Physical Activity Intervention Trial to Mitigate Muscle Loss and Increase Muscle Strength
10. december 2020 opdateret af: Karolinska Institutet
Physical Activity Intervention Trial to Mitigate Muscle Loss and Increase Muscle Strength in Esophageal Cancer Survivors
This intervention study will be conducted on patients included in a nationwide and prospective cohort, The Oesophageal Surgery in Cancer patients: Adaptation and Recovery study (OSCAR). The OSCAR includes patients operated on for oesophageal cancer in Sweden between 2013-2018, identified through pathology departments and included in the cohort 1 year after surgery. A comprehensive interview is conducted by a research nurse during a home visit using patient reported outcomes on several HRQOL, psychosocial, emotional and nutritional aspects. Regular follow-ups are carried out at 1½, 2, 2½, 3, 4 and 5 years postoperatively.
All patients within OSCAR are invited to the intervention trial. Half of the eligible patients will be randomised to intervention and half to standard care (control group) by means of block randomisation method. The intervention group will be encouraged to adhere to a physical activity regimen of 150 minutes of weekly minimum intensity activities and 5 simple strength training exercises twice a week as instructed by the research nurse. The control group will follow their routine daily physical activity. HRQOL measures, height and weight, body composition, muscle strength, functional mobility and strength, and dietary intake are assessed before and after the intervention. Compliance will be ensured by means of a daily physical activity dairy and a weekly follow up on telephone with all patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
162
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Stockholm, Sverige
- Surgical cares sciences, Karolinksa Institutet
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- All patients from the nationwide prospective cohort the Oesophageal Surgery in Cancer patients: Adaptation and Recovery study (OSCAR) with willingness to participate
Exclusion Criteria:
- Current malignancies or co-morbidities, psychological or social conditions that prevent participation
- Patients with pacemakers; cochlear or other electrical implants cannot be screened using the bio-impedance scale for safety reasons
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 |
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Eksperimentel: Physical activity intervention group
The physical activity program includes 150 minutes of minimum intensity activity during a week (e.g.
walking, swimming) and five strength training exercises (10 repetitions and 2 sets of: squats, wall push ups, rowing with resistance band, shoulder press with resistance band, hip abduction) targeting the major muscle groups to do twice a week are demonstrated by the research nurse.
The resistance training is progressive by increasing resistance in the band based on patient's adaptability during the intervention.
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150 minutes of minimum intensity activity during a week (e.g.
walking, swimming) and five strength training exercises (10 repetitions and 2 sets of: squats, wall push ups, rowing with resistance band, shoulder press with resistance band, hip abduction) targeting the major muscle groups to do twice a week.
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Ingen indgriben: Standard care control group
Patients follow their routine daily physical activity.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants with treatment related increase in muscle mass as assessed by a bio-impedance body composition scale.
Tidsramme: At baseline and after the 12 weeks intervention/control programme.
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The main outcome measure will be increase in skeletal muscle mass using a bio-impedance analysis portable monitor.
Changes occurring during the period just before and just after the 12-weeks intervention programme, or standard of care in the comparison group, will be compared between the intervention group.
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At baseline and after the 12 weeks intervention/control programme.
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Number of participants with treatment related increase in muscle strength as assessed by a hand grip dynamometer and chair stand test.
Tidsramme: At baseline and after the 12 weeks intervention/control programme.
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The main outcome measure will be increase in skeletal muscle strength using a handgrip dynamometer and 30 second sit stand test.
Changes occurring during the period just before and just after the 12-weeks intervention programme, or standard of care in the comparison group, will be compared between the intervention group.
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At baseline and after the 12 weeks intervention/control programme.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants with improvement in physical function scale of health related quality of life as assessed from the questionnaire - European Organization for Research and Treatment of Cancer (EORTC); Quality of Life Questionnaire (QLQ) - C30.
Tidsramme: At baseline and after the12 weeks intervention/control programme.
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This secondary outcome will assess the physical function scale of HRQOL using EORTC QLQ-C30 questionnaires before and after the intervention.
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At baseline and after the12 weeks intervention/control programme.
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Number of participants with improvement in fatigue scale of health related quality of life as assessed from the questionnaire - EORTC QLQ-FA13.
Tidsramme: At baseline and after the12 weeks intervention/control programme.
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This secondary outcome will assess the fatigue scale of HRQOL using EORTC fatigue questionnaire QLQ-FA13 before and after the intervention.
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At baseline and after the12 weeks intervention/control programme.
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Number of participants with improvement in appetite loss function of health related quality of life as assessed from the oesophageal disease specific module - EORTC QLQ-OG25.
Tidsramme: At baseline and after the12 weeks intervention/control programme.
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This secondary outcome will assess the appetite loss function of HRQOL using EORTC QLQ-OG25 questionnaire before and after the intervention.
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At baseline and after the12 weeks intervention/control programme.
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Number of participants with improvement in eating difficulties scale of health related quality of life as assessed from the cachexia module of EORTC - QLQ-CAX24.
Tidsramme: At baseline and after the12 weeks intervention/control programme.
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This secondary outcome will assess the eating difficulties scale of HRQOL using EORTC QLQ-CAX24 questionnaire before and after the intervention.
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At baseline and after the12 weeks intervention/control programme.
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Number of participants with improvement in psycho social issues as assessed from the questionnaire - Hospital Anxiety and Depression Scale (HADS).
Tidsramme: At baseline and after the12 weeks intervention/control programme.
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This secondary outcome will assess the psychosocial issues using HADS questionnaire before and after the intervention.
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At baseline and after the12 weeks intervention/control programme.
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Number of participants with improvement in physical activity level measured using the international physical activity questionnaire (IPAQ).
Tidsramme: At baseline and after the 12 weeks intervention/control programme.
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This secondary outcome shall include changes in the total physical activity level measured using the international physical activity questionnaire (IPAQ) before and after the intervention.
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At baseline and after the 12 weeks intervention/control programme.
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Number of participants with improvement in dietary intake measured using 3 day food diary.
Tidsramme: Just before (baseline) and just after (final follow up) the 12 weeks intervention programme.
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This secondary outcome shall include changes in dietary intake measured using food dairy measured thrice a week: two weekdays and 1 weekend day before and after the intervention.
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Just before (baseline) and just after (final follow up) the 12 weeks intervention programme.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Pernilla Lagergren, Professor, Karolinska Institutet
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. januar 2016
Primær færdiggørelse (Faktiske)
1. juni 2020
Studieafslutning (Faktiske)
1. juni 2020
Datoer for studieregistrering
Først indsendt
28. april 2016
Først indsendt, der opfyldte QC-kriterier
16. maj 2016
Først opslået (Skøn)
17. maj 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. december 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. december 2020
Sidst verificeret
1. december 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PA study
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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