Clinical trial NCT06081764: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis Risk
Keywords: Functional Fitness Age
Osteoporosis
Otago Exercise Program
Post-Menopausal Woman
Quality of Life
Physical Fitness
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 54
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Lower Extremity Strength
timeFrame: 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.
measure: Upper Extremity Strength
timeFrame: 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.
measure: Aerobic Endurance
timeFrame: 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.
measure: Upper Extremity Flexibility
timeFrame: 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.
measure: Agility
timeFrame: 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.
measure: Quality of Life of Individual
timeFrame: 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 outcomes:
measure: Dynamic Balance
timeFrame: 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 outcomes:
measure: Physical Activity Level
timeFrame: 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.
Locations:
city: Gölhisar
country: Turkey
facility: Burdur Mehmet Akif Ersoy University
state: Burdur
Study officials:
affiliation: Pamukkale University
name: Nilüfer Çetişli Korkmaz, Prof.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.