Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04760145
Status:
UNKNOWN
Last Update Posted:
2021-02-18
First Post:
2021-02-15
Brief Title:
EFFECT OF FLOW RESTRICTION ON BONE QUALITY WITHIN A MULTICOMPONENT EXERCISE PROGRAM FOR OLDER WOMEN WITH OSTEOPOROSIS
Sponsor:
Universitat Internacional de Catalunya
Organization:
Universitat Internacional de Catalunya
Study Overview
Official Title:
EFFECT OF FLOW RESTRICTION ON BONE QUALITY WITHIN A MULTICOMPONENT EXERCISE PROGRAM FOR OLDER WOMEN WITH OSTEOPOROSIS SINGLE-BLIND CLINICAL TRIAL
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HYPOTHESIS
- A multicomponent exercise program where strength exercises are performed with blood flow restriction obtains better values in densitometry and bone mass of osteoporotic patients with respect to the same multicomponent exercise program where strength is worked without flow restriction
INTERVENTION
The recruitment of the population will be carried out between July and November 2021 with the collaboration of the Consorci Sanitari de Terrassa CST which brings together a hospital center and different primary care centers CAP The primary care physicians and rheumatologists of the CST will receive an e-mail from the hospital management informing them of the study to be carried out so that if they consider it appropriate they can inform their patients
Intervention of the intervention and control group
Each volunteer will be assigned to an intervention group either to the control group CG or experimental group EG
The control group and intervention group will receive the same multicomponent exercise program based on specific literature for being an effective safe and feasible training for both elderly people 2091 Bouaziz Walid 2016 2092 FragalaM S 2019 with or without frailty 2093 Cadore Eduardo L 2014 2094 Casas-Herrero Alvaro 2019 2088 Fernández-García Ángel Iván 2020 andor with osteoporosis 2089 Moradell Ana 2020 The main difference between both groups is that the experimental group EG will perform the strength exercises with flow restriction BFR while the control group CG will not have any restriction
The periodicity of both groups will be 2 sessions per week with a duration of 65 minutes per session and the duration of the intervention of 6 months and a follow-up 12 months after the beginning of the intervention see scheme
The training will be supervised at all times by a physiotherapist with more than 10 years of experience in multicomponent exercise The sessions will include both limb and trunk work and will have a clear functional objective focusing on activities of daily living ADL Each session will work on all the basic physical abilities strength balance endurance flexibility and coordination and will be divided into
10 minutes of initial warm-up This is divided into 8 minutes walking on a treadmill or cyclohergometer with an intensity corresponding to 30 of heart rate reserve Followed by 2 minutes of active mobilizations in both upper and lower extremities
20 minutes of strength exercises These will be interspersed with the rest of the exercises and will include the different extremities and trunk During the first month training will be carried out with loads corresponding to 20 of 1 repetition maximum RM and from the second month onwards it will be increased to 30-35 of 1 RM
10 minutes of resistance exercises These exercises will be interspersed with the rest to make the session much more enjoyable
10 minutes of coordination and balance exercises These exercises will be interspersed with the rest of the activities
5 minutes of flexibility These exercises will be performed interspersed with the strength and endurance exercises
5 minutes of return to calm and relaxation To facilitate the monitoring of the researcher who will apply the intervention each group will be subdivided into smaller groups ratio of 5 subjects per researcher
- A multicomponent exercise program where strength exercises are performed with blood flow restriction obtains better values in densitometry and bone mass of osteoporotic patients with respect to the same multicomponent exercise program where strength is worked without flow restriction
INTERVENTION
The recruitment of the population will be carried out between July and November 2021 with the collaboration of the Consorci Sanitari de Terrassa CST which brings together a hospital center and different primary care centers CAP The primary care physicians and rheumatologists of the CST will receive an e-mail from the hospital management informing them of the study to be carried out so that if they consider it appropriate they can inform their patients
Intervention of the intervention and control group
Each volunteer will be assigned to an intervention group either to the control group CG or experimental group EG
The control group and intervention group will receive the same multicomponent exercise program based on specific literature for being an effective safe and feasible training for both elderly people 2091 Bouaziz Walid 2016 2092 FragalaM S 2019 with or without frailty 2093 Cadore Eduardo L 2014 2094 Casas-Herrero Alvaro 2019 2088 Fernández-García Ángel Iván 2020 andor with osteoporosis 2089 Moradell Ana 2020 The main difference between both groups is that the experimental group EG will perform the strength exercises with flow restriction BFR while the control group CG will not have any restriction
