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

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ClinicalTrials.gov Identifier: NCT02774551
Recruitment Status : Suspended (Suspended since March 2020 due to the ongoing covid-19 situation)
First Posted : May 17, 2016
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Pernilla Lagergren, Karolinska Institutet

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Oesophageal Cancer Behavioral: Physical activity intervention group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Activity Intervention Trial to Mitigate Muscle Loss and Increase Muscle Strength in Esophageal Cancer Survivors
Study Start Date : January 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: 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.

No Intervention: Standard care control group
Patients follow their routine daily physical activity.



Primary Outcome Measures :
  1. Number of participants with treatment related increase in muscle mass as assessed by a bio-impedance body composition scale. [ Time Frame: 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.

  2. Number of participants with treatment related increase in muscle strength as assessed by a hand grip dynamometer and chair stand test. [ Time Frame: 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 dynamometer and chair 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.


Secondary Outcome Measures :
  1. 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. [ Time Frame: 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.

  2. Number of participants with improvement in fatigue scale of health related quality of life as assessed from the questionnaire - EORTC QLQ-FA13. [ Time Frame: 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.

  3. 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. [ Time Frame: 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.

  4. 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. [ Time Frame: 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.

  5. Number of participants with improvement in psycho social issues as assessed from the questionnaire - Hospital Anxiety and Depression Scale (HADS). [ Time Frame: 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.

  6. Number of participants with improvement in physical activity level measured using the international physical activity questionnaire (IPAQ). [ Time Frame: 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.

  7. Number of participants with improvement in dietary intake measured using 3 day food diary. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774551


Locations
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Sweden
Surgical cares sciences, Karolinksa Institutet
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Pernilla Lagergren, Professor Karolinska Institutet
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Responsible Party: Pernilla Lagergren, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02774551    
Other Study ID Numbers: PA study
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pernilla Lagergren, Karolinska Institutet:
Body composition
Muscle strength
Health related quality of life