Trial Outcomes & Findings for Gerofit Exercise Intervention for Older Adults With Sickle Cell Disease (SICKLE-FIT Study) (NCT NCT05714098)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

12 weeks

Results posted on

2026-06-30

Participant Flow

One participant was withdrawn by the PI due to weekly hospitalizations and never started the program. Two participants consented but never completed the safety orientation and never started the program. Both cited a busy schedule and inability to make the time commitment.

Participant milestones

Participant milestones
Measure	Exercise Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gerofit Exercise Intervention for Older Adults With Sickle Cell Disease (SICKLE-FIT Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise n=30 Participants Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback.
Age, Continuous	53.4 years STANDARD_DEVIATION 9.65 • n=20 Participants
Sex: Female, Male Female	21 Participants n=20 Participants
Sex: Female, Male Male	9 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	26 Participants n=20 Participants
Race (NIH/OMB) White	0 Participants n=20 Participants
Race (NIH/OMB) More than one race	3 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=20 Participants
Region of Enrollment United States	30 Participants n=20 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Exercise n=30 Participants Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback.
Feasibility, as Measured by Number of Participants Completing at Least 50% of the Exercise Sessions	25 Participants

SECONDARY outcome

Timeframe: 12 weeks

Number of participants with one or more moderate or severe adverse events within 48 hours after each exercise session.

Outcome measures

Outcome measures
Measure	Exercise n=30 Participants Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback.
Safety, as Measured by Number of Participants With Moderate or Severe Adverse Events Moderate AEs	3 Participants
Safety, as Measured by Number of Participants With Moderate or Severe Adverse Events Severe AEs	0 Participants

SECONDARY outcome

Timeframe: 12 weeks

Acceptability of the exercise program was measured on a scale of 1-10, where 1= severe dislike and 10 = absolute enjoyment. Reported as the number of participants with scores of 8-10.

Outcome measures

Outcome measures
Measure	Exercise n=30 Participants Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback.
Acceptability, as Measured by the Number of Participants Reporting the Intervention as Acceptable	29 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 24 weeks

Population: Four participants did not present for post-physical assessment.

Reported as the percent change in usual walking speed on a 4.57 meter (15 feet) walking course.

Outcome measures

Outcome measures
Measure	Exercise n=26 Participants Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback.
Percent of Participants With Clinically Meaningful Change in Mobility as Measured by Usual Gait Speed	46 percentage of participants Interval 27.0 to 65.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 12-24 weeks

Population: Four participants did not present for post-physical assessment.

Performance test of physical mobility. This measures the number of seconds it takes to stand up from a standard chair (46cm), walk a distance of 10 ft (3 meters), turn back to the chair, and sit down again.

Outcome measures

Outcome measures
Measure	Exercise n=26 Participants Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback.
Percent of Participants With Clinically Meaningful Change in Balance as Measured by Timed Up and Go	35 percentage of participants Interval 16.0 to 53.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 12-24 weeks

Population: One participant did not complete baseline 6MWT. Four participants did not present for post-physical assessment.

Measure of aerobic endurance. The participant walks as fast and as safely as possible for 6 minutes with prompts given every minute. Distance traveled in 6 minutes is recorded.

Outcome measures

Outcome measures
Measure	Exercise n=25 Participants Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback.
Percent of Participants With Clinically Meaningful Change in Aerobic Endurance as Measured by Six-Minute Walk Test (6MWT)	57 percentage of participants Interval 36.0 to 77.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 12-24 weeks

Population: Four participants did not present for post-physical assessment.

Measure of upper body strength. Jamar hydraulic hand dynamometer (Jamar Technologies) was used to measure grip strength in triplicate for both hands while subject remains seated. The greatest value was used in analysis.

Outcome measures

Outcome measures
Measure	Exercise n=26 Participants Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback.
Percent of Participants With Clinically Meaningful Change in Upper Body Strength as Measured by Grip Strength	7.7 percentage of participants Interval 0.0 to 18.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 12-24 weeks

Population: Four participants did not present for post-physical assessment.

30-second chair stand is a measure lower body strength. The participant sits in a folding chair without arms with chair pressed against the wall and stands up and sits back down with arms across their chest as many times as possible in 30 seconds.

Outcome measures

Outcome measures
Measure	Exercise n=26 Participants Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback.
Percent of Participants With Clinically Meaningful Change in Lower Body Strength as Measured by 30-second Chair Stand	31 percentage of participants Interval 13.0 to 49.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 12-24 weeks

Population: Four participants did not present for post-physical assessment.

Includes deep squat and mobility test of upper and lower extremities. This is measure of squat quality/form.

Outcome measures

Outcome measures
Measure	Exercise n=26 Participants Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback.
Percent of Participants With Improved Quality of Movement Measured by Functional Movement Screen	38 percentage of participants

Adverse Events

Exercise

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Exercise n=30 participants at risk Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback.
Blood and lymphatic system disorders Sickle Cell Pain Crisis	10.0% 3/30 • Up to 24 weeks

Additional Information

Charity Oyedeji, MD

Duke University

Phone: (919) 684-0628

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place