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ウィスコンシン大学マディソン校10-Week Physical Activity Program for Mothers of Children With Developmental Disabilities
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07182071 は 介入研究 臨床試験 で、介護者負担 に関するものです。現在は 実施中／登録終了 で、2025年9月18日 から開始しています。19 名の参加者 の募集が計画されています。この治験は ウィスコンシン大学マディソン校 によって主催され、2026年6月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年10月17日 です。
概要
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.
詳細説明
The specific aims of this study are:
- Aim 1: Determine the feasibility and acceptability of a 10-week supervised resistance training program for mothers of autistic children.
- Aim 2: Determine the potential health benefits of the 10-week physical activity program on psychological and physical health outcomes.
公式タイトル
Feasibility of a 10-Week Physical Activity Program for Mothers of Children With Developmental Disabilities
疾患／病気
介護者負担その他の研究識別子
- 2025-0981
- Protocol Version 7/9/2025 (その他の識別子) (UW Madison)
- EDUC/KINESIOLOGY (その他の識別子) (UW Madison)
NCT番号
開始日
2025-09-18
最終更新日
2025-10-17
終了予定日
2026-06
目標参加者数
19
試験の種類
介入研究
治験の相・段階
該当なし
状況
実施中／登録終了
キーワード
mothers
autism
down syndrome
disabilities
fitness
autism
down syndrome
disabilities
fitness
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Physical Activity Program This group will enroll in the 10-week program immediately. | 身体活動プログラム Three 60-minute supervised group exercise sessions per week for 10 weeks, led by a certified instructor. |
実薬対照薬Waitlist Control This group will enroll and then be offered the 10-week program next year. | Waitlist for Physical Activity Program Three 60-minute supervised group exercise sessions per week for 10 weeks, led by a certified instructor. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 | 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 |
適格基準
対象年齢
成人
試験の最低年齢
25 Years
対象性別
女性
健康なボランティアを受け入れる
はい
- Be a mother of a child with a diagnosed developmental disability (e.g., autism spectrum disorder, Down syndrome, intellectual disability) ages 4-11.
- Be able to engage in moderate-intensity exercise three times per week.
- Be able to walk independently for at least a quarter of a mile without assistance.
- Have reliable childcare arrangements during program sessions (please note: childcare will not be provided).
- Be available and willing to attend scheduled assessments and group sessions throughout the 10-week program.
- Are currently pregnant.
- Have a physical disability or medical condition that prevents safe participation in physical activity.
- Are already engaged in physical activity programs more than twice per week.
- Have diagnosed mental health conditions that may interfere with consistent attendance or the ability to provide informed consent.
- Are unable to communicate effectively in English.
ウィスコンシン大学マディソン校247 件のアクティブな治験を探索連絡先情報がありません。
1 1カ国の場所
Wisconsin
University of Wisconsin, Madison, Wisconsin, 53705, United States