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Clinical Trials/NCT06081764
NCT06081764
Completed
N/A

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

Pamukkale University1 site in 1 country40 target enrollmentJanuary 15, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoporosis Risk
Sponsor
Pamukkale University
Enrollment
40
Locations
1
Primary Endpoint
Lower Extremity Strength
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2022
End Date
February 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fatma Nur Alçın

Principal Investigator

Pamukkale University

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

Secondary Outcomes

  • 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.)

Study Sites (1)

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