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

NCT06081764 | Completed

• 1 other identifier: 03.12.2021-E.136626
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis Risk

Keywords

Functional Fitness Age; Osteoporosis; Otago Exercise Program; Post-Menopausal Woman; Quality of Life; Physical Fitness

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• 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 Outcomes (1)

• Physical Activity Level

  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.

Study Arms (2)

Otago Exercise Program

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Exercise OTHER

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.

Otago Exercise Program

Eligibility Criteria

• Age: 54 Years - 75 Years
• Gender Eligibility Details: Only female individuals were included in the clinical trial.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Burdur Mehmet Akif Ersoy University

Gölhisar, Burdur, 15400, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 27613719 BACKGROUND

• 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.

  PMID: 31193284 BACKGROUND

• 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.

  PMID: 29987247 BACKGROUND

• 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.

  PMID: 20817938 BACKGROUND

• 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.

  PMID: 36339194 BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nilüfer Çetişli Korkmaz, Prof.

  Pamukkale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: October 13, 2023
• Study Start: January 15, 2022
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)