Physical Activity Intervention Trial to Mitigate Muscle Loss and Increase Muscle Strength
10. Dezember 2020 aktualisiert von: 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.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
162
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Stockholm, Schweden
- Surgical cares sciences, Karolinksa Institutet
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Kein Eingriff: Standard care control group
Patients follow their routine daily physical activity.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Number of participants with treatment related increase in muscle mass as assessed by a bio-impedance body composition scale.
Zeitfenster: 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.
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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).
Zeitfenster: 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).
Zeitfenster: 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.
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Pernilla Lagergren, Professor, Karolinska Institutet
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Januar 2016
Primärer Abschluss (Tatsächlich)
1. Juni 2020
Studienabschluss (Tatsächlich)
1. Juni 2020
Studienanmeldedaten
Zuerst eingereicht
28. April 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
16. Mai 2016
Zuerst gepostet (Schätzen)
17. Mai 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
14. Dezember 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. Dezember 2020
Zuletzt verifiziert
1. Dezember 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- PA study
Plan für individuelle Teilnehmerdaten (IPD)
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