Skip to main content
OpenTrials
Completed

NCT Number: NCT06081764

Investigation of the Effects of Physical Activity 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Risk Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

54 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Burdur Mehmet Akif Ersoy University

Gölhisar, Burdur, 15400, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Lower Extremity Strength

    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.

    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.

  2. Upper Extremity Strength

    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.

    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.

  3. Aerobic Endurance

    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.

    Aerobic endurance will be evaluated with the 2-minute walking test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool.

  4. Upper Extremity Flexibility

    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.

    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.

  5. Agility

    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.

    Agility will be evaluated with the stand-up and walk test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool.

  6. Quality of Life of Individual

    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.

    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 outcomes

  1. 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.

    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.

Other outcomes

  1. Physical Activity Level

    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.

    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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2023
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.