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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 7/9/2025 | Other Identifier | UW Madison | |
| EDUC/KINESIOLOGY | Other Identifier | UW Madison |
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The purpose of this study is to determine the feasibility and acceptability of a 10-week supervised Physical Activity program for mothers of children with developmental disabilities. 30 participants will be enrolled: 15 into an Intervention group and 15 into a Waitlist Control group.
The specific aims of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Activity Program | Experimental | This group will enroll in the 10-week program immediately. |
|
| Waitlist Control | Active Comparator | This group will enroll and then be offered the 10-week program next year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity Program | Behavioral | Three 60-minute supervised group exercise sessions per week for 10 weeks, led by a certified instructor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Recruitment Rate | through enrollment (up to 12 weeks) | |
| Feasibility: Percent of Sessions Attended | up to 12 weeks | |
| Feasibility: Number of Participants Who Complete the study | up to 12 weeks | |
| Acceptability: Participant Experiences | Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count. | up to 12 weeks |
| Acceptability: Participant Satisfaction | Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count. | up to 12 weeks |
| Acceptability: Challenges to Participation | Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count. | up to 12 weeks |
| Acceptability: Facilitators to Participation | Measured qualitatively via semi-structured post-intervention interviews, summarized and reported by participant count. | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Grip Strength | The participant will squeeze a handheld dynamometer as hard as possible to measure hand and forearm strength, recorded in kilograms. | baseline, week 5, week 10 |
| Efficacy: Number of Push-Ups Participant Completes with Proper Form |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Columna, PhD | UW Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| D001321 | Autistic Disorder |
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000067877 | Autism Spectrum Disorder |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Waitlist for Physical Activity Program | Behavioral | Three 60-minute supervised group exercise sessions per week for 10 weeks, led by a certified instructor. |
|
The participant will perform as many push-ups as possible with proper form to test upper-body endurance. |
| baseline, week 5, week 10 |
| Efficacy: Five Times Sit to Stand Test (FTSST) | The amount of time it takes for a participant to transfer from seated to standing and back to sitting five times. | baseline, week 5, week 10 |
| Efficacy: Percent Body Fat and Lean Mass | Body composition is measured via Bioelectrical Impedance Analysis (BIA). The participant will stand barefoot on a bioelectrical impedance device to estimate body fat and muscle levels. | baseline, week 5, week 10 |
| Efficacy: Fat Mass and Fat-Free Mass in Kilograms | Body composition is measured via Bioelectrical Impedance Analysis (BIA). The participant will stand barefoot on a bioelectrical impedance device to estimate body fat and muscle levels. | baseline, week 5, week 10 |
| Generalized Anxiety Disorder-7 (GAD-7) | Scored from 0-21 where higher scores indicate increased anxiety. | baseline, week 5, week 10 |
| Perceived Stress Scale (PSS) | Scored from 0-40 where higher scores indicate increased stress. | baseline, week 5, week 10 |
| Patient Health Questionnaire-8 (PHQ-8) | Scored from 0-24 where higher scores indicate increased symptoms of depression | baseline, week 5, week 10 |
| Penn State Worry Questionnaire (PSWQ) | Scored from 16-80 where higher scores indicate increased worry. | baseline, week 5, week 10 |
| SF-12 Health Survey | Perceived physical and mental health subscales each scored from 0-100 with higher scores indicating better perceived physical and mental health. | baseline, week 5, week 10 |
| International Physical Activity Questionnaire (IPAQ) | The IPAQ assesses physical activity during the previous 7 days by asking participants how many days and how many minutes per day they engaged in vigorous activity, moderate activity, walking, and sitting. The responses are converted into metabolic equivalent (MET) minutes per week by multiplying the minutes of activity per week by an assigned MET value (walking = 3.3 METs, moderate activity = 4.0 METs, vigorous activity = 8.0 METs). The total physical activity score is the sum of MET-minutes/week across the activity categories. Higher scores reflect greater levels of physical activity. | baseline, week 5, week 10 |
| D002659 |
| Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |