Influence of Exercise Program on Serum Matrix Metalloproteinases and Functional Status in Women With Postmenopausal Osteoporosis
Condition: Influence of Specifically Designed Exercise Program on Serum Matrix Metalloproteinases and Functional Status in Women With Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional

Summary: 
      Osteoporosis is a chronic, systemic and the most frequently metabolic bone disease,
      characterized by low bone mass and microarchitectural remodeling of bone, which results in a
      greater fragility of the bone and risk of fracture. With the purpose of explaining the
      patophysiological mechanisms responsible for osteoporosis, it is necessary to determine the
      factors that influence on the activity and differentiation of osteoblasts and osteoclasts, as
      well as their dynamic change depending on the use of an appropriate treatment.

      According to the recommendations of the International Association for osteoporosis (the
      National Osteoporosis Fondation- NOF) the treatment of osteoporosis includes pharmacological
      and non-pharmacological treatment of. Pharmacological includes a range of different drug,
      where the bisphosphonates, non-hormonal antiresorptive drugs, present gold standard in the
      treatment of postmenopausal osteoporosis . Non-pharmacological treatment implies the daily
      physical activity and the specific exercise program, for the purpose of slowing or stopping
      the loss of bone mass, improve balance, and reduce the risk of falling and fractures.

      It is known that the mechanical loading of the bone has to be strong enough to achieve the
      effect of osteogenesis. The load due to the long bones of gravity and the tension force
      produced by the muscular activity, are the natural stimulus for maintenance of bone mass and
      muscle strength. This can be achieved by practice involving the activities in which the net
      mass of the body constitutes an additional load (so-called. "Weight-bearing exercises"), as
      well as exercise resistance from.

      Exercise with one's own mass include actions to counter gravity in an upright standing
      position, and then may be a stronger (high-impact) collides with the substrate (e.g.,
      jumping) and the lower (low-impact) collides with the substrate (e.g., walking). Aerobic
      exercise, especially walking, is the most common type of intervention because of the ease
      administration and safety.

      Resistance training is another effective type of exercises that can affect the maintenance or
      improvement of bone mineral density, with the most frequently applied with the combination of
      the dynamic resistance exercises that engage multiple joints, large groups of muscles, and
      the burden on the hips and the spine. In order to strength training, with the aim of
      maintaining and stimulating bone mineral density had the best effect, it is necessary to
      include the basic principles of specificity, load and progression. Training should be
      directed to the adaptation of a specific part of the body, should be sufficiently intense to
      and beyond the common load, and a variety of progressive enough. Progression loads should be
      slow and gradual to avoid injury. We assumed that this type of exercise can be achieved by
      changing the activity of serum matrix metalloproteinases.

      It has been proven that in the process of remodeling of the extracellular matrix of the bone,
      matrix-metalloproteinases play an important role, both, the occurrence of bone as well as in
      pathological processes of bone resorption . Also, it is known that metalloproteinases,
      particularly the MMP-2 and MMP-9 play a significant role in the development of skeletal
      muscle recovery from injury or remodeling of the same after exercise.Taking into account the
      results of the latest studies on the role of metalloproteinases in the development and
      remodeling of bone, also and muscle, we assumed that the value of metalloproteinases could
      serve as markers for early assessment of treatment response of patients with osteoporosis. In
      our study, we will follow the changes of serum levels of metalloproteinases as well as tissue
      inhibitor of matrix metalloproteinases 1 (TIMP-1) in the serum of patients with
      postmenopausal osteoporosis, which have prescribed bisphosphonates, before and after
      application to the specifically designed exercise program . A functional genetic
      polymorphisms (PM), by modulating the expression of the MMP can be associated with a
      differential response to the application of our patients of the same exercise program.
      Specifically designed exercise program in patients with osteoporosis, which affects the
      increase in BMD and muscle strength, can be associated with a specific MMP genotyp . In our
      research we will follow the influence of polymorphisms of the mentioned metalloproteinases on
      the efficacy of the treatment (the specifically designed exercise program ) in patients with
      postmenopausal osteoporosis.
    

