Trial Outcomes & Findings for GameSquad for Adults With Down Syndrome (NCT NCT05473247)

Results Overview

Minutes of Ring-Fit Adventure played per week will be collected from a self-reported sign in sheet.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

12-weeks

Results posted on

2024-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Ring-Fit Adventure Group In Phase 1, participants will be asked to play Ring-Fit Adventure for 60 minutes per week for 4 weeks. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. In Phase 2, participants will be asked to play Ring-Fit Adventure for 60 (wk 1), 90 (wk 2), 120 (wk 3), and 150 (wk 4-12) minutes per week. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. Ring-Fit Adventure Group: Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ring-Fit Adventure Group In Phase 1, participants will be asked to play Ring-Fit Adventure for 60 minutes per week for 4 weeks. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. In Phase 2, participants will be asked to play Ring-Fit Adventure for 60 (wk 1), 90 (wk 2), 120 (wk 3), and 150 (wk 4-12) minutes per week. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. Ring-Fit Adventure Group: Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.
Overall Study One participant ceased contact with the research study team after the initial, pre-testing appt.	1

Baseline Characteristics

GameSquad for Adults With Down Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ring-Fit Adventure Group n=20 Participants In Phase 1, participants will be asked to play Ring-Fit Adventure for 60 minutes per week for 4 weeks. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. In Phase 2, participants will be asked to play Ring-Fit Adventure for 60 (wk 1), 90 (wk 2), 120 (wk 3), and 150 (wk 4-12) minutes per week. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. Ring-Fit Adventure Group: Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.
Age, Continuous	23.2 years STANDARD_DEVIATION 3.83 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12-weeks

Minutes of Ring-Fit Adventure played per week will be collected from a self-reported sign in sheet.

Outcome measures

Outcome measures
Measure	Ring-Fit Adventure Group n=19 Participants In Phase 1, participants will be asked to play Ring-Fit Adventure for 60 minutes/week for 4 weeks. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. In Phase 2, participants will be asked to play Ring-Fit Adventure for 60 (wk 1), 90 (wk 2), 120 (wk 3), and 150 (wk 4-12) minutes/week. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. Ring-Fit Adventure Group: Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.
Minutes of Gameplay Per Week	100.32 minutes/week Standard Deviation 8.65

PRIMARY outcome

Timeframe: 12-weeks

Participant retention will be collected.

Outcome measures

Outcome measures
Measure	Ring-Fit Adventure Group n=20 Participants In Phase 1, participants will be asked to play Ring-Fit Adventure for 60 minutes/week for 4 weeks. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. In Phase 2, participants will be asked to play Ring-Fit Adventure for 60 (wk 1), 90 (wk 2), 120 (wk 3), and 150 (wk 4-12) minutes/week. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. Ring-Fit Adventure Group: Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.
Retention	19 Participants

PRIMARY outcome

Timeframe: 12-weeks

Attendance at 30 min virtual health coaching sessions will be collected.

Outcome measures

Outcome measures
Measure	Ring-Fit Adventure Group n=228 health coaching sessions In Phase 1, participants will be asked to play Ring-Fit Adventure for 60 minutes/week for 4 weeks. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. In Phase 2, participants will be asked to play Ring-Fit Adventure for 60 (wk 1), 90 (wk 2), 120 (wk 3), and 150 (wk 4-12) minutes/week. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. Ring-Fit Adventure Group: Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.
Attendance	92.45 percentage of attended sessions

SECONDARY outcome

Timeframe: 12-weeks

This test measures the distance that a participant can walk on a flat, hard surface in a period of 6 minutes. The research team will instruct them on how to prepare and conduct this test.

Outcome measures

Outcome measures
Measure	Ring-Fit Adventure Group n=19 Participants In Phase 1, participants will be asked to play Ring-Fit Adventure for 60 minutes/week for 4 weeks. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. In Phase 2, participants will be asked to play Ring-Fit Adventure for 60 (wk 1), 90 (wk 2), 120 (wk 3), and 150 (wk 4-12) minutes/week. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. Ring-Fit Adventure Group: Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.
6-minute Walk Test Pre-Test	401.13 Meters Standard Deviation 92.42
6-minute Walk Test Post-Test	399.26 Meters Standard Deviation 81.45

SECONDARY outcome

Timeframe: 12-weeks

Leg strength will be measured on the leg press machine. Researchers will assess the maximum amount of weight the participant can press for 5 repetitions.

Outcome measures

Outcome measures
Measure	Ring-Fit Adventure Group n=19 Participants In Phase 1, participants will be asked to play Ring-Fit Adventure for 60 minutes/week for 4 weeks. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. In Phase 2, participants will be asked to play Ring-Fit Adventure for 60 (wk 1), 90 (wk 2), 120 (wk 3), and 150 (wk 4-12) minutes/week. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. Ring-Fit Adventure Group: Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.
Leg Strength Pre-Test	199.67 Pounds Standard Deviation 83.34
Leg Strength Post-Test	246.50 Pounds Standard Deviation 91.61

SECONDARY outcome

Timeframe: 12-weeks

The participant will be asked to squeeze a device as hard as they can to test their grip strength. This will be done on both hands.

