Exercise and Radiotherapy, a Good Combination?

Exercise and Radiotherapy, a Good Combination? A Pilot Study of Group Exercise for Patients With Breast Cancer

Every year, almost 3000 Norwegian women are diagnosed with breast cancer. Various symptoms of short-and long-term side effects may be experienced, such as physical deterioration, reduced quality of life and fatigue. At St.Olavs Hospital, Trondheim University Hospital, all out-patients undergoing post operative radiotherapy are currently offered participation in group exercise training sessions. The main purpose of this study is to evaluate these out-patient group exercise sessions.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Behavioral: exercise

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs Hospital, Klinikk for Kliniske Servicefunksjoner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Surgery for breast cancer.
• Completed chemotherapy treatment.
• Radiotherapy is scheduled.

Exclusion Criteria:

• metastatic disease
• pregnancy
• drug abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise	Behavioral: exercise; One hour, twice a week, for 5 weeks: warming-up with aerobic exercises, endurance exercises, strength exercises for large muscle groups, body awareness, range-of- motion exercises for the shoulders and stretching and relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in physical performance	aerobic capacity (VO2peak)	from baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perceived coping	Patient Activation Measure (PAM)	from baseline to 6 weeks
Range of motion		from baseline to 6 weeks
quality of life	questionnaire SF-36	from baseline to 6 weeks
activity level	International physical activity questionnaire	from baseline to 6 weeks
balance	Functional Reach	from baseline to 6 weeks

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: Principal Investigator: Inger L Aamot, phd, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: July 23, 2013
• First Submitted That Met QC Criteria: July 23, 2013
• First Posted (Estimate): July 25, 2013

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: exercise therapy; oxygen consumption
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2013/271

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No