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

Sponsor

Pamukkale University (Other)

Overall Status

Completed

CT.gov ID

NCT06081764

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Risk	Other: Exercise	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jan 15, 2022

Actual Primary Completion Date :

Feb 15, 2023

Actual Study Completion Date :

Feb 15, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Lower Extremity Strength [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.
Upper Extremity Strength [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.
Aerobic Endurance [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 [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.
Agility [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.
Quality of Life of Individual [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 Outcome Measures

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.]
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 Outcome Measures

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.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

54 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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