Protocol summary

Summary
Objectives: The purpose of this study was to determine the effect of 6 weeks of selected exercise on muscle strength, balance and core stability in women with breast cancer and healthy women. Design: This quasi-experimental study included 120 women in five groups, supervised resistance, supervised combination and home-base resistance and patient control (each n = 25) and healthy controls groups (n = 20) who were randomly selected and was performed at the Cancer Research Center of Isfahan University of Medical Sciences. The study was at the Phase 3 and single Blinded. Setting and conduct: After reviewing the 1230 cases and completion of inform consent by patients, qualified samples, initial assessment was carried out and after the 6 week, post -test was done. Participants: The main inclusion criteria were aged 29 to 65 years, diagnosed with breast cancer, the completion of treatment period in the 6 previous months. The main exclusion criteria were injury, onset or increased pain during exercise and disease recurrence. Interventions: Home based and supervised resistance training groups were done 13 exercises with theraband and supervised combination training group were done 15 exercises with theraband, medicine ball and their body weight, for 6 weeks. Each session lasted 90 minutes. Disease and the healthy control groups had no regular physical activity during the intervention. Main outcome measures: Primary outcomes were included muscle strength, balance, core stability and secondary outcomes were included fatigue, quality of life, lymphedema, pain, mood and fall risk.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016011426008N1
Registration date: 2016-07-28, 1395/05/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-28, 1395/05/07
Registrant information
Name
bahare mahmudieh
Name of organization / entity
university of tehran
Country
Iran (Islamic Republic of)
Phone
+98 76 4443 2933
Email address
baharemahmudieh@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-05-18, 1394/02/28
Expected recruitment end date
2015-07-21, 1394/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trail of effect of exercise (resistance-core stability) on muscle strength, balance and core stability in women with breast cancer and healthy women
Public title
The effect of exercise in women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Aged 29 to 60 years; Diagnosed with breast cancer stage I to III; Mastectomy in at least the last 12 months; Course of radiation-therapy and chemotherapy are completed; No new rehabilitation in upper and lower body (6 months before the diagnosis of breast cancer); No any type of breast reconstruction; Without regular exercise or less than 2 sessions training per week in the last 6 months. Exclusion criteria: No participation in the Post-test or no continue exercise program; No participation in two consecutive sessions or 3 non-consecutive sessions; Injury, onset or increased pain during exercise; Disease recurrence.
Age
From 29 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University of Tehran
Street address
Kish International Campus, Univesity of Tehran, Mirmohanna Boulevard, Kish Island, Iran
City
kish Island
Postal code
55665-79416
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
4023085

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified

Primary outcomes

1

Description
Upper extremity muscle strength
Timepoint
Before and 6 weeks after intervention
Method of measurement
Muscle strength in shoulder abduction, shoulder flexion and shoulder external rotation with hand-held dynamometry (Lafayette Manual Muscle Test System)

2

Description
Central Stability (Trunk Muscle Endurance)
Timepoint
Before and 6 weeks after intervention
Method of measurement
Core Stability Tests (Beiring-Sorensen Test, McGill Test, Trunk Flexion Test)

3

Description
Static balance
Timepoint
Before and 6 weeks after intervention
Method of measurement
Functional tests in Static balance: Single Leg, Balance Error Scoring System.

4

Description
Dynamic balance
Timepoint
Before and 6 weeks after intervention
Method of measurement
Functional tests in dynamic balance: Four Square Step Test, Timed 360° Turn, Timed Up & Go.

5

Description
Lower extremity muscle strength
Timepoint
Before and 6 weeks after intervention
Method of measurement
Muscle strength in hip abduction, hip flexion and knee extension with hand-held dynamometry (Lafayette Manual Muscle Test System)

Secondary outcomes

1

Description
Arm Lymphedema
Timepoint
Before and 6 weeks after intervention
Method of measurement
Forearm circumference measurements

2

Description
Shoulder girdle function
Timepoint
Before and 6 weeks after intervention
Method of measurement
Disability of arm, shoulder and hand (Dash) Questionare

3

Description
Fear of falling
Timepoint
Before and 6 weeks after intervention
Method of measurement
Fall Efficacy ScaleInternational (FES-I)

4

Description
Profile of Mood States
Timepoint
Before and 6 weeks after intervention
Method of measurement
Profile of Mood State questionnaire (POMS)

5

Description
Fatigue
Timepoint
Before and 6 weeks after intervention
Method of measurement
Piper questionnaire

6

Description
Quality of Life
Timepoint
Before and 6 weeks after intervention
Method of measurement
National Medical Center and Beckman Research Institute

Intervention groups

1

Description
In the supervised resistance intervention group, exercise protocol was consisted of resistance training (upper body, lower body). Supervised intervention was included bench press, shoulder press, rowing, pull down, biceps curl, triceps extension, Leg curl, Leg extension, Leg press, Lange, calf strengthening, abductions and Adduction hip. Intervention was performed for 6 weeks, 3 sessions a week and each session lasts up to 1.5 hours. Each session included 10 minutes warm up and 5 minutes cool down.
Category
Other

2

Description
In the home-based intervention group resistance, exercise protocol was consisted of resistance training (upper body, lower body). Unsupervised Intervention was included bench press, shoulder press, rowing, pull down, biceps curl, triceps extension, Leg curl, Leg extension, Leg press, Lange, calf strengthening, abductions and Adduction hip. Intervention was performed for 6 weeks, 3 sessions a week and each session lasts up to 1.5 hours. Each session included 10 minutes warm up and 5 minutes cool down.
Category
Other

3

Description
In the combination exercise, intervention group, combination of selected resistance training and balance and core stability training under the supervision of an experienced that was done. Intervention was performed for 6 weeks, 3 sessions a week and each session lasts up to 1.5 hours. Each session included 10 minutes warm up and 5 minutes cool down.
Category
Other

4

Description
The patients and healthy control groups had their daily activities and did not participate in any exercise program during the intervention period.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
ُSeyedoshohada Hospital in Isfahan
Full name of responsible person
Doctor Hamid Emami
Street address
Seyedoshohada Hospital, Pole Shiri Street, Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kish International Campus University of Tehran
Full name of responsible person
Reza Nuri
Street address
Kish International Campus, University of Tehran, Mirmohanna Boulevard, Kish Island, Iran
City
Kish Island
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kish International Campus 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
Bahare Mahmudieh
Position
Phd Candidate
Other areas of specialty/work
Street address
Kish International Campus, University of Tehran, Mirmohanna Boulevard, Kish Island, Iran
City
Kish
Postal code
79416-55665
Phone
+98 76 4443 0055
Fax
+98 76 4443 2934
Email
baharemahmudieh@ut.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Bahare Mahmudieh
Position
Phd Candiate
Other areas of specialty/work
Street address
Kish International Campus, University of Tehran, Mirmohanna Boulevard, Kish Island, Iran
City
Kish
Postal code
79416-55665
Phone
+98 76 4443 0055
Fax
+98 76 4443 2934
Email
baharemahmudieh@ut.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Bahare Mahmudieh
Position
Phd Candidate
Other areas of specialty/work
Street address
Kish International Campus, University of Tehran, Mirmohanna Boulevard, Kish Island, Iran
City
Kish
Postal code
79416-55665
Phone
+98 76 4443 0055
Fax
+98 76 4443 2934
Email
baharemahmudieh@ut.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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