NCT01709175

Brief Summary

The purpose of this study is to compare once-a-week vs. twice-a-week strength training in survivors of breast and gynecologic cancer to determine which is the optimal exercise prescription.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2012

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

First Submitted

Initial submission to the registry

October 9, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

2.2 years

First QC Date

October 9, 2012

Last Update Submit

June 4, 2015

Conditions

Keywords

CancerBreast CancerGynecologic CancerStrength TrainingExercisePhysical ActivityFatigueQuality of LifeStrengthFitnessCancer SurvivorSurvivor

Outcome Measures

Primary Outcomes (1)

  • Changes in Muscular Strength

    Muscular Strength will be assessed using the predicted one-repetition maximum method (Brzycki method)using the bench press and leg press to measure upper and lower body strength.

    Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)

Secondary Outcomes (6)

  • Process Measures

    Final (end of week 13)

  • Changes in Muscular Endurance

    Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)

  • Changes in Body Composition

    Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)

  • Changes in Quality of Life

    Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)

  • Changes in Fatigue

    Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)

  • +1 more secondary outcomes

Study Arms (2)

Once-a-week Strength Training

EXPERIMENTAL

After completing the introduction to strength training (two sessions in the first week), participants randomized to the once-a-week group will receive 12 additional weeks of progressive strength training. Participants will meet ONCE-A-WEEK to strength train in a supervised exercise group. The program includes nine exercises.

Behavioral: Strength Training

Twice-a-week Strength Training

EXPERIMENTAL

After completing the introduction to strength training (two sessions in the first week), participants randomized to the twice-a-week group will receive 12 additional weeks of progressive strength training. Participants will meet TWICE-A-WEEK to strength train in a supervised exercise group. The program includes nine exercises.

Behavioral: Strength Training

Interventions

This is a 13 week strength training program. Sessions will be supervised by a Certified Exercise Physiologist in a group setting.

Also known as: Resistance Exercise, Weight Training, Body Building, Exercise, Physical Activity, Restive Exercise
Once-a-week Strength TrainingTwice-a-week Strength Training

Eligibility Criteria

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

You may qualify if:

  • Female Survivor of Breast or Gynecologic Cancer
  • Completed Primary Treatment (hormone treatments are ok)
  • years of age or older
  • Physician's Permission to Participate

You may not qualify if:

  • High Risk Individuals (determined by questionnaire)
  • Secondary Health Problems that could increase the risk of participating (Includes but not limited to: Uncontrolled angina/hypertension, heart failure, osteoporosis, brain metastases, history of seizures).
  • Report participating in a strength training program in the past six (6) months
  • Have had a change in medication in the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Lab: Queen Elizabeth II Dickson Centre

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsUterine NeoplasmsUterine Cervical NeoplasmsNeoplasmsMotor ActivityFatigue

Interventions

Resistance TrainingSomatotypesExercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine DiseasesUterine Cervical DiseasesBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPhysical Appearance, BodyBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysiological Phenomena

Study Officials

  • Scott Grandy, Ph D

    CDHA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 18, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations