- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03785886
Effects of Different Training Programs in Chronic Disease Patients
Intervention Effects and Safety Evaluation of Different Exercise Training Programs on Hypertension and Hypertension Complicated With Diabetes
The study is a randomized 3-month community-based exercise intervention with a control group and 2 different exercise groups: walking group and Chinese square dancing group.Eighteen communities will be selected in Beijing, and they will be age matched and randomly grouped into walking, Chinese square dancing and control groups. Each community will include twenty subjects (ten patients with hypertension and ten patients with hypertension complicated with diabetes) aged 40-69 years. All exercise sessions will be supervised and subject's exercise implementation process will be managed with intelligent equipment. The purpose of the study is to evaluate the effectiveness and safety of different training programs.
The demographics data, physical activity questionnaires, blood pressure, blood glucose, blood lipids, height, weight and physical fitness (cardiorespiratory fitness,muscle strength, muscle endurance, flexibility, body composition) will be measured before and after 3-month exercise training .The adverse reactions in the implementation of the interventions will be recorded. The primary outcomes are blood pressure and blood glucose.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
The global burden of disease study shows that unreasonable diets and physical inactivity are the largest health risks facing the world today. In recent years, foreign and domestic scholars have gradually introduced the concept of " Exercise is Medicine " guide the the public exercise scientifically. However, under the special cultural background of China, it is urgent to answer how to help the public to realize reasonable scientific exercise, how to choose the popular exercise mode and whether the exercise mode is scientific and effective.
Previous meta-analysis studies on the improvement of blood pressure and blood glucose by walking have been published, but few studies on Chinese square dancing have been conducted. Previous studies on whether Chinese square dancing was scientific and effective were mostly small sample population studies carried out by Chinese scholars. The research results were of large heterogeneity, and the research design lacked reasonable consideration.
This study intends to select two common exercise mode for scientific evaluation, one is walking and the other is Chinese square dancing. The purpose of this study is to evaluate the efficacy and safety of two common types of exercise (walking and Chinese square dancing) in Chinese patients with hypertension and patients with hypertension complicated with diabetes.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Beijing
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Beijing, Beijing, Kina, 100084
- School of Sport Medicine and Rehabilitation,Beijing Sport University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 40-69 years of age
Meet any one of the two conditions:
2.1 Hypertension: diagnosed with hypertension, systolic blood pressure is 130-159 mmHg, take no antihypertensive drug or no more than 2 kinds of antihypertensive drugs
2.2 Hypertension complicated with diabetes: diagnosed with hypertension and type 2 diabetes, systolic blood pressure is 130-159 mmHg and the fasting blood glucose in the past 2 weeks was 5.6-16.7 mmol/L (13.8-16.7 mmol/L was negative for urinary ketone) , take no more than 4 kinds of antihypertensive and hypoglycemic drugs
- Maintain the current state of medication for the next 3 months
- Lived in the current community in the past six months
- Have no intention of moving out for the next three months
- Have no regular exercise habit (moderate intensity activity less than 3 times a week, less than 30 minutes each time or 30 minutes cumulative), at least exercise 3 days a week
- Sign informed consent
Exclusion Criteria:
- Manual works(such as farmers, couriers, athletes and workers, who rely on physical activity to make a living)
- Physical disability that prevents patients from walking or Chinese square dancing
- Currently enrolled in another lifestyle intervention trial(interventions such as nutrition, psychology, exercise and health education)
- Pregnant or planning to become pregnant
- BMI(body mass index)≥35 kg/m2
- Answers to questions 2, 3 and 6 of the questionnaire in 2014PAR-Q+ are "yes"
- Cardio-cerebrovascular events have occurred in the past 6 months(heart disease diagnosed by doctors, such as coronary heart disease, hypertensive heart disease, acute myocarditis, pulmonary heart disease, etc.)
- Fasting blood glucose of diabetic patients is 13.8-16.7 mmol/L and urinary ketone is positive
- Severe complications of diabetes affecting exercise , such as foot, eye disease and renal insufficiency
- Complicated with other serious chronic diseases such as asthma, malignant tumor, chronic heart failure, severe depression or other mental disorders
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Walking group
The study is a randomized 3-month community-based exercise intervention with a control group and 2 different exercise groups: walking group and Chinese square dancing group. Eighteen communities will be selected in Beijing, and they will be age matched and randomly grouped into walking, Chinese square dancing and control groups. Each community will include twenty subjects (ten patients with hypertension and ten patients with hypertension complicated with type 2 diabetes) aged 40-69 years. |
Subjects in this group perform exercise consisting of walking for 30 - 60 min at 40% - 60% HRR intensity 3-5 d•wk-1 for 3 months .
Each training includes 5 min warm-up and 5 min cool-down, and the exercise should start after meals for 1 hour .
Heart rate is monitored by sports bracelet .
Subjects using β-blockers will not use heart rate to monitor exercise intensity , but RPE scores .
