Osteoporosis
Conditions
Interventions
The protocol is for a randomized controlled clinical trial with a sample of older women with osteoporosis, number of samples is equal to 72, divided into 3 groups: 1) a Control Group (CG, number of sa
2) a Vitamin D and Calcium Group (VDCaG, number of samples is equal to 24), using vitamin D and calcium supplementation, according to medical prescription established for the present study
and 3) a Vitamin D and Calcium Croup combined with a Multicomponent Exercise Program (VDCaMEP), number of samples is equal to 24, using vitamin D plus calcium supplementation as prescribed for the pre
weight-bearin
G11.427.410.698.277
Sponsors
Complexo Hospital de Clínicas da Universidade Federal do Paraná
Universidade Federal do Paraná
Eligibility
Sex/Gender
Female
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: Elderly women; 65 years of age or above on the day of the initial assessments; resident in Curitiba-PR-Brazil; with a diagnosis of osteoporosis by dual energy x-ray (DEXA); able to walk independently a 8 meter flat course, with or without any assistive equipment; presenting a cognitive score in accordance with the Mini Mental state (score 24) regarding the presence or absence of prior formal schooling; not having neurological diseases and/or orthopedic traumas that may prevent the evaluation and exercises execution; not having severe deficiencies (cardiac, respiratory, hepatic, renal, and decompensated hypertension Blood pressure (140 and 90 mmHg); not having any neurologic or trauma-orthopedic diseases with fixations or prostheses with metallic or non-metallic implants, which may prevent the performance of the proposed evaluations or exercises; not having had prior history of upper extremities and Lower Extremity and or spine fracture in the last 4 months or that may impair their performance in the proposed evaluations and exercises; Visual assessment by the Snellen card presenting (score 20 and 70 unilateral), in case of visual impairment, an adequate corrective instrument should be used (glasses or lenses); not having been involved in any regular resistance exercise program in the last 6 months.
Exclusion criteria
Exclusion criteria: Previous history of fractures of the upper and lower limbs and or spine in the last 4 months; presenting metabolic instability or decompensated cardiovascular disease; having inflammatory and or autoimmune diseases, acute or terminal disease; cancer. Present neurological diseases; osteomalacia; presenting unstable or exercise-induced angina pectoris or myocardial ischemia; presenting type 1 diabetes mellitus; presenting previous diagnosis of: hypercalciuria, hyperparathyroidism, desabsorptive syndromes; using anabolic steroids (for example: synthetic testosterone, Growth hormone (GH); growth factor I (IGF-I) taking part in a regular physical training program; using antiretrovirals and/or anticonvulsants and/or immunosuppressant drugs and/or corticosteroids; making use of current daily or last year alcohol intake above 25g/day; having severe deficiencies (cardiac, respiratory, hepatic, renal, and decompensated hypertension above 140 and 90 mmHg); previous diagnosis of diseases such as: heart valve moderate stenosis, chronic obstructive lung disease (COLD) with Forced expiratory volume (FEV-1) lower 50% previously diagnosed, hypothyroidism with altered levels of thyroid stimulating hormone (TSH) or free thyroxine (T4)T4; hypo or hyper cortisolism; chronic kidney disease with glomerular filtration rate estimated below 30ml/min.1.73m2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).equation; infectious-contagious disease; human immunodeficiency vírus (HIV), hepatitis, and diabetes mellitus with lesions in the target organ of any gravity and difficult to control clinically; using two or more hypoglycemic drugs; insulin therapy or with glycated hemoglobin (HbG) higher 8.5%; patients who experienced clinical complications requiring hospitalization or an emergency unit within the 90 days preceding the evaluations of the study protocol or who were bedridden for the same period, and patients with the following conditions: using medications that could alter body composition or physical performance, any clinically decompensated chronic disease, neurological disease, except for osteoporosis, pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To check the history and risk for falls and fractures, using the Timed up and Go (TUG) method of the Physiological Profile Approach (PPA) - Short Form) and HOME FAST BRASIL Self-reported version. We will see if multi-component exercises combined with vitamin D and calcium supplementation will show reduce the risk of falls and fractures compared to the vitamin D and calcium groups.;To assess postural balance using the Physiological Profile Approach (PPA) - Short Form method). We will see if multi-component exercises combined with vitamin D and calcium supplementation will show improvement in postural balance compared to the vitamin D and calcium groups.;To measure the muscle strength through the isometric of the lower limbs with a manual dynamometer (Lafayette); through the sit and stand test 5 times and handgrip dynamometer. We will see if multi-component exercises combined with vitamin D and calcium supplementation will show improvement in strength lower limb muscle and power compared to the vitamin D and calcium groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Screening of Sarcopenia. We will see if multi-component exercises combined with vitamin D and calcium supplementation will show improvement in strength and muscle mass compared to the vitamin D and calcium groups.;To assess fear of falling.We will see if multi-component exercises combined with vitamin D and calcium supplementation will show improvement in reduce the fear of falling and the risk of falls compared to the vitamin D and calcium groups.;The Home Falls and Accidents Screening.We will see if multi-component exercises combined with vitamin D and calcium supplementation will show improvement in reduce falling and the risk of falls compared to the vitamin D and calcium groups.;To assess the bone biomarkers (osteocalcin, carboxyterminal-Ctx and type 1 procollagen) in blood samples by electrochemiluminescence method. We will see if multi-component exercises combined with vitamin D and calcium supplementation will show improvement in reduce falling and the risk of falls compared to the vitamin D and calcium groups. ;To analyze the gait (cadence, step length) by G-Walk device. We will see if multi-component exercises combined with vitamin D and calcium supplementation will show improvement in functional mobility comparison to the vitamin D and calcium group.;To measure the muscular architecture of the vastus lateralis and gastrocnemius through ultrasound. We will see if multi-component exercises combined with vitamin D and calcium supplementation will show improvement in muscle mass compared to the vitamin D and calcium groups.;To check the quality of life Osteoporosis Assessment Questionnaire (OPAQ). We will see if multi-component exercises combined with vitamin D and calcium supplementation will show improvement in quality of life comparad to the vitamin D and calcium group. | — |
Countries
Brazil
Contacts
Public ContactAnna Gomes
Outcome results
None listed