Investigation of the Effects of Physical Activity in Women at Risk of Osteoporosis

Study Overview
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Brief Summary
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The goal of this clinical trial is to investigate the effects of the increase in the physical activity level of women at risk for osteoporosis in the post-menopausal period on the physical fitness, functional fitness age and quality of life. The main question it aims to answer is: • Does the increase in the level of physical activity positively affect the physical fitness parameters (strength, endurance, balance, agility and flexibility), functional fitness ages and quality of life of post-menopausal women with moderate to high osteoporosis risk? Participants in the intervention group were given the Otago Exercise Program, which will last 3 days a week and an average of 30 minutes per day for 12 weeks. The exercises were done one-by-one with a physiotherapist. No program were applied to the participants in the control group, and they were asked to continue their daily living activities in the same way. Researchers will compare two groups to see if there is a difference in effects of Otogo Exercise Program on physical fitness, functional fitness age, and quality of life.

Detailed Description
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The osteoporosis risks of the participants were calculated according to the Osteoporosis Self-Assessment Tool for Women (OST). Women have medium and high risk were included in the study. Otago Exercise Program includes strengthening exercises consisting of knee extension, knee flexion, hip abduction, ankle dorsi flexion, and 12 balance exercises consisting of plantar flexion and squatting, walking backward, walking and rolling back, sideways walking, tandem stance, tandem gait, standing on one leg, heels walking on toes, walking on tiptoe, sitting and standing, climbing and descending stairs, and backward tandem walking. • In addition, moderate-intensity walking exercise for 30 minutes a day, 2 days a week, was recommended to the patients in experimental group.

Official Title
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Investigation of the Effects of Physical Activity on Physical Fitness Parameters, Functional Fitness Age and Quality of Life in Women at Risk of Osteoporosis

Conditions
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Osteoporosis Risk

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being at medium-high risk as a result of the Osteoporosis Self-Assessment Tool for Women (OST) Being 54 years old and over Being in the post-menopausal period Exclusion Criteria: Having a broken history Having a history of surgery in the last 1 year Having a cognitive or physical condition that will prevent them from exercising Exercising regularly for more than 30 minutes a day, at least 3 days a week

Ages Eligible for Study
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Minimum Age: 54 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Otago Exercise Program<br>They participated the Otago Exercise Program, which last 3 days a week and an average of 30 minutes per day for 12 weeks in total. In addition, they did moderate-intensity walking exercise for 30 minutes a day, 2 days a week. | Other: Exercise<br>* Doing Otago Exercise Program, which lasting 3 days a week and an average of 30 minutes per day under the supervision of a physiotherapist. Also doing walking exercise for 30 minutes a day, 2 days a week for total of 12 weeks.<br>|
| No Intervention: Control Group<br>No program were applied to the participants in the control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Extremity Strength | Lower extremity strength will be evaluated with the 30-second sit-stand test included in the ''Senior Fitness Test'', which is a physical fitness assessment tool. | The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment. | 
| Upper Extremity Strength | Upper extremity strength will be evaluated with the 30-second elbow bend test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool. | The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment. | 
| Aerobic Endurance | Aerobic endurance will be evaluated with the 2-minute walking test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool. | The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment. | 
| Upper Extremity Flexibility | Upper extremity flexibility will be evaluated with the sit-reach test and back scratching test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool. | The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment. | 
| Agility | Agility will be evaluated with the stand-up and walk test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool. | The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment. | 
| Quality of Life of Individual | Quality of Life was tested with the ''Quality of Life for Osteoporosis Questionnaire''. The scale consists of 41 questions. There are 5 subscales: pain (5 items), physical function (17 items), social activity (7 items), general health assessment (3 items) and mental function (9 items). For each subgroup and total result in the scale, 0 points indicate the best health status, while higher scores indicate poor quality of life. | The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Balance | In addition to evaluating agility with the standing and walking test included in the Senior Fitness Test, which is a physical condition evaluation tool, dynamic balance will also be evaluated since this test is an indicator of dynamic balance. | The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Fitness Age, Osteoporosis, Otago Exercise Program, Post-Menopausal Woman, Quality of Life, Physical Fitness