NCT01274806

Brief Summary

Effectiveness of a physical therapy program focussed on core stability exercise and massage as a recovery method in breast cancer survivors after oncology treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2010

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
Last Updated

January 12, 2011

Status Verified

January 1, 2009

Enrollment Period

1.4 years

First QC Date

December 22, 2010

Last Update Submit

January 11, 2011

Conditions

Breast Cancer

Keywords

breast cancerphysical therapymassagecore stability

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Fatigue Related Cancer at 6 months

    Piper Fatigue Scale

    Baseline, 6 months

Secondary Outcomes (3)

  • Change from Baseline in strength at 6 months

    Baseline, six months

  • Change from Baseline in Quality of Life at 6 months

    Baseline, six months

  • Change from Baseline in profile of mood state at 6 months

    Baseline, six months

Study Arms (2)

Usual care

NO INTERVENTION

Physical therapy

EXPERIMENTAL
Other: Physical Therapy

Interventions

Physical TherapyOTHER

Core Stability Exercise, Endurance training, recovery massage

Also known as: Exercise, Relaxation techniques, Recovery techniques
Physical therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Finished oncology treatment (chemotherapy, radiation, surgery)

You may not qualify if:

  • Other musculoskeletal conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences

Granada, Granada, 18071, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Physical Therapy ModalitiesExerciseRelaxation TherapyPost-Exercise Recovery Techniques

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMind-Body TherapiesComplementary TherapiesBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Manuel Arroyo-Morales, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 22, 2010

First Posted

January 12, 2011

Study Start

January 1, 2009

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

January 12, 2011

Record last verified: 2009-01

Locations

ES(1)