Supervised Walking Groups as a Model to Increase Physical Activity in Type 2 Diabetes
Assessment of Feasibility and Efficacy of a Project Aimed to Improve Metabolic Control in Type 2 Diabetes Through Lifestyle Changes and Self-monitoring of Blood Glucose
調査の概要
詳細な説明
Regular, moderate-intensity physical activity can attenuate hyperglycemia in subjects with type 2 diabetes. In addition, these programmes may favourably affect several other cardiovascular risk factors in these subjects. However, it still remains unclear how this evidence can be transferred into clinical practice, considering the very large number of diabetic patients and the characteristics of this population, made up predominantly of elderly, sedentary and overweight patients. In this regard, a realistic approach to this issue requires simple and easily available intervention models.
Walking is a typical mild-moderate aerobic physical activity which is easy to organize and does not require specific skills or preliminary sophisticated medical evaluations. This activity could therefore fit well with the need of involvement of large numbers of patients in different logistic situations. However, it has been reported that, due to the low walking speed typical of type 2 diabetic subjects, self-paced walking is inadequate to obtain a significant metabolic improvement in these subjects.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- diabetes known for at least 2 yr
- physical inactivity
- haemoglobin (Hb)A1c between 6.5-9.9%
- treatment with oral hypoglycaemic agents alone or associated with a bed-time insulin injection
- willingness to participate in a programme of regular physical activity
Exclusion Criteria:
- moderate-severe autonomic or somatic neuropathy
- severe lower limb vasculopathy
- pre-proliferative or proliferative active retinopathy
- moderate to severe chronic renal failure
- unstable angina or recent (in the previous 3 months) myocardial infarction
- acute intercurrent diseases
- acute metabolic decompensation (blood glucose >300 mg/dl or ketonuria in two consecutive checks)
- use of beta-blocker drugs
- subjects unable to complete a 6-min walk test
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Supervised walking groups
Patients included in walking groups, under the supervision of a qualified personal trainer.
|
Walk training, 3 sessions per week for 4 months, under the supervision of a qualified personal trainer.
|
|
アクティブコンパレータ：Controls
Patients receiving the standard counselling procedures of the Verona Diabetic Clinic.
|
Verbal and written information about the benefits of exercise and instructions aimed to encourage physical activity.
In addition, one group session of counselling on these issues.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in haemoglobin A1c (HbA1c) levels
時間枠：4 months
|
The measurement of HbA1c is carried out with a DCCT-aligned method.
|
4 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Body weight
時間枠：4 months
|
4 months
|
|
|
Change in Fasting plasma glucose levels
時間枠：4 months
|
4 months
|
|
|
Change in Total Cholesterol levels
時間枠：4 months
|
4 months
|
|
|
Change in HDL Cholesterol levels
時間枠：4 months
|
4 months
|
|
|
Change in LDL Cholesterol levels
時間枠：4 months
|
4 months
|
|
|
Change in Triglycerides levels
時間枠：4 months
|
4 months
|
|
|
Change in Blood Pressure
時間枠：4 months
|
4 months
|
|
|
徒歩6分で変化
時間枠：4ヶ月
|
30mのコースを6分間で何m走れるかを測るテストです。
有酸素運動能力を評価するための簡単なフィールドテストです。
|
4ヶ月
|
|
Change in C-reactive protein levels
時間枠：4 months
|
4 months
|
|
|
Change in Energy expenditure through voluntary physical activity
時間枠：4 months
|
Energy expenditure is estimated through 7-day activity diaries.
The intensity of each activity (defined in metabolic equivalents, MET) is multiplied by duration and the product for each activity is summed to give a total activity score in MET hours/week.
|
4 months
|
|
Change in Antidiabetic medications
時間枠：4 months
|
Class and dosage of blood-glucose lowering drugs are recorded before and at the end of the protocol, to assess changes in hypoglycemic medication during the trial.
|
4 months
|
|
Compliance with walking sessions
時間枠：4 months
|
Attendance at the scheduled walking sessions is recorded for each patient.
|
4 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Paolo Moghetti, M.D., Ph.D.、Universita di Verona
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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