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治験 NCT07234513(対象:糖尿病)は完了です。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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Diabetes Mellitus Symptoms Related to Physical Competence 58
治験(臨床試験)の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします!「治験解説」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 NCT07234513 は 観察研究 臨床試験 で、糖尿病 を対象とした研究でした。現在は 完了 です。2018年12月3日 に開始し、58 名の参加者 が参加しました。この試験は Suleyman Demirel University によって主導され、2025年7月7日 に完了しました。ClinicalTrials.gov からの最新更新日は 2025年11月18日 です。
概要
The research is a cross-sectional study and was planned to determine which diabetes mellitus symptoms related to physical competence have a greater impact on balance in patients with diabetes mellitus
詳細説明
The present study was designed as a cross-sectional observational study to investigate the relationship between diabetes mellitus (DM)-related symptoms and physical competence, with a specific focus on balance performance in individuals diagnosed with DM. Considering that diabetes is a chronic metabolic disease that frequently leads to multisystemic complications such as peripheral neuropathy, muscle weakness, sensor...もっと見る
公式タイトル
Diabetes Mellitus Symptoms Related to Physical Competence: Do They Predict Dynamic Balance?
疾患名
糖尿病その他の研究識別子
- 60116787-020/71477
NCT番号
開始日
2018-12-03
最終更新日
2025-11-18
終了予定日
2025-07-07
目標参加者数
58
試験の種類
観察研究
状況
完了
キーワード
Diabetes Mellitus
Dynamic Balance
Physical Activity
Exertion
Urinary Incontinence
Dynamic Balance
Physical Activity
Exertion
Urinary Incontinence
群(アーム)/介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
1 There will be only one group in the study. | There will be no intervention in the study. Only descriptive tests will be used. There will be no intervention in the study. Only descriptive tests will be used. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Dynamic balance | Four-Step Square Test (FSST): Two strips were placed perpendicular to each other on the floor to create 4 squares. At the start of the test, the patient stood on square 1 facing square 2. The stepping sequence was as follows: 2-3-4-1-4-3-2-1. Participants were instructed to complete the sequence as fast as possible, without touching the canes or strips, and to ensure that both feet fully contacted the ground in each square. If the participant failed to complete the sequence correctly, lost balance, or touched the cane, the test was repeated. The total time required to complete the test was recorded | 7 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
International Physical Activity Questionnaire-Long Form (IPAQ-LF) | The IPAQ-LF consists of 27 items designed to assess physical activity across various domains, such as of housework, gardening, work activities, transportation, and leisure activities. The weekly physical activity level was calculated as metabolic equivalent of task (MET), by multiplying the activity duration in the previous week. An increase in the score indicates a high level of physical activity. According to the results, participants can be classified as inactive, minimally active, or very active.
Inactive (Category 1): The lowest level of physical activity. Situations that do not meet the criteria for Categories 2 or 3 are considered "inactive."
Minimally Active (Category 2): Achieving a minimum of 600 MET-min/week, with vigorous activity performed for at least 20 minutes per day on 3 or more days.
Very Active (Category 3): At least 3 days of vigorous activity achieving a minimum of 1500 MET-min/week. | 7 months |
6-Minute Walking Test (6MWT) | 6-Minute Walking Test (6MWT): The 6MWT is a valid, reliable, and gold standard maximal exercise effort test, that evaluates functional capacity and aerobic efficiency. The 6MWT was performed between two cones placed 30 m apart. Before the test, the physiotherapist recorded the vital signs (blood pressure, heart rate and respiratory rate per minute). The participants were asked to walk as fast as possible for 6 min and were informed in the last 1 min. If the patient had to stop walking within 6 min, they were asked to lean against the wall, but no patient stopped walking. The assessments were repeated at the end of the 6MWT, and the walking distance was recorded in meters. | 7 months |
Modified Borg Scale (MBS) | Modified Borg Scale (MBS): The MBS is a modified version of the Borg Rating of Perceived Exertion Scale, which was developed to quantify the subjective level of effort experienced during physical activity. The scale is commonly used in clinical rehabilitation to quantify the rates of fatigue-related perceived exertion between 0 and 10. "0" equates to "at rest" and "10" equates to "very, very hard". | 7 months |
International Urinary Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF) | International Urinary Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF): The ICIQ-UI SF, consisting of 6 items questioning the frequency, amount, and duration of urinary incontinence, and the impact of these complaints on daily life. The ICIQ-UI SF, is a short and simple questionnaire, that is useful in screening incontinence and obtaining brief but comprehensive data on the level, impact, and perceived effects of incontinence symptoms. The highest possible score on the questionnaire is 21. A higher score indicates a greater impact of incontinence. | 7 months |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
25 Years
対象性別
全て
- having Diabetes MEllitus
- having a Mini Mental Test (MMT) score ≥ 24
- the presence of comorbid conditions that could affect balance, such as lower extremity injuries, musculoskeletal surgery, diabetic neuropathy, orthopedic, neurological and cardiovascular diseases, and hearing or vision problems.
責任者
Mehmet Duray, 主任研究者, Assoc. Prof., Suleyman Demirel University
連絡先情報がありません。
1 1カ国の場所
Suleyman Demirel University, Isparta, 32200, Turkey (Türkiye)