The periodicity of both groups will be 2 sessions per week with a duration of 65 minutes per session and the duration of the intervention of 6 months and a follow-up 12 months after the beginning of the intervention see scheme
The training will be supervised at all times by a physiotherapist with more than 10 years of experience in multicomponent exercise The sessions will include both limb and trunk work and will have a clear functional objective focusing on activities of daily living ADL Each session will work on all the basic physical abilities strength balance endurance flexibility and coordination and will be divided into
10 minutes of initial warm-up This is divided into 8 minutes walking on a treadmill or cyclohergometer with an intensity corresponding to 30 of heart rate reserve Followed by 2 minutes of active mobilizations in both upper and lower extremities
20 minutes of strength exercises These will be interspersed with the rest of the exercises and will include the different extremities and trunk During the first month training will be carried out with loads corresponding to 20 of 1 repetition maximum RM and from the second month onwards it will be increased to 30-35 of 1 RM
10 minutes of resistance exercises These exercises will be interspersed with the rest to make the session much more enjoyable
10 minutes of coordination and balance exercises These exercises will be interspersed with the rest of the activities
5 minutes of flexibility These exercises will be performed interspersed with the strength and endurance exercises
5 minutes of return to calm and relaxation To facilitate the monitoring of the researcher who will apply the intervention each group will be subdivided into smaller groups ratio of 5 subjects per researcher
Detailed Description:
BACKGROUND
According to the WHO osteoporosis is a disorder of the skeleton characterized by impaired bone strength primarily reflecting poor integration of bone density and quality 2042 NIH Consensus Development Panel on Osteoporosis Prevention Diagnosis and Therapy 2001 There are two types of osteoporosis the most common is considered primary or idiopathic and includes juvenile postmenopausal and senile osteoporosis Secondary osteoporosis is considered to be that in which the deterioration of bone quality is due to different types of systemic diseases or produced by the intake of certain drugs mainly glucocorticoids anticoagulants and diuretics 2164 Maggi S 2006 Primary osteoporosis can affect both sexes but postmenopausal and older women are more vulnerable to this disease because they possess important risk factors such as the same age and estrogen depletion 2043 Tella Sri Harsha 2014
It is estimated that approximately 200 million women worldwide have osteoporosis approximately 10 of women in their 60s 20 of women in their 70s 40 of women in their 80s and 67 of women in their 90s 2044 Kanis John Anthony 2007 Double beam X-ray densitometry DEXA is the test to accurately determine bone mass 2046 Curiel M Diaz 19972045 PerisP 2000 and osteoporosis is considered to be present when densitometry values are below 25 standard deviations SD of peak bone mass 2081 Kanis John A 1994 the maximum value reached in young women
The reduced mass and altered microstructure of osteoporotic bone leads to increased bone fragility and an increased risk of bone fracture 2047 Anonymous 1993 2048 Norohna Judith A 2020 It is estimated that an osteoporotic fracture occurs every 3 seconds and 89 million such fractures are considered to occur worldwide 2049 Ribagin Simeon 2016 accounting in the European continent for 175 of noncommunicable diseases 2051 Johnell Olof 2006 Fragility fractures are estimated to be associated with significant morbidity and mortality Johnell and Kanis estimated that 740000 deaths per year are associated with hip fracture due to osteoporosis 2052 Johnell Olof 2004 Despite advances in therapeutic procedures only 30-45 of those who survive a hip fracture recover pre-fracture function and 32-80 suffer some form of dysfunction 2142 Rey-RodriguezMM 2020 2144 Takahashi Ai 2020 thus representing a high economic and life cost for the countries that suffer from them It is estimated that in 2050 the United States will spend 1315 billion to treat fractures caused by osteoporosis 2053 Burge Russel 2007
Associated with osteoporosis numerous investigations have observed a correlation between altered bone quality osteopenia or osteoporosis and a decrease in strength andor muscle mass sarcopenia thus increasing the frailty and deterioration of the patient suffering from it 2054 Hirschfeld HP 2017 2055 Hassan Ebrahim Bani 2017 2056 Paintin James 2018 2056 Paintin James 2018 Tokeshi et al observed how patients with osteoporotic fracture had lower muscle mass compared to those patients without osteoporisis 2057 Tokeshi Soichiro 2020 Hoo Lee and Sik Gong describe that lower extremity muscle mass and loss of grip are closely related to the occurrence of osteoporotic vertebral fracture 2058 Eguchi Yawara 2019 and numerous investigations show the relationship between grip strength and osteoporotic fractures in older elderly 2059 Kärkkäinen M 2008 2060 Denk Katharina 2018 2061 Kamiya Kuniyasu 2019 2062 Samelson Elizabeth J 2006 2062 Samelson Elizabeth J 2006
