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治験 NCT06496425 (iSTEP+)（対象：アルツハイマー病、身体活動）は募集中です。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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エモリー大学Inspiring Seniors Towards Exercise Promotion to Protect Cognition (iSTEP+)
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 NCT06496425 (iSTEP+) は 介入研究 臨床試験 で、アルツハイマー病、身体活動 に関するものです。現在は 募集中 で、2024年5月15日 から開始しています。80 名の参加者 の募集が計画されています。この治験は エモリー大学 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3月24日 です。
概要
The goal of this clinical trial is to test the benefits of beat-accented music stimulation (BMS) for behavioral changes of physical activity (PA) in older adults with subjective memory complaints. Specific Aims are to determine (1) whether BMS beneficially influences PA behaviors and psychological responses to PA in older adults for 6 months, and (2) whether exercising with BMS differently influences physical and cognitive functioning as well as quality of life in older adults.To test the effects of BMS on PA, participants will be randomly assigned to an exercise intervention that either includes BMS or does not include BMS. Participants will attend a supervised group strength training (ST) (30 min/day) and and aerobic exercise (AE) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/week for the next 2 months (while encouraging participants to independently perform both AE and ST on other days), and independently for the final 2 months (always with a goal of performing >150min/week AE and 3 days/week of ST for 30 min/day).
公式タイトル
Inspiring Seniors Towards Exercise Promotion to Protect Cognition
疾患／病気
アルツハイマー病身体活動刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- iSTEP+
- STUDY00008531
- AARF-23-1145107 (その他の助成金/資金番号) (Alzheimer's Association)
NCT番号
開始日
2024-05-15
最終更新日
2025-03-24
終了予定日
2026-10
目標参加者数
80
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
music
aerobic exercise
strength training
cognition
physical activity
muscular strength
memory complaint
aerobic exercise
strength training
cognition
physical activity
muscular strength
memory complaint
主目的
予防
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Exercise and music The strength training (ST) program incorporates single-leg exercises for balance training and training with resistance bands and body weight. During the ST, participants will be asked to synchronize their concentric and eccentric muscle contractions in time with the tempo of BMS playlists at a specific music tempo. For aerobic exercise (AE), participants will be instructed to walk at moderate intensity with duration increasing up to an ultimate goal of 150 min/week. Participants will be trained to walk in synchrony with the beats. Participants will receive individualized music playlists to match individual walking cadence and music preference. | 音楽 Those randomized to the exercise and music group will receive pre-recorded music playlists along with the exercise. During the strength training (ST), participants will be asked to sync their concentric and eccentric muscle contractions in time with the tempo of playlists. For aerobic exercise (AE), we will adjust the tempo of playlists to match individual walking cadence for participants to be trained to walk in sync with the beats of the playlists. |
非介入Exercise The ST program incorporates single-leg exercises for balance training and training with resistance bands and body weight. For AE, participants will be instructed to walk at moderate intensity with duration increasing up to an ultimate goal of 150 min/week. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Changes of physical activity behaviors as assessed by ActiGraph wGT3X-BT | Duration, intensity, and frequency of physical activity assessed using an waist-worn accelerometer | 7 consecutive days at Baseline (before the intervention) and during month 1, 2, 3, 4, 5, and 6 |
Affective responses to physical activity as assessed by Physical Activity Enjoyment Scale | Self-reported affective states relative to physical activity. Physical Activity Enjoyment Scale has 18 items based on a 7-point Likert scale and the total score is ranged from 18 to 126. | At baseline (before the intervention), month 3 and month 5 during the intervention, and post-test (within 4 weeks after the intervention) |
Adherence to the physical activity program | Daily duration of aerobic exercise and strength training is self-reported on an exercise log. | A daily exercise log for the entire 6-month period |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
General cognition as assessed using the Montreal Cognitive Assessment | Montreal Cognitive Assessment takes approximately 10 minutes for completion and the total score is ranged from 0 to 30. | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
Executive function as assessed using the Tower of London - Freiburg version | Tower of London - Freiburg version takes approximately 14 minutes to complete and measures the total number of items solved in minimum number of moves in the range from 0 to 12. | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
Executive function as assessed using the NIH Toolbox Flanker Inhibitory Control and Attention test | The Flanker Inhibitory Control and Attention test takes approximately 5 minutes to complete and measures the accuracy and reaction time to create a composite score, ranging from 0 to 10. | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
