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Gerofit Exercise for Sickle Cell Disease (SICKLE-FIT Trial)
N/A
Recruiting
Led By Charity I Oyedeji, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a diagnosis of sickle cell disease (any genotype) confirmed by hemoglobin electrophoresis, high performance liquid chromatography, or genotyping
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
SICKLE-FIT Trial Summary
This trial studied the effectiveness of a personalized exercise program for adults with sickle cell disease, to improve physical health and quality of life.
Who is the study for?
This trial is for adults with Sickle Cell Disease (SCD) who can speak English fluently. Participants must have a confirmed diagnosis of any genotype of SCD. It's not suitable for those with unstable heart disease, severe cognitive issues, wheelchair users, oxygen-dependent individuals, or those who've had successful stem cell transplants for SCD.Check my eligibility
What is being tested?
The study is testing the Gerofit Exercise Program to see if it's safe and effective in improving physical health and quality of life in adults with SCD. The program will be personalized to each participant's abilities and needs.See study design
What are the potential side effects?
Since this is an exercise-based intervention, potential side effects may include muscle soreness, fatigue, joint pain or discomfort during or after exercise sessions. However, the program aims to minimize risks by personalizing activities.
SICKLE-FIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with sickle cell disease through a specific blood test.
SICKLE-FIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility, as measured by number of participants completing at least 50% of the exercise sessions
Secondary outcome measures
Acceptability, as measured by acceptability survey
Safety, as measured by number of participants with moderate or severe adverse events
Other outcome measures
Change in aerobic endurance as measured by Six-Minute Walk Test
Change in balance as measured by Timed Up and Go
Change in lower body strength as measured by 30-second chair stand
+3 moreSICKLE-FIT Trial Design
1Treatment groups
Experimental Treatment
Group I: ExerciseExperimental Treatment1 Intervention
Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,476 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,700 Previous Clinical Trials
7,508,534 Total Patients Enrolled
Charity I Oyedeji, MDPrincipal InvestigatorDuke University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition called avascular necrosis that is severe enough to require a medical device to assist you.I have been diagnosed with sickle cell disease through a specific blood test.I have significant hearing or vision loss that hasn't been corrected.I need oxygen support to breathe.I do not have unstable heart conditions.You are able to speak and understand English well.You are currently pregnant.I have had a successful stem cell transplant for sickle cell disease.I use a wheelchair for mobility.I have been diagnosed with moderate or severe memory or thinking problems.I am unable to give consent by myself.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial currently accessible to individuals seeking treatment?
"As indicated on clinicaltrials.gov, this study is actively enrolling participants right now. It was made publically available on March 27th 2023 and has since been revised April 19th of the same year."
Answered by AI
To what extent has this study been implemented among patients?
"Affirmative. The clinical trial is still actively recruiting, according to the details available on clinicaltrials.gov. It was initially posted on March 27th 2023 and has since been modified as of April 19th 2023 with a goal of enrolling 30 people from 1 location(s)."
Answered by AI
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