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治験 NCT05896852（対象：HIV-1感染、代謝症候群）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ジョージタウン大学Healthy Lifestyles: A Home Based Physical Activity Intervention in Persons Living With HIV
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 NCT05896852 は 介入研究 臨床試験 で、HIV-1感染、代謝症候群 に関するものです。現在は 実施中／登録終了 で、2023年10月1日 から開始しています。50 名の参加者 の募集が計画されています。この治験は ジョージタウン大学 によって主催され、2026年10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21日 です。
概要
This study is being done to understand how a physical activity walking intervention affects metabolic parameters (i.e., blood sugar, cholesterol, certain body measurements) in people with and without HIV. This study involves a physical activity intervention where participants will progressively increase activity as tolerated over a six month period.
詳細説明
This study is being done to understand how a physical activity walking intervention affects metabolic parameters (i.e., blood sugar, cholesterol, certain body measurements) in people with and without HIV. This study involves a physical activity intervention where participants will progressively increase the total number of daily steps to approximately 10,000 steps/day as tolerated. We will monitor participant steps and physical activity using a physical activity monitor. The study will consist of 5 in-person study visits where participants will complete body measurements, laboratory testing (for metabolic parameters e.g. blood sugar and cholesterol), and a questionnaire.
公式タイトル
Healthy Lifestyles: A Home Based Physical Activity Intervention in Persons Living With HIV
疾患／病気
HIV-1感染代謝症候群その他の研究識別子
- STUDY00004962
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
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Intervention Arm Participants will increase their physical activity over 6 months as tolerated, | 身体活動 Participants will increase their physical activity through walking. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Acceptability of Study Activities (Recruitment) | To determine acceptability of study activities investigators will determine overall recruitment and determine percentage of the target recruitment that enrolled in the study at the 6 month study completion point (goal = 90% of our target). | 6 months |
Acceptability of Study Activities (Attrition) | Investigators will measure attrition by determination of the number of participants who complete all study visits (measured by total number of participants who complete the baseline, 3-month, and 6-month study visits - goal \>75%). These will be assessed at the end of the 6-month study period. | 6 months |
Adherence to Study Activities of Study Activities | Investigators will determine adherence to study activities by determination of the completion of study visits, completion of laboratory testing at study visits, and completion of step counting journals. Investigators will assess total number of documented study visits, completion of laboratory testing, and assessment of total number of days steps were entered in step logs. Investigators will assess the total number of visits, laboratory blood draws, and entries in to step log at each visit and determine overall percentage completed. | 6 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Metabolic Parameters (Laboratory Measurement - blood glucose) | Laboratory measurements including fasting blood glucose (mg/dL) will be at baseline, 3-month, and 6-month visits. Change (increase/decrease) in the fasting blood glucose measurement will be assessed. | 6 months |
Metabolic Parameters (Laboratory Measurement - lipids) | Laboratory measurements including lipids (mg/dL) will be at baseline, 3-month, and 6-month visits. Change (increase/decrease) in the lipid measurements will be assessed. | 6 months |
Metabolic Parameters (Laboratory Measurement - HBA1c) | Laboratory measurements including HBA1c (mmol/mol) will be measured at baseline, 3-month, and 6-month visits. Change (increase/decrease) in the HBA1c measurement will be assessed. | 6 months |
Body Composition (Waist Circumference [cm]) | Body measurement including waist circumference in centimeters will be assessed at baseline, 3-month, and 6-month follow-up visits. Changes (increase/decrease) waist circumference will be assessed. | 6 months |
Body Composition (BMI [kg/m^2]) | Body measurement including BMI \[kg/m\^2\] will be assessed at baseline, 3-month, and 6-month follow-up visits. Changes (increase/decrease) BMI will be assessed. | 6 months |
Quality of Life (Health-Related Quality of Life (SF-36)) | Health related quality of life will be assessed using the Health-Related Quality of Life (SF-36) scale. The scale includes eight measures - physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Scores range from 0 (worst) to 100 (best). Changes will be assessed from baseline to responses at the 6 month follow-up. | 6 months |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Age ≥ 18
- Persons living with or without HIV
- Metabolic Syndrome or risk factors for metabolic syndrome with BMI >=30
- Able to provide informed consent
- No physical limitations that prevent walking for more than 10 minutes
- Can provide evidence of medical clearance by healthcare provider, if required before or during the study
- Currently exercising regularly (at least 2x weekly of at least 20minutes of moderate or vigorous activity)
- Current enrollment in another physician activity and/or dietary clinical trial or on diet/weight-loss program
- Active plans for bariatric surgery
- Inability to commit to the intervention schedule
- Not eligible as per screening form
- Currently pregnant or planning to become pregnant
ジョージタウン大学75 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
District of Columbia
Georgetown University, Washington D.C., District of Columbia, 20007, United States