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

Primary Purpose

Osteoporosis Risk

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis Risk focused on measuring Functional Fitness Age, Osteoporosis, Otago Exercise Program, Post-Menopausal Woman, Quality of Life, Physical Fitness

Eligibility Criteria

54 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Burdur Mehmet Akif Ersoy University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Otago Exercise Program

Control Group

Arm Description

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.

No program were applied to the participants in the control group.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 25, 2023
Last Updated
October 10, 2023
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT06081764
Brief Title
Investigation of the Effects of Physical Activity in Women at Risk of Osteoporosis
Official Title
Investigation of the Effects of Physical Activity on Physical Fitness Parameters, Functional Fitness Age and Quality of Life in Women at Risk of Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
February 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis Risk
Keywords
Functional Fitness Age, Osteoporosis, Otago Exercise Program, Post-Menopausal Woman, Quality of Life, Physical Fitness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Otago Exercise Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No program were applied to the participants in the control group.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lower Extremity Strength
Description
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.
Time Frame
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.
Title
Upper Extremity Strength
Description
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.
Time Frame
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.
Title
Aerobic Endurance
Description
Aerobic endurance will be evaluated with the 2-minute walking test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool.
Time Frame
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.
Title
Upper Extremity Flexibility
Description
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.
Time Frame
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.
Title
Agility
Description
Agility will be evaluated with the stand-up and walk test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool.
Time Frame
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.
Title
Quality of Life of Individual
Description
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.
Time Frame
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 Measure Information:
Title
Dynamic Balance
Description
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.
Time Frame
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.
Other Pre-specified Outcome Measures:
Title
Physical Activity Level
Description
The physical activity levels of the participants were evaluated with the Global Physical Activity Questionnaire. This survey, consisting of a total of 16 questions, evaluates physical activity participation in 3 different areas. These areas; work-related, transfers (walking, cycling) and leisure activities. Calculation of the total score includes the sum of the duration (minutes) and frequency (days) of walking, moderate activity and vigorous activity. The energy required for activities is calculated with the MET-minute score. An increase in this score indicates that the daily and weekly physical activity level increases.
Time Frame
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.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female individuals were included in the clinical trial.
Minimum Age & Unit of Time
54 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilüfer Çetişli Korkmaz, Prof.
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Burdur Mehmet Akif Ersoy University
City
Gölhisar
State/Province
Burdur
ZIP/Postal Code
15400
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27613719
Citation
Wen HJ, Huang TH, Li TL, Chong PN, Ang BS. Effects of short-term step aerobics exercise on bone metabolism and functional fitness in postmenopausal women with low bone mass. Osteoporos Int. 2017 Feb;28(2):539-547. doi: 10.1007/s00198-016-3759-4. Epub 2016 Sep 9.
Results Reference
background
PubMed Identifier
31193284
Citation
Latorre-Rojas EJ, Prat-Subirana JA, Peirau-Teres X, Mas-Alos S, Beltran-Garrido JV, Planas-Anzano A. Determination of functional fitness age in women aged 50 and older. J Sport Health Sci. 2019 May;8(3):267-272. doi: 10.1016/j.jshs.2017.01.010. Epub 2017 Jan 23.
Results Reference
background
PubMed Identifier
29987247
Citation
Subramaniam S, Ima-Nirwana S, Chin KY. Performance of Osteoporosis Self-Assessment Tool (OST) in Predicting Osteoporosis-A Review. Int J Environ Res Public Health. 2018 Jul 9;15(7):1445. doi: 10.3390/ijerph15071445.
Results Reference
background
PubMed Identifier
20817938
Citation
Thomas S, Mackintosh S, Halbert J. Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing. 2010 Nov;39(6):681-7. doi: 10.1093/ageing/afq102. Epub 2010 Sep 4.
Results Reference
background
PubMed Identifier
36339194
Citation
Yang Y, Wang K, Liu H, Qu J, Wang Y, Chen P, Zhang T, Luo J. The impact of Otago exercise programme on the prevention of falls in older adult: A systematic review. Front Public Health. 2022 Oct 20;10:953593. doi: 10.3389/fpubh.2022.953593. eCollection 2022.
Results Reference
background

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

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