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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis Risk
• Intervention / Treatment: Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Burdur
    • Gölhisar, Burdur, Turkey, 15400
      • Burdur Mehmet Akif Ersoy University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Otago Exercise Program; 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; 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.
No Intervention: Control Group; No program were applied to the participants in the control group.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Level	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.	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.

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Study Director: Nilüfer Çetişli Korkmaz, Prof., Pamukkale University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Osteoporosis; Physical Fitness; Otago Exercise Program; Functional Fitness Age; Post-Menopausal Woman
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: 03.12.2021-E.136626

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No