Because of the morbidity increased associated frailty and high economic cost associated with osteoporosis different therapeutic strategies have been proposed Although the number of patients treated with pharmacology has been increasing in recent years 2166 de FelipeR 2010 and treatment recommended in most clinical guidelines 2167 Sanfélix-Genovés José 20142165 Tarantino 2017 more global approaches such as exercise andor nutrition are increasingly gaining importance 2165 Tarantino 2017 2168 JangHD 2020
HYPOTHESIS
- A multicomponent exercise program where strength exercises are performed with blood flow restriction obtains better values in densitometry and bone mass of osteoporotic patients with respect to the same multicomponent exercise program where strength is worked without flow restriction
INTERVENTION
The recruitment of the population will be carried out between July and November 2021 with the collaboration of the Consorci Sanitari de Terrassa CST which brings together a hospital center and different primary care centers CAP The primary care physicians and rheumatologists of the CST will receive an e-mail from the hospital management informing them of the study to be carried out so that if they consider it appropriate they can inform their patients
Intervention of the intervention and control group
Each volunteer will be assigned to an intervention group either to the control group CG or experimental group EG
The control group and intervention group will receive the same multicomponent exercise program based on specific literature for being an effective safe and feasible training for both elderly people 2091 Bouaziz Walid 2016 2092 FragalaM S 2019 with or without frailty 2093 Cadore Eduardo L 2014 2094 Casas-Herrero Alvaro 2019 2088 Fernández-García Ángel Iván 2020 andor with osteoporosis 2089 Moradell Ana 2020 The main difference between both groups is that the experimental group EG will perform the strength exercises with flow restriction BFR while the control group CG will not have any restriction
The periodicity of both groups will be 2 sessions per week with a duration of 65 minutes per session and the duration of the intervention of 6 months and a follow-up 12 months after the beginning of the intervention see scheme
The training will be supervised at all times by a physiotherapist with more than 10 years of experience in multicomponent exercise The sessions will include both limb and trunk work and will have a clear functional objective focusing on activities of daily living ADL Each session will work on all the basic physical abilities strength balance endurance flexibility and coordination and will be divided into
10 minutes of initial warm-up This is divided into 8 minutes walking on a treadmill or cyclohergometer with an intensity corresponding to 30 of heart rate reserve Followed by 2 minutes of active mobilizations in both upper and lower extremities
20 minutes of strength exercises These will be interspersed with the rest of the exercises and will include the different extremities and trunk During the first month training will be carried out with loads corresponding to 20 of 1 repetition maximum RM and from the second month onwards it will be increased to 30-35 of 1 RM
10 minutes of resistance exercises These exercises will be interspersed with the rest to make the session much more enjoyable
10 minutes of coordination and balance exercises These exercises will be interspersed with the rest of the activities
5 minutes of flexibility These exercises will be performed interspersed with the strength and endurance exercises
5 minutes of return to calm and relaxation To facilitate the monitoring of the researcher who will apply the intervention each group will be subdivided into smaller groups ratio of 5 subjects per researcher
According to the WHO osteoporosis is a disorder of the skeleton characterized by impaired bone strength primarily reflecting poor integration of bone density and quality 2042 NIH Consensus Development Panel on Osteoporosis Prevention Diagnosis and Therapy 2001 There are two types of osteoporosis the most common is considered primary or idiopathic and includes juvenile postmenopausal and senile osteoporosis Secondary osteoporosis is considered to be that in which the deterioration of bone quality is due to different types of systemic diseases or produced by the intake of certain drugs mainly glucocorticoids anticoagulants and diuretics 2164 Maggi S 2006 Primary osteoporosis can affect both sexes but postmenopausal and older women are more vulnerable to this disease because they possess important risk factors such as the same age and estrogen depletion 2043 Tella Sri Harsha 2014
It is estimated that approximately 200 million women worldwide have osteoporosis approximately 10 of women in their 60s 20 of women in their 70s 40 of women in their 80s and 67 of women in their 90s 2044 Kanis John Anthony 2007 Double beam X-ray densitometry DEXA is the test to accurately determine bone mass 2046 Curiel M Diaz 19972045 PerisP 2000 and osteoporosis is considered to be present when densitometry values are below 25 standard deviations SD of peak bone mass 2081 Kanis John A 1994 the maximum value reached in young women
