Effectiveness of 4-weeks home based flexibility and resistance exercise program on structural profile and the shoulder girdle function for women with breast cancer
Objective: Structural Profile and Shoulder Girdle Function in Breast Cancer Survivors: Effect of Home-Based Exercise Program
Study design: Randomized, Double bind, with control group (no intervention)
Study population: women with breast cancer referred cancer treatment centers in Isfahan
Inclusion and Exclusion criteria: Postmenopausal Women; Age: 45-65; Diagnosed with stage I–III breast cancer; Undergone Unilateral Modified Radical Mastectomy, at least 12 months before; Radiotherapy and chemotherapy has been completed, underwent hormone therapy at the time of study; No new record for torso, chest or neck musculoskeletal rehabilitation, six months before breast cancer diagnosis; No regular exercise or fewer than two exercise sessions per weeks, at last 6 months.
Sample: n=80
Interventions: a resistance exercise with therapeutic band and flexibility exercise at home.
Duration of intervention: 4 weeks, 4 days per week
The primary outcomes: shoulder girdle posture, strength, flexibility & function improvement
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052213432N1
Registration date:2014-03-11, 1392/12/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-11, 1392/12/20
Registrant information
Name
Mahdie Akoochakian
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 76 4443 0055
Email address
makoochakian@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Tehran
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of 4-weeks home based flexibility and resistance exercise program on structural profile and the shoulder girdle function for women with breast cancer
Public title
Effect of Home Based Exercise Programe on posture,Shoulder Girdle Strength, Flexibility & Function in Breast cancer Survivours
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Women, Age: 40-65; Diagnosed with stage I–III breast cancer; Underwent radical mastectomy , at least 12 months before; Radiotherapy and chemotherapy has been completed, Underwent hormone therapy at the time of study; No new record Rehabilitation torso, Chest or neck musculoskeletal rehabilitation, six months before breast cancer diagnosis; No neurological, muscular dysfunction or taking drugs that may affect the neuromuscular function; No distant metastases; Sedentary lifestyle (no regular exercise or fewer than two exercise sessions per week); Exclusion criteria: Uncontrolled hypertension; Congestive heart failure; Pulmonary disease, diabetes, and thyroid or musculoskeletal disease
Age
From 40 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
semi - Experimental Research
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Tehran
Street address
Department of sport science, University of Tehran, Kish International Campus, Mirmohana Boulevard, Kish Island
City
Kish
Postal code
Approval date
2012-12-05, 1391/09/15
Ethics committee reference number
15/9/1391
Health conditions studied
1
Description of health condition studied
Malignant neoplasm of breast
ICD-10 code
C50.0
ICD-10 code description
Nipple and areola
2
Description of health condition studied
Malignant neoplasm of breast
ICD-10 code
C50.1
ICD-10 code description
Central portion of breast
3
Description of health condition studied
Malignant neoplasm of breast
ICD-10 code
C50.2
ICD-10 code description
Upper-inner quadrant of breast
4
Description of health condition studied
Malignant neoplasm of breast
ICD-10 code
C50.3
ICD-10 code description
Lower-inner quadrant of breast
5
Description of health condition studied
Malignant neoplasm of breast
ICD-10 code
C50.4
ICD-10 code description
Upper-outer quadrant of breast
6
Description of health condition studied
Malignant neoplasm of breast
ICD-10 code
C50.5
ICD-10 code description
Lower-outer quadrant of breast
7
Description of health condition studied
Malignant neoplasm of breast
ICD-10 code
C50.6
ICD-10 code description
Axillary tail of breast
8
Description of health condition studied
Malignant neoplasm of breast
ICD-10 code
C50.8
ICD-10 code description
Overlapping lesion of breast
9
Description of health condition studied
Malignant neoplasm of breast
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified
Primary outcomes
1
Description
body posture
Timepoint
berfore intervention, one month after
Method of measurement
photography
2
Description
shoulder strength
Timepoint
berfore intervention, one month after
Method of measurement
lafayyet manual muscle testing system
3
Description
shoulder range of motion
Timepoint
berfore intervention, one month after
Method of measurement
inclinometer
4
Description
shoulder function
Timepoint
berfore intervention, one month after
Method of measurement
DASH and PSS qustioner
Secondary outcomes
1
Description
fatigue
Timepoint
before intervention, one month after
Method of measurement
piper fatigue questioner
2
Description
quality of life
Timepoint
before intervention, one month after
Method of measurement
cancer rehabilitation evaluation system short form (CARES-SF)
Intervention groups
1
Description
intervention.4 weeks home based mobility and resistance exercises (4 sessions per week)
Category
Rehabilitation
2
Description
the control group receives no intervention except routine cares
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Prevention Research Center, Isfahan Seyedolshohada Hospital, Isfahan University of Medical Sc
Full name of responsible person
Dr Faranak Parastegari
Street address
Next To Seyedolshohada Hospital, Alley Farshady Creek, The Khayyam Highway, Shiry Bridge, Isfahan.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Tehran
Full name of responsible person
Dr hossein rajabi
Street address
Department of Sport Sciences, Kish International Campus, University of Tehran, Kish Island
City
Kish Island
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tehran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Mahdie Akoochakian
Position
phd
Other areas of specialty/work
Street address
Kish International Campus,University of Tehran,Mirmohana Boulevard, Kish Island
City
Kish
Postal code
Phone
+98 7647644430055
Fax
Email
makoochakian@ut.ac.ir/makochakian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Mahdie Akoochakian
Position
PHD
Other areas of specialty/work
Street address
University of Tehran, Kish International Campus, Mirmohana Boulevard, Kish Island