- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07245355
Contribution of Recreational Exercises to Balance and Muscle Strength in Osteoporosis Risk
Effects of Recreational Exercises (Swimming, Pilates, and Walking) on Muscle Strength and Balance in Women at Risk for Osteoporosis
This study aims to evaluate the effects of recreational exercises such as Pilates, swimming and walking on muscle strength and balance in women at risk of osteoporosis.
Study hypotheses:
H1: Pilates exercises will be more effective than walking exercises in improving muscle strength among women at risk of osteoporosis.
H2: Swimming exercises will be more effective than walking exercises in improving muscle strength among women at risk of osteoporosis.
H3: Pilates exercises will be more effective than walking exercises in improving balance among women at risk of osteoporosis.
H4: Swimming exercises will be more effective than walking exercises in improving balance among women at risk of osteoporosis.
H5: Pilates and swimming exercises will have similar effects on improving muscle strength and balance among women at risk of osteoporosis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants were selected from among women who had previously been diagnosed with osteoporosis risk by a physician and who applied to the Isparta Merwellness Pilates gym for exercise.
The study is planned as a randomized controlled prospective trial. Participants were assigned to three groups using a computer-generated random number table (n=20).
Pilates Group: Mat Pilates was performed three days a week for 45 minutes. Swimming Group: Moderate-intensity swimming was performed 3 days a week for 40 minutes.
Walking Group: Brisk walking was performed 3 days a week for 45 minutes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: NUR ALP, MSc
- Phone Number: +905339738832
- Email: nuralp@sdu.edu.tr
Study Contact Backup
- Name: REHA BOZGÜNEY, MSc
- Phone Number: +05536053999
- Email: rehabozguney@sdu.edu.tr
Study Locations
-
-
-
Isparta, Turkey (Türkiye)
- Recruiting
- Suleyman Demirel University
-
Contact:
- REHA BOZGÜNEY, MSc
- Phone Number: +05536053999
- Email: rehabozguney@sdu.edu.tr
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Contact:
- Nur ALP, MSc,Lecturer
- Phone Number: +905339738832
- Email: nuralp@sdu.edu.tr
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Principal Investigator:
- HULUSİ ALP, Professor
-
Sub-Investigator:
- ZEYNEP SENEM SÖYLEYİCİ, ASSOCIATE PROFESSOR
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Sub-Investigator:
- REHA BOZGÜNEY, MSc
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Sub-Investigator:
- NUR ALP, MSc
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Sub-Investigator:
- İBRAHİM KUBİLAY TÜRKAY, ASSOCIATE PROFESSOR
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having a sedentary lifestyle (not having exercised regularly in the past 6 months),
- No musculoskeletal or neurological conditions that would prevent participation,
- Voluntarily agreeing to participate in the study.
Exclusion Criteria:
- Use of medications affecting bone metabolism (e.g., bisphosphonates, corticosteroids),
- History of fracture within the past 6 months,
- Uncontrolled cardiovascular or metabolic diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates Group
Pilates Group: Mat Pilates was performed three days a week for 45 minutes.
The programme included a 10-minute warm-up, 30 minutes of basic Pilates exercises (hundred, roll-up, spine stretch, single leg stretch) and a 5-minute cool-down and stretching phase.
The exercises were conducted by a certified Pilates instructor.
|
Sixty women aged 40-60 years with a T-score between -1.0 and -2.5 were randomly assigned to three groups (Pilates, Swimming, Walking; n=20). Participants exercised for 40-45 minutes three days a week for 12 weeks.All exercises in this group were conducted by a certified Pilates instructor. Pilates exercises were performed on a mat.Session Content: Warm-Up (10 min): Breathing exercises, shoulder rotation, neck stretch, posterior pelvic tilt, and spinal mobilization exercises were performed. Main Section (30 min): Weeks 1-4: Basic movements - Hundred, Roll-Up, Single Leg Stretch, Spine Stretch Weeks 5-8: Intermediate variations - Double Leg Stretch, Rolling Like a Ball, Saw Weeks 9-12: Advanced balance-focused movements - Teaser Prep, Side Kick Series, Swimming, Leg Pull Front Cool-Down (5 min): Deep breathing exercises, hamstring stretching, and spinal Participation rates were regularly recorded, and individuals who participated below 80% of the program were excluded from the analysis. |
|
Experimental: Swimming Group
Swimming Group: Moderate-intensity swimming was performed 3 days a week for 40 minutes.
The exercises included a 5-minute warm-up, 30 minutes of freestyle and backstroke swimming, and a 5-minute cool-down phase.
Participants' heart rates were maintained at 60- 70% of their maximum heart rate.
|
Participants in the swimming group completed moderate-intensity swimming exercises for 40 minutes, three days a week. The program consisted of a 5-minute warm-up, 30 minutes of freestyle and backstroke swimming, and a 5-minute cool-down. Participants' heart rates were maintained between 60 and 70% of their maximum heart rate. Session content: Warm-up (5 min): Light swimming, in-water mobilization exercises Main Part (30 min): Weeks 1-4: Freestyle swimming with 25-50 m rest intervals Weeks 5-8: Alternating freestyle and backstroke swimming with 75-100 m rest intervals. Weeks 9-12: Continuous swimming sets (150-200 m) - technical development and endurance Cool down (5 min): Light swimming, stretching in the water Exercise intensity was monitored using the Borg Scale of Perceived Exertion (RPE). Participation rates were regularly recorded, and individuals who participated below 80% of the program were excluded from the analysis. |
|
Experimental: Walking Group
Brisk walking was performed 3 days a week for 45 minutes.
The programme consisted of a 5-minute warm-up walk, 35 minutes of walking at 60-70% of maximum heart rate, and a 5-minute cool-down walk.
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Individuals in this group participated in brisk walking at 60-70% of their maximum heart rate for 45 minutes, three days a week. The program consisted of a 5-minute warm-up walk, a 35-minute brisk walk, and a 5-minute cool-down walk. A 45-minute walking program was designed three days a week (Tuesday, Thursday, Saturday). Terrace: Flat, safe walking track Intensity: 60-70% of maximum heart rate Session Contents: Warm-Up (5 min): Light walking, shoulder and hip mobilization Main Part (35 min): Weeks 1-4: 5-6 km/h brisk walking Weeks 5-8: 6-6.5 km/h brisk walking Weeks 9-12: 6.5-7 km/h brisk walking Cool-Down (5 min): Slow walking, calf, hamstring, and lower back stretching exercises.Exercise intensity was monitored in all groups using the Borg Scale of Perceived Exertion (RPE). Participation rates were regularly recorded, and individuals who participated below 80% of the program were excluded from the analysis. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Handgrip strength
Time Frame: At baseline and at the end of the 12-week intervention
|
Handgrip strength was measured using a digital hand dynamometer (Jamar Plus+, kg).
Three repetitions were taken during the measurements, and the highest value was recorded.
The Jamar dynamometer has high reliability in individuals with osteoporosis (ICC = 0.95).
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At baseline and at the end of the 12-week intervention
|
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Trunk flexor and extensor strength
Time Frame: At baseline and at the end of the 12-week intervention
|
Trunk flexor and extensor strength were assessed using isokinetic dynamometry (Biodex System 4) at a speed of 60°/s.
This method has been reported as a valid measurement tool for elderly individuals and those at risk of osteoporosis.
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At baseline and at the end of the 12-week intervention
|
|
Berg Balance Scale (BBS)
Time Frame: At baseline and at the end of the 12-week intervention
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Berg Balance Scale (BBS): A 14-item test scored between 0 and 56.
The reliability coefficient in the Turkish adaptation was found to be 0.98.
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At baseline and at the end of the 12-week intervention
|
|
Computerised posturography:
Time Frame: At baseline and at the end of the 12-week intervention
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Computerised posturography: Static and dynamic balance were assessed, and centre of pressure (CoP) oscillation (mm) was recorded.
Posturography is a widely used objective method in the osteoporotic population.
|
At baseline and at the end of the 12-week intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: HULUSİ ALP, Professor, Suleyman Demirel University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SuleymanDU-97/14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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