The reduced mass and altered microstructure of osteoporotic bone leads to increased bone fragility and an increased risk of bone fracture 2047 Anonymous 1993 2048 Norohna Judith A 2020 It is estimated that an osteoporotic fracture occurs every 3 seconds and 89 million such fractures are considered to occur worldwide 2049 Ribagin Simeon 2016 accounting in the European continent for 175 of noncommunicable diseases 2051 Johnell Olof 2006 Fragility fractures are estimated to be associated with significant morbidity and mortality Johnell and Kanis estimated that 740000 deaths per year are associated with hip fracture due to osteoporosis 2052 Johnell Olof 2004 Despite advances in therapeutic procedures only 30-45 of those who survive a hip fracture recover pre-fracture function and 32-80 suffer some form of dysfunction 2142 Rey-RodriguezMM 2020 2144 Takahashi Ai 2020 thus representing a high economic and life cost for the countries that suffer from them It is estimated that in 2050 the United States will spend 1315 billion to treat fractures caused by osteoporosis 2053 Burge Russel 2007
Associated with osteoporosis numerous investigations have observed a correlation between altered bone quality osteopenia or osteoporosis and a decrease in strength andor muscle mass sarcopenia thus increasing the frailty and deterioration of the patient suffering from it 2054 Hirschfeld HP 2017 2055 Hassan Ebrahim Bani 2017 2056 Paintin James 2018 2056 Paintin James 2018 Tokeshi et al observed how patients with osteoporotic fracture had lower muscle mass compared to those patients without osteoporisis 2057 Tokeshi Soichiro 2020 Hoo Lee and Sik Gong describe that lower extremity muscle mass and loss of grip are closely related to the occurrence of osteoporotic vertebral fracture 2058 Eguchi Yawara 2019 and numerous investigations show the relationship between grip strength and osteoporotic fractures in older elderly 2059 Kärkkäinen M 2008 2060 Denk Katharina 2018 2061 Kamiya Kuniyasu 2019 2062 Samelson Elizabeth J 2006 2062 Samelson Elizabeth J 2006
Because of the morbidity increased associated frailty and high economic cost associated with osteoporosis different therapeutic strategies have been proposed Although the number of patients treated with pharmacology has been increasing in recent years 2166 de FelipeR 2010 and treatment recommended in most clinical guidelines 2167 Sanfélix-Genovés José 20142165 Tarantino 2017 more global approaches such as exercise andor nutrition are increasingly gaining importance 2165 Tarantino 2017 2168 JangHD 2020
HYPOTHESIS
- A multicomponent exercise program where strength exercises are performed with blood flow restriction obtains better values in densitometry and bone mass of osteoporotic patients with respect to the same multicomponent exercise program where strength is worked without flow restriction
INTERVENTION
The recruitment of the population will be carried out between July and November 2021 with the collaboration of the Consorci Sanitari de Terrassa CST which brings together a hospital center and different primary care centers CAP The primary care physicians and rheumatologists of the CST will receive an e-mail from the hospital management informing them of the study to be carried out so that if they consider it appropriate they can inform their patients
Intervention of the intervention and control group
Each volunteer will be assigned to an intervention group either to the control group CG or experimental group EG
The control group and intervention group will receive the same multicomponent exercise program based on specific literature for being an effective safe and feasible training for both elderly people 2091 Bouaziz Walid 2016 2092 FragalaM S 2019 with or without frailty 2093 Cadore Eduardo L 2014 2094 Casas-Herrero Alvaro 2019 2088 Fernández-García Ángel Iván 2020 andor with osteoporosis 2089 Moradell Ana 2020 The main difference between both groups is that the experimental group EG will perform the strength exercises with flow restriction BFR while the control group CG will not have any restriction
The periodicity of both groups will be 2 sessions per week with a duration of 65 minutes per session and the duration of the intervention of 6 months and a follow-up 12 months after the beginning of the intervention see scheme
The training will be supervised at all times by a physiotherapist with more than 10 years of experience in multicomponent exercise The sessions will include both limb and trunk work and will have a clear functional objective focusing on activities of daily living ADL Each session will work on all the basic physical abilities strength balance endurance flexibility and coordination and will be divided into
10 minutes of initial warm-up This is divided into 8 minutes walking on a treadmill or cyclohergometer with an intensity corresponding to 30 of heart rate reserve Followed by 2 minutes of active mobilizations in both upper and lower extremities
20 minutes of strength exercises These will be interspersed with the rest of the exercises and will include the different extremities and trunk During the first month training will be carried out with loads corresponding to 20 of 1 repetition maximum RM and from the second month onwards it will be increased to 30-35 of 1 RM
10 minutes of resistance exercises These exercises will be interspersed with the rest to make the session much more enjoyable
10 minutes of coordination and balance exercises These exercises will be interspersed with the rest of the activities
5 minutes of flexibility These exercises will be performed interspersed with the strength and endurance exercises
5 minutes of return to calm and relaxation To facilitate the monitoring of the researcher who will apply the intervention each group will be subdivided into smaller groups ratio of 5 subjects per researcher
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None