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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Beijing
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Beijing, Beijing, China, 100084
- School of Sport Medicine and Rehabilitation，Beijing Sport University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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Experimenteel: 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. |
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Experimenteel: 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. |
Wandelgroep, Chinese vierkante dansgroep en controlegroep krijgen één keer per maand dezelfde gezondheidsvoorlichtingsbrochures of gezondheidsvoorlichtingslezingen.
Specifieke inhoud van de brochure of lezing zijn onder andere: diabetes type 2, hypertensie gerelateerde medische kennis en het belang van interventiebehandeling; preventie van diabetes type 2, hypertensie aanbevelingen voor voeding en lichaamsbeweging; basiskennis van wetenschappelijke oefening en de zaken die aandacht behoeven.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change from Baseline Systolic Blood Pressure at 3 months
Tijdsspanne: Before and after interventions（3 months)
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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.
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Before and after interventions（3 months)
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Change from Baseline Fasting Blood Glucose at 3 months
Tijdsspanne: Before and after interventions（3 months）
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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.
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Before and after interventions（3 months）
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Tijd en frequentie van bijwerkingen en ernstige bijwerkingen tijdens de voltooiing van het onderzoek
Tijdsspanne: Elke dag tijdens de interventies tot het einde van de studie (3 maanden)
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Deze studie verzamelt de volgende veiligheidsinformatie en legt deze vast in het CRF, waaronder: onderzoeksgerelateerde bijwerkingen en ernstige bijwerkingen. De relevante definities en procedures zijn als volgt. De nadelige effecten van lichaamsbeweging zijn: cardiovasculaire en cerebrovasculaire aandoeningen, verergering van complicaties die verband houden met diabetes/hypertensie en sportblessures. Ernstige ongewenste voorvallen (SAE's) worden gedefinieerd als aandoeningen die resulteren in een van de volgende uitkomsten na inspanningsinterventie: overlijden, levensbedreigend, ziekenhuisopname, blijvende of significante invaliditeit, disfunctie. Als zich in de loop van het onderzoek een SAE voordoet, moet de onderzoeker de proefpersoon onmiddellijk de juiste behandeling geven en het onderzoek beëindigen. Bijwerkingen worden dagelijks door de onderzoeker opgevraagd. In het geval van een bijwerking moet de onderzoeker het volgende in het CRF vastleggen: het tijdstip, de ernst, de eindtijd, de genomen maatregelen en het resultaat van de bijwerking. |
Elke dag tijdens de interventies tot het einde van de studie (3 maanden)
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Change from Cardiorespiratory Fitness at 3 months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Before and after interventions（3 months）
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Before and after interventions（3 months）
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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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Zhengzhen Wang, Doctor, Beijing Sport Uninversity
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Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2016YFC1300202
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