Detailed description: 
      Osteoporosis is a chronic, systemic and the most frequently metabolic bone disease,
      characterized by low bone mass and microarchitectural remodeling of bone, which results in a
      greater fragility of the bone and risk of fracture. With the purpose of explaining the
      patophysiological mechanisms responsible for osteoporosis, it is necessary to determine the
      factors that influence on the activity and differentiation of osteoblasts and osteoclasts, as
      well as their dynamic change depending on the use of an appropriate treatment.

      According to the recommendations of the International Association for osteoporosis (the
      National Osteoporosis Fondation- NOF) the treatment of osteoporosis includes pharmacological
      and non-pharmacological treatment of. Pharmacological includes a range of different drug,
      where the bisphosphonates, non-hormonal antiresorptive drugs, present gold standard in the
      treatment of postmenopausal osteoporosis . Non-pharmacological treatment implies the daily
      physical activity and the specific exercise program, for the purpose of slowing or stopping
      the loss of bone mass, improve balance, and reduce the risk of falling and fractures.

      It is known that the mechanical loading of the bone has to be strong enough to achieve the
      effect of osteogenesis. The load due to the long bones of gravity and the tension force
      produced by the muscular activity, are the natural stimulus for maintenance of bone mass and
      muscle strength. This can be achieved by practice involving the activities in which the net
      mass of the body constitutes an additional load (so-called. "Weight-bearing exercises"), as
      well as exercise resistance from.

      Exercise with one's own mass include actions to counter gravity in an upright standing
      position, and then may be a stronger (high-impact) collides with the substrate (e.g.,
      jumping) and the lower (low-impact) collides with the substrate (e.g., walking). Aerobic
      exercise, especially walking, is the most common type of intervention because of the ease
      administration and safety.

      Resistance training is another effective type of exercises that can affect the maintenance or
      improvement of bone mineral density, with the most frequently applied with the combination of
      the dynamic resistance exercises that engage multiple joints, large groups of muscles, and
      the burden on the hips and the spine. In order to strength training, with the aim of
      maintaining and stimulating bone mineral density had the best effect, it is necessary to
      include the basic principles of specificity, load and progression. Training should be
      directed to the adaptation of a specific part of the body, should be sufficiently intense to
      and beyond the common load, and a variety of progressive enough. Progression loads should be
      slow and gradual to avoid injury. We assumed that this type of exercise can be achieved by
      changing the activity of serum matrix metalloproteinases.

      It has been proven that in the process of remodeling of the extracellular matrix of the bone,
      matrix-metalloproteinases play an important role, both, the occurrence of bone as well as in
      pathological processes of bone resorption . Also, it is known that metalloproteinases,
      particularly the MMP-2 and MMP-9 play a significant role in the development of skeletal
      muscle recovery from injury or remodeling of the same after exercise.Taking into account the
      results of the latest studies on the role of metalloproteinases in the development and
      remodeling of bone, also and muscle, we assumed that the value of metalloproteinases could
      serve as markers for early assessment of treatment response of patients with osteoporosis. In
      our study, we will follow the changes of serum levels of metalloproteinases as well as tissue
      inhibitor of matrix metalloproteinases 1 (TIMP-1) in the serum of patients with
      postmenopausal osteoporosis, which have prescribed bisphosphonates, before and after
      application to the specifically designed exercise program . A functional genetic
      polymorphisms (PM), by modulating the expression of the MMP can be associated with a
      differential response to the application of our patients of the same exercise program.
      Specifically designed exercise program in patients with osteoporosis, which affects the
      increase in BMD and muscle strength, can be associated with a specific MMP genotyp . In our
      research we will follow the influence of polymorphisms of the mentioned metalloproteinases on
      the efficacy of the treatment (the specifically designed exercise program ) in patients with
      postmenopausal osteoporosis.
    

Intervention name(s): exercises
Intervention type(s): Other
Intervention description(s): Aerobic exercise will be conducted as a dose walk, 3-5 km / h, lasting 50 minutes per day, least five days per week, for 12 weeks. The intensity of the training will be around 70% of the maximal heart rate.
Resistance training and balance exercises will be conducted as a group program and will involve exercises to strengthen the muscles of the upper and lower extremities and balance exercises. The intensity of the training will be increased on weekly, starting from 3-5 repeating load and its own weight, up to 8-12 repetitions and load straps. Progression and maintenance load tapes will be carried out depending on the capacity of individualized persons. Frequency of training will be 3 times a week,will last 70 minutes per day for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment