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The Effect of 6 Weeks Resistance Training and Combined Resistance Training with Pulsed Electromagnetic Stimulation on bone biomarkers and Balance in Severe Haemophilia A with Osteoporosis

Protocol summary

Summary
This study was aimed to investigate the effects of a short-term resistance training program and pulsed electromagnetic fields) PEMFs( on bone metabolism, balance, joint function, and quality of life in sever hemophilia A with osteoporosis. Forty-three severe haemophilia A with osteoporosis were randomly assigned to resistance training (RT), combined resistance training with PEMFs (RTPEMF), PEMFs, and control groups. The RT and RTPEMF groups performed progressive resistance exercises (50-60% 1RM); in RTPEMF, the lower repetition of exercises was compensated with 30-min exposure to PEMFs. The PEMF group was exposed to 60 min of PEMFs (30 Hz and 40 Gauss).The intervention was performed 3 days weekly for 6 weeks. Bone-specific alkaline phosphatase (BALP), N-terminal telopeptide of type 1 collagen (NTX), joint function, balance, and quality of life were assessed before and after the program. After 6 weeks, joint physical conditions, balance performance and quality of life showed significant improvement in RT and RTPEMF groups. BALP increased significantly in RT and RTPEMF groups. No groups showed significant changes in NTX. The best pain relief occurred in the knee joint of the RT group. Resistance training can increase bone metabolism and improve balance performance, joint physical condition muscle strength, and quality of life in severe haemophilia A with osteoporosis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201010174952N1
Registration date: 2013-04-24, 1392/02/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-04-24, 1392/02/04
Registrant information
Name
Giti Torkaman
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4509
Email address
torkamg@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares university
Expected recruitment start date
2010-10-22, 1389/07/30
Expected recruitment end date
2011-11-21, 1390/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 6 Weeks Resistance Training and Combined Resistance Training with Pulsed Electromagnetic Stimulation on bone biomarkers and Balance in Severe Haemophilia A with Osteoporosis
Public title
resistance training and electromagnetic fields in osteoporosis
Purpose
Treatment
Inclusion/Exclusion criteria
Include Criteria: sever hemophilia-A; T score less than 2.5. Exclude Criteria: no history of hepatitis B and C; no HRT in the last 6 months; no acute target joint, no history of inhibitors.
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 43
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tarbiat modares university
Street address
ale-ahmad Ave.
City
tehran
Postal code
1411713116
Approval date
2010-10-08, 1389/07/16
Ethics committee reference number
52/99424

2

Ethics committee
Name of ethics committee
Tarbiat modares university
Street address
ale-ahmad Ave.
City
tehran
Postal code
1411713116
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
52/99424

Health conditions studied

1

Description of health condition studied
hemophilia with osteoporosis
ICD-10 code
M82.8
ICD-10 code description
Osteoporosis in other diseases classified elsewhere

Primary outcomes

1

Description
NTX
Timepoint
Before and 6 weeks after intervention
Method of measurement
ELISA Kit

2

Description
CTX
Timepoint
Before and 6 weeks after intervention
Method of measurement
ELISA Kit

3

Description
Balance and Strength
Timepoint
Before and 6 weeks after intervention
Method of measurement
physical assesment and observation

4

Description
Quality of Life
Timepoint
Before and 6 weeks after intervention
Method of measurement
Quesstionaire

Secondary outcomes

1

Description
joint range of motion
Timepoint
Before and 6 weeks after intervention
Method of measurement
goniameter

2

Description
joint swelling
Timepoint
Before and 6 weeks after intervention
Method of measurement
physical assesment

Intervention groups

1

Description
6-week trunk, upper and lower limb progressive resistance training; 3 days in week; 50-60% 1repeated maximum; 2 sets of 10-15 repetition
Category
Rehabilitation

2

Description
6-week trunk, upper and lower limb progressive resistance training; 3 days in week; 50-60% 1repeated maximum; 2 sets of 5-10 repetition and 30 min electromagnetic fields with frequency of 30 Hz and intensity of 40 Gauss
Category
Rehabilitation

3

Description
Control
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
seydalshohada hospital
Full name of responsible person
Street address
City
Esfehan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
tarbiat modares university
Full name of responsible person
Dr Yaghoob Fathollahi
Street address
Vice-Chancellor for Reaserch Affairs,Tarbiat Modares University,Ale-Ahmad Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
tarbiat modares university
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
Tarbiat Modares University
Full name of responsible person
Giti Torkaman
Position
Professor(PhD)/ Supervisor
Other areas of specialty/work
Street address
Physical Therapy Department, Faculty of Medical Sciences, Tarbiat Modares University, Ale-Ahmad Ave.
City
Tehran
Postal code
Phone
+98 21 8288 4509
Fax
Email
torkamg@modares.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Giti Torkaman
Position
PhD
Other areas of specialty/work
Street address
Physical Therapy Department, Faculty of Medical Sciences, Tarbiat Modares University, Ale-Ahmad Ave.
City
Tehran
Postal code
Phone
+98 21 8288 4509
Fax
Email
torkamg@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
tarbiat modares university
Full name of responsible person
giti torkaman
Position
Professor
Other areas of specialty/work
Street address
Physical Therapy Department, Faculty of Medical Sciences, Tarbiat Modares University, Ale-Ahmad Ave.
City
Tehran
Postal code
1411713116
Phone
+98 21 8288 4509
Fax
Email
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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