Clinical trial NCT02774551: Physical Activity Intervention Trial to Mitigate Muscle Loss and Increase Muscle Strength
Official title: Physical Activity Intervention Trial to Mitigate Muscle Loss and Increase Muscle Strength in Esophageal Cancer Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Oesophageal Cancer
Keywords: Body composition
Muscle strength
Health related quality of life
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of participants with treatment related increase in muscle mass as assessed by a bio-impedance body composition scale.
timeFrame: At baseline and after the 12 weeks intervention/control programme.
measure: Number of participants with treatment related increase in muscle strength as assessed by a hand grip dynamometer and chair stand test.
timeFrame: At baseline and after the 12 weeks intervention/control programme.
Secondary outcomes:
measure: 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.
timeFrame: At baseline and after the12 weeks intervention/control programme.
measure: Number of participants with improvement in fatigue scale of health related quality of life as assessed from the questionnaire - EORTC QLQ-FA13.
timeFrame: At baseline and after the12 weeks intervention/control programme.
measure: 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.
timeFrame: At baseline and after the12 weeks intervention/control programme.
measure: 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.
timeFrame: At baseline and after the12 weeks intervention/control programme.
measure: Number of participants with improvement in psycho social issues as assessed from the questionnaire - Hospital Anxiety and Depression Scale (HADS).
timeFrame: At baseline and after the12 weeks intervention/control programme.
measure: Number of participants with improvement in physical activity level measured using the international physical activity questionnaire (IPAQ).
timeFrame: At baseline and after the 12 weeks intervention/control programme.
measure: Number of participants with improvement in dietary intake measured using 3 day food diary.
timeFrame: Just before (baseline) and just after (final follow up) the 12 weeks intervention programme.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Surgical cares sciences, Karolinksa Institutet
Study officials:
affiliation: Karolinska Institutet
name: Pernilla Lagergren, Professor
role: PRINCIPAL_INVESTIGATOR
References: