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

Karolinska Institute

Status: Terminated

Conditions: Oesophageal Cancer

Treatments: Behavioral: Physical activity intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT02774551

PA study

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

162 participants in 2 patient groups

Physical activity intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Physical activity intervention group

Standard care control group

No Intervention group

Description:

Patients follow their routine daily physical activity.