NCT07245355

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
May 2026May 2026

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Expected
Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

Same day

First QC Date

November 17, 2025

Last Update Submit

April 30, 2026

Conditions

Keywords

osteoporosisRecreational Exercise

Outcome Measures

Primary Outcomes (4)

  • Handgrip strength

    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).

    At baseline and at the end of the 12-week intervention

  • Trunk flexor and extensor strength

    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.

    At baseline and at the end of the 12-week intervention

  • Berg Balance Scale (BBS)

    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.

    At baseline and at the end of the 12-week intervention

  • Computerised posturography:

    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

Study Arms (3)

Pilates Group

EXPERIMENTAL

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.

Other: Experimental Group 1

Swimming Group

EXPERIMENTAL

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.

Other: Experimental Group 2

Walking Group

EXPERIMENTAL

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.

Other: Experimental Group 3

Interventions

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.

Pilates Group

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.

Swimming Group

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.

Walking Group

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Use of medications affecting bone metabolism (e.g., bisphosphonates, corticosteroids),
  • History of fracture within the past 6 months,
  • Uncontrolled cardiovascular or metabolic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Süleyman Demirel University

Isparta, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • HULUSİ ALP, Professor

    Suleyman Demirel University

    STUDY DIRECTOR

Central Study Contacts

REHA BOZGÜNEY, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
A single-blind study was designed in which the patients would be unaware of their group allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, MSc.

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

May 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 15, 2026

Last Updated

May 7, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

The data for objectives of the research will be compared after they are received.

Locations