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Feasibility of Home-based Preoperative Exercise in Older People

7. august 2018 opdateret af: Elisabeth Rydwik, Karolinska Institutet

Preoperative Home-based Exercise in Older People Before Colorectal Surgery - a Feasibility Study

The purpose of the study is to evaluate the feasibility of recruitment procedure, intervention including compliance and the collaboration between in- and out patient clinics of preoperative home-based exercise in older people before colorectal surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The feasibility study will be conducted in order to evaluate the study design of a future RCT. Feasibility data will eg. consist of study flow description, number of eligible participants, included participants, patients and instructors satisfaction with the intervention, training compliance, reasons for drop-outs, and adverse events.

Patients waiting for colorectal surgery will be recruited and included after informed consent. Physical and respiratory function will be assessed at the hospital before the intervention, the day before surgery and the day before discharge. Data on postoperative complications, length of stay and mortality will be collected during the hospital stay. At baseline and six months after surgery, the participants will receive three questionnaires about level of independence in daily living, physical activity and health related quality of life. The intervention will be performed in the older person's home and consists of a combination of high-intensity respiratory training and individually adjusted functional exercise. Both groups will receive physical activity advice and malnutrition will be screened to optimize their nutritional status.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Sverige
      • Stockholm, Sverige, 11883
        • Stockholm South General 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

70 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age above 70, understand and speaks the Swedish language. Surgery due to cancer

Exclusion Criteria:

  • Health status that contradicts participation in the study such as unstable heart disease or severe orthopaedic conditions that prohibits training and severe systematic illness.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Exercise group
The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training.
Andet: Exercise
The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training.
Andet: Control group
The participants will receive ordinary preoperative information, but will also be encouraged to follow the recommendation of 150 minutes/week of moderate physical activity.
Andet: Exercise
The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment rate
Tidsramme: Six months
Number of participants included from eligible patients
Six months
Exercise compliance
Tidsramme: At the end of the intervention, after 2-4 weeks
Number of sessions attended out of planned sessions
At the end of the intervention, after 2-4 weeks
Acceptability
Tidsramme: At the end of the intervention, after 2-4 weeks
Patients and instructors satisfaction with the intervention measured with a survey
At the end of the intervention, after 2-4 weeks
Adverse events
Tidsramme: During the intervention, after 1-4 weeks
Musculoskeletal-related events , cardiovascular episodes, falls and health care use
During the intervention, after 1-4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Six-minute walk
Tidsramme: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Meters completed, effort estimated
Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Inspiratory muscle strength
Tidsramme: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Chair-stand 30-sec
Tidsramme: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Number
Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Walking speed (hab/max)
Tidsramme: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
10 meters
Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery
Postoperative complications
Tidsramme: Within the first 30 days of surgery
Clavien-Dindo, Delirium, Mortality
Within the first 30 days of surgery
Length of stay
Tidsramme: At discharge, 2-4 weeks after baseline
At discharge, 2-4 weeks after baseline
Discharge destination
Tidsramme: At discharge, 2-4 weeks after baseline
Care level after discharge from hospital (Home/Geriatric Clinic/Nursing Home)
At discharge, 2-4 weeks after baseline

Samarbejdspartnere og efterforskere

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

Sponsor

Karolinska Institutet

Samarbejdspartnere

Stockholm South General Hospital

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 (Faktiske)

1. september 2016

Primær færdiggørelse (Faktiske)

30. juni 2018

Studieafslutning (Faktiske)

30. juni 2018

Datoer for studieregistrering

Først indsendt

9. august 2016

Først indsendt, der opfyldte QC-kriterier

5. september 2016

Først opslået (Skøn)

9. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LS1311-1462

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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