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Physical Activity Intervention Trial to Mitigate Muscle Loss and Increase Muscle Strength

10 december 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

162

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Zweden
      • Stockholm, Zweden
        • Surgical cares sciences, Karolinksa Institutet

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

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
Experimenteel: 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.
Gedragsmatig: Physical activity intervention group
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.
Geen tussenkomst: Standard care control group
Patients follow their routine daily physical activity.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants with treatment related increase in muscle mass as assessed by a bio-impedance body composition scale.
Tijdsspanne: At baseline and after the 12 weeks intervention/control programme.
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.
At baseline and after the 12 weeks intervention/control programme.
Number of participants with treatment related increase in muscle strength as assessed by a hand grip dynamometer and chair stand test.
Tijdsspanne: At baseline and after the 12 weeks intervention/control programme.
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.
At baseline and after the 12 weeks intervention/control programme.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: At baseline and after the12 weeks intervention/control programme.
This secondary outcome will assess the physical function scale of HRQOL using EORTC QLQ-C30 questionnaires before and after the intervention.
At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in fatigue scale of health related quality of life as assessed from the questionnaire - EORTC QLQ-FA13.
Tijdsspanne: At baseline and after the12 weeks intervention/control programme.
This secondary outcome will assess the fatigue scale of HRQOL using EORTC fatigue questionnaire QLQ-FA13 before and after the intervention.
At baseline and after the12 weeks intervention/control programme.
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.
Tijdsspanne: At baseline and after the12 weeks intervention/control programme.
This secondary outcome will assess the appetite loss function of HRQOL using EORTC QLQ-OG25 questionnaire before and after the intervention.
At baseline and after the12 weeks intervention/control programme.
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.
Tijdsspanne: At baseline and after the12 weeks intervention/control programme.
This secondary outcome will assess the eating difficulties scale of HRQOL using EORTC QLQ-CAX24 questionnaire before and after the intervention.
At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in psycho social issues as assessed from the questionnaire - Hospital Anxiety and Depression Scale (HADS).
Tijdsspanne: At baseline and after the12 weeks intervention/control programme.
This secondary outcome will assess the psychosocial issues using HADS questionnaire before and after the intervention.
At baseline and after the12 weeks intervention/control programme.
Number of participants with improvement in physical activity level measured using the international physical activity questionnaire (IPAQ).
Tijdsspanne: At baseline and after the 12 weeks intervention/control programme.
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.
At baseline and after the 12 weeks intervention/control programme.
Number of participants with improvement in dietary intake measured using 3 day food diary.
Tijdsspanne: Just before (baseline) and just after (final follow up) the 12 weeks intervention programme.
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.
Just before (baseline) and just after (final follow up) the 12 weeks intervention programme.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Karolinska Institutet

Onderzoekers

  • Hoofdonderzoeker: Pernilla Lagergren, Professor, Karolinska Institutet

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2016

Primaire voltooiing (Werkelijk)

1 juni 2020

Studie voltooiing (Werkelijk)

1 juni 2020

Studieregistratiedata

Eerst ingediend

28 april 2016

Eerst ingediend dat voldeed aan de QC-criteria

16 mei 2016

Eerst geplaatst (Schatting)

17 mei 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 december 2020

Laatste update ingediend die voldeed aan QC-criteria

10 december 2020

Laatst geverifieerd

1 december 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • PA study

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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