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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in haemoglobin A1c (HbA1c) levels
기간: 4 months
|
The measurement of HbA1c is carried out with a DCCT-aligned method.
|
4 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Body weight
기간: 4 months
|
4 months
|
|
|
Change in Fasting plasma glucose levels
기간: 4 months
|
4 months
|
|
|
Change in Total Cholesterol levels
기간: 4 months
|
4 months
|
|
|
Change in HDL Cholesterol levels
기간: 4 months
|
4 months
|
|
|
Change in LDL Cholesterol levels
기간: 4 months
|
4 months
|
|
|
Change in Triglycerides levels
기간: 4 months
|
4 months
|
|
|
Change in Blood Pressure
기간: 4 months
|
4 months
|
|
|
도보 6분 거리의 변화
기간: 4개월
|
이 테스트는 30m 코스를 6분 동안 걸을 수 있는 미터 수를 측정합니다.
유산소 기능 능력을 평가하기 위한 간단한 필드 테스트입니다.
|
4개월
|
|
Change in C-reactive protein levels
기간: 4 months
|
4 months
|
|
|
Change in Energy expenditure through voluntary physical activity
기간: 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
기간: 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
기간: 4 months
|
Attendance at the scheduled walking sessions is recorded for each patient.
|
4 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Paolo Moghetti, M.D., Ph.D., Universita di Verona
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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