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Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients

12. august 2013 opdateret af: National Taiwan University Hospital

Cancer is one of the leading health issues in this country and worldwide. Angiogenesis is an essential process for tumoral growth and metastasis. This process is dependent on the balance between angiogenic factors and antiangiogenic factors. Muscle wasting has been associated with myostatin overexpression in cancer. Exercise training can depress tumor growth and suppress myostatin expression, and enhance skeletal muscle angiogenesis in healthy people and some animal studies. The purpose of this study is mainly to investigate the effects of exercise training on

  1. circulating VEGF-A
  2. muscle growth and function
  3. Myostatin

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital

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 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 40-75 years
  • Advanced NSCLC
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Targeted therapy for at least 8 weeks
  • Stable condition

Exclusion Criteria:

  • Severe metastasis, cardiopulmonary or musculoskeletal conditions may affect participation in exercise
  • Do not understand the verbal or written instructions

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Exercise training
Subjects in exercise group will undergo individualized high aerobic interval training on treadmill for 30 minutes under the supervision of an experienced physical therapist 3 times a week and home exercise twice a week with accelerometer.
Subjects in exercise group will undergo individualized high aerobic interval training on treadmill for 30 minutes under the supervision of an experienced physical therapist 3 times a week and home exercise twice a week with accelerometer.
Andre navne:
  • High intensity interval aerobic training
Aktiv komparator: Control group
Subjects in control group will not undergo individualized high aerobic interval training on treadmill. They will receive usual care as normally does in hospital.
Subjects in control group will not undergo individualized high aerobic interval training on treadmill. They will receive usual care as normally does in hospital.
Andre navne:
  • Non-exercise or patient education

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exercise capacity
Tidsramme: 8 weeks after the start of the intervention
Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS
8 weeks after the start of the intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Imaging of muscle
Tidsramme: 8 weeks and 16 weeks after the start of the intervention
Measured by MRS
8 weeks and 16 weeks after the start of the intervention
Analysis of venous blood sample
Tidsramme: 8 weeks andd 16 weeks after the start of the intervention
Analysis of circulating VEGF-A and myostatin
8 weeks andd 16 weeks after the start of the intervention
Quality of life
Tidsramme: baseline, 8 weeks, 16 weeks
Measured by questionnaire
baseline, 8 weeks, 16 weeks
Exercise capacity
Tidsramme: 16 weeks after the start of the intervention
Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS
16 weeks after the start of the intervention
Muscle function
Tidsramme: 8 weeks and 16 weeks after the start of the intervention
Isokinetic muscle strength and endurance with Biodex
8 weeks and 16 weeks after the start of the intervention
Physical activity
Tidsramme: 8 weeks andd 16 weeks after the start of the intervention
Measured with 7-day recall questionnaire
8 weeks andd 16 weeks after the start of the intervention
Dietary intake
Tidsramme: 8 weeks andd 16 weeks after the start of the intervention
Measured with 24-hour recall questionnaire
8 weeks andd 16 weeks after the start of the intervention
Body composition
Tidsramme: 8 weeks andd 16 weeks after the start of the intervention

Body mass index calculated with body weight and height

% body fat abd free-fat mass with BIA

8 weeks andd 16 weeks after the start of the intervention

Samarbejdspartnere og efterforskere

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

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

1. september 2010

Primær færdiggørelse (Faktiske)

1. august 2011

Studieafslutning (Faktiske)

1. august 2012

Datoer for studieregistrering

Først indsendt

10. maj 2010

Først indsendt, der opfyldte QC-kriterier

2. juni 2010

Først opslået (Skøn)

3. juni 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. august 2013

Sidst verificeret

1. november 2011

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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