Pressure [ Time Frame: through study completion, an avg. of 10 weeks ]
  • Bruininks-Oseretsky Test of Motor Proficiency [ Time Frame: through study completion, an avg. of 10 weeks ]
  • American Thoracic Society 6-minute walk test [ Time Frame: through study completion, an avg. of 10 weeks ]
  • Actigraphy [ Time Frame: through study completion, an avg. of 10 weeks ]
  • Daily diaries [ Time Frame: through study completion, an avg. of 10 weeks ]
  • Biomarkers [ Time Frame: pre- 2 weeks ]
  • Medical Chart Review [ Time Frame: pre- 2 weeks ]

Central Contacts and Locations

Central contacts

Cynthia W Karlson, PhD

6019842723ckarlson@umc.edu

Rhonda Aikens

601-984-2716raikens@umc.edu

Locations

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Cynthia Karlson, PhD

601-984-2723ckarlson@umc.edu

More Information

Sponsor

University of Mississippi Medical Center

Last update posted

Apr 29, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Mississippi Medical Center on 2024-04-29.