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

NCT02774551 | Terminated

• 1 other identifier: PA study
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Oesophageal Cancer

Keywords

Body composition; Muscle strength; Health related quality of life

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment related increase in muscle mass as assessed by a bio-impedance body composition scale.

  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.

  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.

Secondary Outcomes (7)

• 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.

  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.

  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.

  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.

  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).

  At baseline and after the12 weeks intervention/control programme.

Study Arms (2)

Physical activity intervention group

EXPERIMENTAL

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

Standard care control group

NO INTERVENTION

Patients follow their routine daily physical activity.

Interventions

Physical activity intervention group BEHAVIORAL

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.

Physical activity intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients from the nationwide prospective cohort the Oesophageal Surgery in Cancer patients: Adaptation and Recovery study (OSCAR) with willingness to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Surgical cares sciences, Karolinksa Institutet

Stockholm, Sweden

Location

Related Publications (1)

• Anandavadivelan P, Malberg K, Vikstrom K, Nielsen S, Holdar U, Johar A, Lagergren P. Home-based physical activity after treatment for esophageal cancer-A randomized controlled trial. Cancer Med. 2023 Feb;12(3):3477-3487. doi: 10.1002/cam4.5131. Epub 2022 Aug 18.

  PMID: 36812121 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Pernilla Lagergren, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 17, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)