Down Syndrome, Physical Inactivity
Conditions
Brief summary
The investigators are assessing acceptability, appropriateness, and feasibility of the adapted GameSquad-DS intervention using validated scales alongside qualitative data among young adults with Down Syndrome. Specifically, the investigators will assess mins/wk of Ring-Fit Adventure played, attendance at 30 min. virtual health coaching sessions, semi-structured interviews, participant retention, and intervention safety measured as number of adverse events.
Detailed description
Adults with DS face unique barriers to participation in MVPA. Exergames, which integrate MVPA into video game play are an affordable, accessible, home-based exercise program which has shown effectiveness for increasing MVPA and improving both physical and cognitive function in typically developed populations. An exergaming intervention with individual health coaching called GameSquad has been shown to be effective in improving MVPA and cardiometabolic parameters in children with overweight/obesity and adolescents with neurodevelopmental and psychiatric diagnoses. The investigators propose a two phased project to adapt/evaluate the GameSquad intervention for use in adults with DS (GameSquad-DS). In Phase 1, the investigators will utilize a formative approach to develop GameSquad-DS, pilot test the intervention for 4 weeks in 10 young adults with DS and use feedback to refine the intervention for use in Phase 2. In Phase 2, the investigators will conduct a 12-wk. single arm pilot trial in 20 young adults with DS to assess the acceptability, appropriateness, and feasibility of the intervention and calculate effect sizes for change MVPA, physical function, muscular strength, physical activity enjoyment, and self-efficacy. Successful completion of this project represents an initial step in achieving the goal of developing effective interventions to increase MVPA and promote healthy aging in adults with DS.
Interventions
BEHAVIORALRing-Fit Adventure Group
Participants will be asked to play the exergame software, Ring-Fit Adventure, and attend weekly virtual health coaching sessions.
Sponsors
HRSA/Maternal and Child Health Bureau
University of Kansas Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Young adults (18-30 yrs.). * Diagnosis of DS. * Sufficient functional ability to understand directions, communicate preferences, wants, and needs through spoken language. * Living at home with a parent/guardian or in a supported living environment with a parent/caregiver who agrees to serve as a study partner.
Exclusion criteria
* Unable to participate in MVPA. * Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by their primary care provider (PCP).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minutes of Gameplay Per Week | 12-weeks | Minutes of Ring-Fit Adventure played per week will be collected from a self-reported sign in sheet. |
| Retention | 12-weeks | Participant retention will be collected. |
| Attendance | 12-weeks | Attendance at 30 min virtual health coaching sessions will be collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand Grip Strength | 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. |
| Timed Up and Go | 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. |
| Qualitative Interview Data | 12-weeks | Semi-Structured interviews will occur after the 12-week intervention to allow participants to make sense of their experience in the intervention. |
| Adverse Events | 12-weeks | Adverse events will be collected. |
| Balance | 12-weeks | 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. |
| 6-minute Walk Test | 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. |
| Leg Strength | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | One participant ceased contact with the research study team after the initial, pre-testing appt. | 1 |
Baseline characteristics
| Characteristic | Ring-Fit Adventure Group |
|---|---|
| Age, Continuous | 23.2 years STANDARD_DEVIATION 3.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Attendance
Attendance at 30 min virtual health coaching sessions will be collected.
Time frame: 12-weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ring-Fit Adventure Group | Attendance | 92.45 percentage of attended sessions |
Primary
Minutes of Gameplay Per Week
Minutes of Ring-Fit Adventure played per week will be collected from a self-reported sign in sheet.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ring-Fit Adventure Group | Minutes of Gameplay Per Week | 100.32 minutes/week | Standard Deviation 8.65 |
Primary
Retention
Participant retention will be collected.
Time frame: 12-weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ring-Fit Adventure Group | Retention | 19 Participants |
Secondary
6-minute Walk Test
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.
Time frame: 12-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ring-Fit Adventure Group | 6-minute Walk Test | Pre-Test | 401.13 Meters | Standard Deviation 92.42 |
| Ring-Fit Adventure Group | 6-minute Walk Test | Post-Test | 399.26 Meters | Standard Deviation 81.45 |
Secondary
Adverse Events
Adverse events will be collected.
Time frame: 12-weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ring-Fit Adventure Group | Adverse Events | 0 Adverse Events |
Secondary
Balance
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ring-Fit Adventure Group | Balance | Post-test posteromedial reach right leg | 80.75 centimeters | Standard Deviation 12.32 |
| Ring-Fit Adventure Group | Balance | Pre-test posteromedial reach left leg | 76.79 centimeters | Standard Deviation 18.43 |
| Ring-Fit Adventure Group | Balance | Post-test posteromedial reach left leg | 80.38 centimeters | Standard Deviation 12.64 |
| Ring-Fit Adventure Group | Balance | Pre-test posterolateral reach right leg | 73.13 centimeters | Standard Deviation 22 |
| Ring-Fit Adventure Group | Balance | Post-Test posterolateral reach left leg | 70.83 centimeters | Standard Deviation 15.32 |
| Ring-Fit Adventure Group | Balance | Pre-test anterior reach right leg | 48.86 centimeters | Standard Deviation 16.37 |
| Ring-Fit Adventure Group | Balance | Post-test anterior reach right leg | 47.44 centimeters | Standard Deviation 7.57 |
| Ring-Fit Adventure Group | Balance | Pre-test anterior reach left leg | 47.63 centimeters | Standard Deviation 16.95 |
| Ring-Fit Adventure Group | Balance | Post-test anterior reach left leg | 49.14 centimeters | Standard Deviation 8.02 |
| Ring-Fit Adventure Group | Balance | Pre-test posteromedial reach right leg | 76.03 centimeters | Standard Deviation 17.49 |
| Ring-Fit Adventure Group | Balance | Post-test posterolateral reach right leg | 73.25 centimeters | Standard Deviation 15.68 |
| Ring-Fit Adventure Group | Balance | Pre-Test posterolateral reach left leg | 73.13 centimeters | Standard Deviation 17.69 |
Secondary
Hand Grip Strength
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.
Time frame: 12-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ring-Fit Adventure Group | Hand Grip Strength | Pre-Testing Left Grip | 20.36 Kilograms | Standard Deviation 8.8 |
| Ring-Fit Adventure Group | Hand Grip Strength | Post-Testing Left Grip | 19.58 Kilograms | Standard Deviation 7.56 |
| Ring-Fit Adventure Group | Hand Grip Strength | Pre-Testing Right Grip | 20.15 Kilograms | Standard Deviation 8.94 |
| Ring-Fit Adventure Group | Hand Grip Strength | Post-Testing Right Grip | 19.72 Kilograms | Standard Deviation 7.49 |
Secondary
Leg Strength
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.
Time frame: 12-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ring-Fit Adventure Group | Leg Strength | Pre-Test | 199.67 Pounds | Standard Deviation 83.34 |
| Ring-Fit Adventure Group | Leg Strength | Post-Test | 246.50 Pounds | Standard Deviation 91.61 |
Secondary
Qualitative Interview Data
Semi-Structured interviews will occur after the 12-week intervention to allow participants to make sense of their experience in the intervention.
Time frame: 12-weeks
Secondary
Timed Up and Go
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.
Time frame: 12-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ring-Fit Adventure Group | Timed Up and Go | Pre-Testing | 6.00 Seconds | Standard Deviation 1.61 |
| Ring-Fit Adventure Group | Timed Up and Go | Post-Testing | 6.14 Seconds | Standard Deviation 1.92 |