Executive function as assessed using the NIH Toolbox Dimensional Change Card Sort test | The Dimensional Change Card Sort test takes approximately 5 minutes to complete and measures the accuracy and reaction time to create a composite score, ranging from 0 to 10. | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
Executive function as assessed using the NIH Toolbox List Sorting Working Memory test | The List Sorting Working Memory test takes approximately 10 minutes to complete and measures the total number of items correctly recalled and sequenced, ranging from 0 to 26. | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
Episodic memory as assessed using the NIH Toolbox Picture Sequence Memory test | The Picture Sequence Memory test takes approximately 7 minutes to complete and measures the total number of items correctly placed, ranging from 0 to 31, and the IRT-based theta score, ranging from 200 to 700. | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
Episodic memory as assessed using the Mnemonic Similarity Task | This custom-developed test takes approximately 15 minutes to complete and measures mnemonic discrimination (a score ranging from 0-1) and visual recognition (a score ranging from 0-1). | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
Health-related quality of life as assessed using the RAND 36-Item Short-Form Health Survey | The RAND 36-Item Short-Form Health Survey Scale has 36 items for self-report, takes 10-15 minutes to complete, and measures health-related quality of life with a score ranging from 0 - 100. | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
Physical activity behaviors as assessed by physical activity and sedentary behaviour questionnaire. | The physical activity and sedentary behaviour questionnaire has 7 items and takes approximately 5 minutes for completion | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
The progress of aerobic capacity and endurance as assessed by 6-minute walk test | The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
The progress of balance, sit-to-stand, and walking as assessed by Timed Up and Go test | The time taken to complete a Timed Up and Go test is an indicator of fall risks. | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
The progress of lower-body strength as assessed by 30-Second Sit-to-Stand test | The number of sit-to-stand maneuvers completed in 30 seconds. | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
The progress of upper-body strength as assessed by Grip Strength test | The squeeze power in pounds measured by by a handheld dynamometer | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
The progress of balance as assessed by 4-Stage Balance Test | The duration of maintaining 4 difference postures | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
Individual differences in music-related reward experiences as assessed by the Barcelona Music Reward Questionnaire (BMRQ) | BMRQ has 24 items and takes 5-10 minutes to complete and measures music-related reward experiences with a score ranging from 0 to 100. | At pre-test (before the intervention) and post-test (within 4 weeks after the intervention). |
Treatment satisfaction as assessed by the Client Satisfaction Questionnaire (CSQ-8) | CSQ has 8 items and takes approximately 3 minutes to complete and measures self-reported satisfaction with the program with a score ranging from 0 to 32. | At post-test (within 4 weeks after the intervention). |
適格基準
対象年齢
高齢者
試験の最低年齢
65 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Adults at least 65 years old.
- Ambulatory/capable of walking for 6 minutes without pain or aid such as a walker/cane.
- Able to speak and read English.
- Healthy enough to exercise at moderate intensity with or without medical clearance by a primary care physician.
- Living in the community for the duration of the study (6 months).
- Having a reliable means of transportation.
- Having a safe place (at least 6 feet by 6 feet of open space) at home for unsupervised exercise training.
- Having self-perceived memory complaints.
- Having no symptoms of suicidal ideation and not meeting criteria for depressive disorder.
- Physically low-active by doing < 60 min/week of moderate-intensity aerobic exercise and no strength training for the last 3 months.
- Diagnosis of neurological disorder or spinal cord disorder.
- Known exercise contraindications.
- Current cancer treatment.
- Stroke or neural impairment in the past 6 months.
- Hip/knee/spinal fracture or surgery in the past 6 month.
- Unable or unwilling to attend intervention classes 3x/week in Months 1-2 and 1x/week in Months 3-4.
- Currently participating in any other physical activity or fitness-related research study.
- Use of medication for Alzheimer's disease. Change in dosage of medications prescribed for anxiety or depression within the previous 6 months.
- Regularly drink > 14 alcoholic beverages a week or current illicit drug use.
- Meet the threshold for cognitive impairment.
- Meet the threshold for clinical depression.
- Uncorrected hearing or visual impairments.
- Unable to understand the study procedures.
- One of the household members is participating in this study.
エモリー大学402 件のアクティブな治験を探索- Alzheimer's Association
- University of North Carolina, Greensboro
責任者
Kyoung Shin Park, PhD, 研究責任者, Assistant Professor, Emory University
試験中央連絡先
連絡先: Study Team, 404-727-8919, [email protected]
2 1カ国の場所
Georgia
Emory University, Atlanta, Georgia, 30324, United States
Study Team, 連絡先, 404-727-8919, [email protected]
Kyoung Shin Park, PhD, 研究責任者
募集中
North Carolina
UNC Greensboro, Greensboro, North Carolina, 27412, United States
Study Coordinator, 連絡先, 336-334-4765, [email protected]
募集中