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Effects of Different Training Programs in Chronic Disease Patients

21. december 2018 opdateret af: Beijing Sport Uninversity

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

360

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100084
        • School of Sport Medicine and Rehabilitation，Beijing Sport University
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 69 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. 40-69 years of age

  2. 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

  3. Maintain the current state of medication for the next 3 months
  4. Lived in the current community in the past six months
  5. Have no intention of moving out for the next three months
  6. 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
  7. Sign informed consent

Exclusion Criteria:

  1. Manual works(such as farmers, couriers, athletes and workers, who rely on physical activity to make a living)
  2. Physical disability that prevents patients from walking or Chinese square dancing
  3. Currently enrolled in another lifestyle intervention trial(interventions such as nutrition, psychology, exercise and health education)
  4. Pregnant or planning to become pregnant
  5. BMI(body mass index)≥35 kg/m2
  6. Answers to questions 2, 3 and 6 of the questionnaire in 2014PAR-Q+ are "yes"
  7. 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.)
  8. Fasting blood glucose of diabetic patients is 13.8-16.7 mmol/L and urinary ketone is positive
  9. Severe complications of diabetes affecting exercise , such as foot, eye disease and renal insufficiency
  10. Complicated with other serious chronic diseases such as asthma, malignant tumor, chronic heart failure, severe depression or other mental disorders

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Walking group
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.
Eksperimentel: 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.
Adfærdsmæssigt: Chinese square dancing group

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.
Eksperimentel: 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.
Adfærdsmæssigt: Kontrolgruppe
Gågruppe, kinesisk kvadratdansende gruppe og kontrolgruppe får de samme sundhedspædagogiske brochurer eller sundhedspædagogiske foredrag en gang om måneden. Specifikt indhold af brochuren eller foredraget omfatter: type 2 diabetes, hypertension relateret medicinsk viden og betydningen af ​​interventionsbehandling; forebyggelse af type 2 diabetes, hypertension ernæring og motion anbefalinger; grundlæggende viden om videnskabelig udøvelse og dens forhold, der kræver opmærksomhed.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline Systolic Blood Pressure at 3 months
Tidsramme: 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
Tidsramme: 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）

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tid og hyppighed af uønskede reaktioner og alvorlige bivirkninger gennem undersøgelsens afslutning
Tidsramme: Hver dag under interventionerne indtil slutningen af ​​undersøgelsen (3 måneder)

Denne undersøgelse vil indsamle følgende sikkerhedsoplysninger og registrere dem i CRF, herunder: forskningsrelaterede bivirkninger og alvorlige bivirkninger. De relevante definitioner og procedurer er som følger.

De negative virkninger af træning omfatter: kardiovaskulære og cerebrovaskulære sygdomme, forværring af komplikationer forbundet med diabetes/hypertension og sportsskader. Alvorlige bivirkninger (SAE'er) defineres som tilstande, der resulterer i et af følgende udfald efter træningsintervention: død, livstruende, hospitalsindlæggelse, permanent eller betydelig invaliditet, dysfunktion.

Hvis der opstår en SAE i løbet af undersøgelsen, bør investigator straks tage passende behandling af emnet og afslutte forsøget. Bivirkninger spørges dagligt af forskeren. I tilfælde af en bivirkning er investigator forpligtet til at registrere følgende i CRF: tidspunktet, sværhedsgraden, sluttidspunktet, trufne foranstaltninger og resultatet af den uønskede hændelse.
Hver dag under interventionerne indtil slutningen af ​​undersøgelsen (3 måneder)
Change from Cardiorespiratory Fitness at 3 months
Tidsramme: Before and after interventions（3 months）
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.
Before and after interventions（3 months）
Change from Muscle Strength at 3 months
Tidsramme: Before and after interventions（3 months）
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.
Before and after interventions（3 months）
Change from Muscle Endurance at 3 months
Tidsramme: 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.
Before and after interventions（3 months）
Change from Flexibility at 3 months
Tidsramme: Before and after interventions（3 months）
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.
Before and after interventions（3 months）
Change from Balance at 3 months
Tidsramme: Before and after interventions（3 months）
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.
Before and after interventions（3 months）
Change from Body Composition at 3 months
Tidsramme: 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.
Before and after interventions（3 months）

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beijing Sport Uninversity

Samarbejdspartnere

Peking University

Efterforskere

  • Studieleder: Zhengzhen Wang, Doctor, Beijing Sport Uninversity

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. marts 2019

Primær færdiggørelse (Forventet)

1. november 2019

Studieafslutning (Forventet)

1. december 2020

Datoer for studieregistrering

Først indsendt

29. november 2018

Først indsendt, der opfyldte QC-kriterier

21. december 2018

Først opslået (Faktiske)

24. december 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. december 2018

Sidst verificeret

1. december 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2016YFC1300202

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