And RPE( Borg scale) scores are ranged from 11-13.
|
Experimentell: Chinese Square Dancing group
The study is a randomized 3-month community-based exercise intervention with a control group and 2 different exercise groups: walking group and Chinese square dancing group. Eighteen communities will be selected in Beijing, and they will be age matched and randomly grouped into walking, Chinese square dancing and control groups. Each community will include twenty subjects (ten patients with hypertension and ten patients with hypertension complicated with type 2 diabetes) aged 40-69 years. |
Chinese square dances have been selected from 24 sets of square dances jointly launched in 2015 and 2017. According to the age and physical health status of the subjects, six dance pieces of are selected as the repertoires of the intervention in this study. Subjects in this group perform exercise consisting of Chinese square dances for 30-60 min at 40% - 60% HRR intensity 3-5 d•wk-1 for 3 months. Each training includes 5 min warm-up and 5 min cool-down , and the exercise should start after meals for 1 hour. Make the subjects step for 30 s to 1 min between each track to adjust the heart rate. Heart rate is monitored by sports bracelet. Subjects using β-blockers will not use heart rate to monitor exercise intensity, but RPE scores. And RPE( Borg scale) scores are ranged from 11-13. |
Experimentell: Control group
The study is a randomized 3-month community-based exercise intervention with a control group and 2 different exercise groups: walking group and Chinese square dancing group. Eighteen communities will be selected in Beijing, and they will be age matched and randomly grouped into walking, Chinese square dancing and control groups. Each community will include twenty subjects (ten patients with hypertension and ten patients with hypertension complicated with type 2 diabetes) aged 40-69 years. |
Vandringsgrupp, kinesisk kvadratdansgrupp och kontrollgrupp får samma hälsoutbildningsbroschyrer eller hälsoutbildningsföreläsningar en gång i månaden.
Specifikt innehåll i broschyren eller föreläsningen inkluderar: typ 2-diabetes, hypertonirelaterade medicinska kunskaper och betydelsen av interventionsbehandling; förebyggande av typ 2-diabetes, högt blodtryck näring och motionsrekommendationer; grundläggande kunskaper om vetenskaplig utövande och dess frågor som kräver uppmärksamhet.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change from Baseline Systolic Blood Pressure at 3 months
Tidsram: Before and after interventions(3 months)
|
To evaluate the effect of walking and Chinese square dancing on systolic blood pressure in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
|
Before and after interventions(3 months)
|
Change from Baseline Fasting Blood Glucose at 3 months
Tidsram: Before and after interventions(3 months)
|
To evaluate the effect of walking and Chinese square dancing on fasting blood glucose in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
|
Before and after interventions(3 months)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Tid och frekvens för biverkningar och allvarliga biverkningar under studiens slutförande
Tidsram: Varje dag under interventionerna fram till slutet av studien (3 månader)
|
Denna studie kommer att samla in följande säkerhetsinformation och registrera den i CRF, inklusive: forskningsrelaterade biverkningar och allvarliga biverkningar. De relevanta definitionerna och procedurerna är följande. De negativa effekterna av träning inkluderar: kardiovaskulära och cerebrovaskulära sjukdomar, förvärring av komplikationer i samband med diabetes/hypertoni och idrottsskador. Allvarliga biverkningar (SAE) definieras som tillstånd som resulterar i något av följande resultat efter träningsintervention: död, livshotande, sjukhusvistelse, permanent eller betydande funktionsnedsättning, dysfunktion. Om en SAE uppstår under studiens gång, bör utredaren omedelbart ta lämplig behandling i ämnet och avsluta studien. Biverkningar frågas dagligen av forskaren. I händelse av en biverkning måste utredaren registrera följande i CRF: tidpunkten, svårighetsgraden, sluttid, vidtagna åtgärder och resultatet av biverkningen. |
Varje dag under interventionerna fram till slutet av studien (3 månader)
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Change from Cardiorespiratory Fitness at 3 months
Tidsram: Before and after interventions(3 months)
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To evaluate the effect of walking and Chinese square dancing on cardiorespiratory fitness in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
Cardiorespiratory fitness (2 minutes high knee lift) is in heart beats per minute.
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Before and after interventions(3 months)
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Change from Muscle Strength at 3 months
Tidsram: Before and after interventions(3 months)
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To evaluate the effect of walking and Chinese square dancing on muscle strength in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
Muscle strength (grip strength) is in kilograms.
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Before and after interventions(3 months)
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Change from Muscle Endurance at 3 months
Tidsram: Before and after interventions(3 months)
|
To evaluate the effect of walking and Chinese square dancing on muscle endurance in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
Muscle endurance (40-59 yrs: push-ups(male) or sit-ups(female), 60-69 yrs: 30-second chair stand test and 30-second arm curl test) is in numbers.
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Before and after interventions(3 months)
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Change from Flexibility at 3 months
Tidsram: Before and after interventions(3 months)
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To evaluate the effect of walking and Chinese square dancing on flexibility in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
Flexibility (40-59 yrs :reach test, 60-69 yrs : chair sit-and-reach test) is in centimeters.
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Before and after interventions(3 months)
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Change from Balance at 3 months
Tidsram: Before and after interventions(3 months)
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To evaluate the effect of walking and Chinese square dancing on balance in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
Balance (standing on one leg with eyes closed) is in seconds.
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Before and after interventions(3 months)
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Change from Body Composition at 3 months
Tidsram: Before and after interventions(3 months)
|
To evaluate the effect of walking and Chinese square dancing on body composition in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
Body composition (bioelectrical impedance ) is in percentage of weight.
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Before and after interventions(3 months)
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Zhengzhen Wang, Doctor, Beijing Sport Uninversity
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2016YFC1300202
Plan för individuella deltagardata (IPD)
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