Exercise and Radiotherapy, a Good Combination?

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908023
• Other study ID #: 2013/271
• Status: Completed
• Phase: N/A
• First received: July 23, 2013
• Last updated: April 26, 2017
• Start date: May 2013
• Est. completion date: January 2014

Study information

• Verified date: April 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Surgery for breast cancer.

• Completed chemotherapy treatment.

• Radiotherapy is scheduled.

Exclusion Criteria:

• metastatic disease

• pregnancy

• drug abuse

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Norway	St Olavs Hospital, Klinikk for Kliniske Servicefunksjoner	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in physical performance	aerobic capacity (VO2peak)	from baseline to 6 weeks
Secondary	perceived coping	Patient Activation Measure (PAM)	from baseline to 6 weeks
Secondary	Range of motion		from baseline to 6 weeks
Secondary	quality of life	questionnaire SF-36	from baseline to 6 weeks
Secondary	activity level	International physical activity questionnaire	from baseline to 6 weeks
Secondary	balance	Functional Reach	from baseline to 6 weeks