Outcome measures

Outcome measures
Measure	Ring-Fit Adventure Group n=19 Participants In Phase 1, participants will be asked to play Ring-Fit Adventure for 60 minutes/week for 4 weeks. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. In Phase 2, participants will be asked to play Ring-Fit Adventure for 60 (wk 1), 90 (wk 2), 120 (wk 3), and 150 (wk 4-12) minutes/week. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. Ring-Fit Adventure Group: Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.
Hand Grip Strength Pre-Testing Left Grip	20.36 Kilograms Standard Deviation 8.80
Hand Grip Strength Post-Testing Left Grip	19.58 Kilograms Standard Deviation 7.56
Hand Grip Strength Pre-Testing Right Grip	20.15 Kilograms Standard Deviation 8.94
Hand Grip Strength Post-Testing Right Grip	19.72 Kilograms Standard Deviation 7.49

SECONDARY outcome

Timeframe: 12-weeks

During this test, the participant will be asked to sit down in a chair. Approximately 10 feet in front of the participant there will be a line on the floor. The research team will say "go" and the participant will get up from the chair, walk to the line at a normal pace, and then turnaround and walk back to the chair and sit down again. The research team will record how long it takes to do this.

Outcome measures

Outcome measures
Measure	Ring-Fit Adventure Group n=19 Participants In Phase 1, participants will be asked to play Ring-Fit Adventure for 60 minutes/week for 4 weeks. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. In Phase 2, participants will be asked to play Ring-Fit Adventure for 60 (wk 1), 90 (wk 2), 120 (wk 3), and 150 (wk 4-12) minutes/week. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. Ring-Fit Adventure Group: Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.
Timed Up and Go Pre-Testing	6.00 Seconds Standard Deviation 1.61
Timed Up and Go Post-Testing	6.14 Seconds Standard Deviation 1.92

SECONDARY outcome

Timeframe: 12-weeks

Population: Various participants could not complete certain aspects of the Y-balance test. 3 trials were allowed for each test to ensure testing finished on-time and prevented excess frustration

During this test, the investigators will ask the participant to balance on one leg and reach in three directions as far as they can with their other foot. They will then do the same on the other leg.

Outcome measures

Outcome measures
Measure	Ring-Fit Adventure Group n=19 Participants In Phase 1, participants will be asked to play Ring-Fit Adventure for 60 minutes/week for 4 weeks. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. In Phase 2, participants will be asked to play Ring-Fit Adventure for 60 (wk 1), 90 (wk 2), 120 (wk 3), and 150 (wk 4-12) minutes/week. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. Ring-Fit Adventure Group: Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.
Balance Pre-test anterior reach right leg	48.86 centimeters Standard Deviation 16.37
Balance Post-test anterior reach right leg	47.44 centimeters Standard Deviation 7.57
Balance Pre-test anterior reach left leg	47.63 centimeters Standard Deviation 16.95
Balance Post-test anterior reach left leg	49.14 centimeters Standard Deviation 8.02
Balance Pre-test posteromedial reach right leg	76.03 centimeters Standard Deviation 17.49
Balance Post-test posteromedial reach right leg	80.75 centimeters Standard Deviation 12.32
Balance Pre-test posteromedial reach left leg	76.79 centimeters Standard Deviation 18.43
Balance Post-test posteromedial reach left leg	80.38 centimeters Standard Deviation 12.64
Balance Pre-test posterolateral reach right leg	73.13 centimeters Standard Deviation 22
Balance Post-test posterolateral reach right leg	73.25 centimeters Standard Deviation 15.68
Balance Pre-Test posterolateral reach left leg	73.13 centimeters Standard Deviation 17.69
Balance Post-Test posterolateral reach left leg	70.83 centimeters Standard Deviation 15.32

SECONDARY outcome

Timeframe: 12-weeks

Adverse events will be collected.

Outcome measures

Outcome measures
Measure	Ring-Fit Adventure Group n=19 Participants In Phase 1, participants will be asked to play Ring-Fit Adventure for 60 minutes/week for 4 weeks. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. In Phase 2, participants will be asked to play Ring-Fit Adventure for 60 (wk 1), 90 (wk 2), 120 (wk 3), and 150 (wk 4-12) minutes/week. Participants will also be asked to attend a weekly, 90 minute health education session with a health educator on zoom. Ring-Fit Adventure Group: Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.
Adverse Events	0 Adverse Events

SECONDARY outcome

Timeframe: 12-weeks

Semi-Structured interviews will occur after the 12-week intervention to allow participants to make sense of their experience in the intervention.

Outcome measures

Outcome data not reported

Adverse Events

Ring-Fit Adventure Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kameron Suire

Berry College

Phone: 3373968980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place