NCT07068113

Brief Summary

The aim of this study is to evaluate the effects of regular Turkish regional dances, in addition to conventional exercises given with a home program, on the quality of life, balance, aerobic capacity, bone mineral density (femoral neck, total and lumbar L1-4 and L2-4 T scores) and bone turnover markers (Type 1 collagen C-telopeptide \[CTX-1\] and Serum Procollagen 1 N-terminal peptide \[P1NP\]) of postmenopausal osteopenic women aged 50-60 years. Our study also aims to evaluate the compliance of patients to the exercise programs given to postmenopausal osteopenic women.

  • What is the effect of regular Turkish regional dances on balance, aerobic capacity, muscle strength, quality of life, Bone Mineral Densitometry and Bone Turnover Markers in postmenopausal osteopenic women?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

March 12, 2026

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

July 4, 2025

Last Update Submit

March 11, 2026

Conditions

Keywords

osteopeniapostmenopausal womenTurkish Dancebone turnover markersBone Mineral Density

Outcome Measures

Primary Outcomes (6)

  • Bone Turnover Markers(Type 1 collagen C-telopeptide)

    Serum Type 1 collagen C-telopeptide (CTX-1) will be used for bone resorption.

    three month

  • Bone Turnover Markers(Serum Procollagen 1 N-terminal peptide)

    Serum Procollagen 1 N-terminal peptide (P1NP) will be used for bone formation

    three month

  • Bone Mineral Density(Femoral Neck T scores)

    In our study, femoral neck T scores bone mineral densities in g/cm2 will be noted with Dual-energy X-ray absorptiometry .Values obtained by bone mineral density (BMD) measurement are divided into diagnostic classification by the World Health Organization (WHO) as normal bone mass, low bone mass (osteopenia) and osteoporosis. Normal bone mass is above -1 standard deviation point relative to the mean bone mineral density of the young adult reference population (T score -1 and above). Osteopenia (low bone mass) is when the bone mineral density is below -1 standard deviation score and above -2.5 standard deviation points compared to the average bone mineral density of the young adult reference population (T score between -1 and -2.5). Osteoporosis is defined as bone mineral density below -2.5 standard deviation points compared to the average of the young adult reference population (T score below -2.5 points).

    six month

  • Bone Mineral Density(Femoral total T scores)

    In our study, femoral total T scores and bone mineral densities in g/cm2 will be noted with Dual-energy X-ray absorptiometry.Values obtained by bone mineral density (BMD) measurement are divided into diagnostic classification by the World Health Organization (WHO) as normal bone mass, low bone mass (osteopenia) and osteoporosis. Normal bone mass is above -1 standard deviation point relative to the mean bone mineral density of the young adult reference population (T score -1 and above). Osteopenia (low bone mass) is when the bone mineral density is below -1 standard deviation score and above -2.5 standard deviation points compared to the average bone mineral density of the young adult reference population (T score between -1 and -2.5). Osteoporosis is defined as bone mineral density below -2.5 standard deviation points compared to the average of the young adult reference population (T score below -2.5 points).

    six month

  • bone mineral density(lumbar 1-4 Tscores)

    In our study, lumbar 1-4 T scores bone mineral densities in g/cm2 will be noted with Dual-energy X-ray absorptiometry .Values obtained by bone mineral density (BMD) measurement are divided into diagnostic classification by the World Health Organization (WHO) as normal bone mass, low bone mass (osteopenia) and osteoporosis. Normal bone mass is above -1 standard deviation point relative to the mean bone mineral density of the young adult reference population (T score -1 and above). Osteopenia (low bone mass) is when the bone mineral density is below -1 standard deviation score and above -2.5 standard deviation points compared to the average bone mineral density of the young adult reference population (T score between -1 and -2.5). Osteoporosis is defined as bone mineral density below -2.5 standard deviation points compared to the average of the young adult reference population (T score below -2.5 points).

    six month

  • bone mineral density(lumbar 2-4 T scores)

    In our study, lumbar 2-4 T scores bone mineral densities in g/cm2 will be noted with Dual-energy X-ray absorptiometry .Values obtained by bone mineral density (BMD) measurement are divided into diagnostic classification by the World Health Organization (WHO) as normal bone mass, low bone mass (osteopenia) and osteoporosis. Normal bone mass is above -1 standard deviation point relative to the mean bone mineral density of the young adult reference population (T score -1 and above). Osteopenia (low bone mass) is when the bone mineral density is below -1 standard deviation score and above -2.5 standard deviation points compared to the average bone mineral density of the young adult reference population (T score between -1 and -2.5). Osteoporosis is defined as bone mineral density below -2.5 standard deviation points compared to the average of the young adult reference population (T score below -2.5 points).

    six month

Secondary Outcomes (4)

  • BALANCE

    three month

  • muscle strength

    three month

  • aerobic capacity

    three month

  • quality of life measurement

    three month

Study Arms (2)

EXERCISE GROUP

ACTIVE COMPARATOR

Patients are asked to do a home exercise program 3-5 days a week In addition to the exercises, they are asked to walk only 3 days a week, a total of at least 150 minutes per week

Other: EXERCISE GROUP

DANCE GROUP

ACTIVE COMPARATOR

A home exercise program will be done 3-5 days a week In addition to home exercises, patients will be asked to dance with a tempo determined by the study team before the study, lasting 30 minutes, accompanied by dance videos from various regions Before the dance, 10 minutes of WARM-UP EXERCISES will be asked, followed by 30 minutes of dance and 10 minutes of COOL-DOWN EXERCISES. Thus, it is aimed for you to dance at least 50 minutes at least 2 days a week. In addition, it is asked to walk at least 50 minutes at a pace once a week

Other: DANCE GROUP

Interventions

home exercise program + 50 min/week brisk walking + 100 min/week dance

DANCE GROUP

home exercise program + 150 min/week brisk walking

EXERCISE GROUP

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being a postmenopausal woman between the ages of 50-60
  • Not having a known diagnosis of osteoporosis and not having taken any antiresorptive or anabolic agents before
  • Being diagnosed with osteopenia with DEXA taken in the last 6 months at Etlik City Hospital (femoral neck, femoral total L1-4 or L2-4 T score between -1 and -2.5)
  • Being literate
  • Having a 25-Hydroxy vitamin D level in the blood \>20 µg/L
  • Having a phone that can be used for communication for oneself or one of the family members, as well as having a smart phone, tablet or computer that can be used to watch videos
  • Being willing to participate in the study

You may not qualify if:

  • Having a body mass index \>30 kg/m2
  • Having an extremely sedentary lifestyle (International Physical Activity Scale-Inactive according to Short Form)
  • Presence of fragility fracture
  • Presence of malignancy
  • Presence of cardiovascular or respiratory system disease that will prevent exercise (unstable angina, uncontrolled atrial or ventricular arrhythmia, 3rd degree atrioventricular block, severe aortic stenosis, severe asthma-COPD)
  • Presence of current neurological disease that will prevent exercise (CVA, MS)
  • Presence of psychiatric disease that will prevent exercise or cause non-compliance in follow-ups
  • Presence of musculoskeletal system disease that will prevent exercise (Stage 3-4 osteoarthritis, severe spinal stenosis, severe radiculopathy, lumbar surgery within the last 1 year)
  • Presence of known inflammatory joint disease
  • Presence of advanced vision, hearing loss or vertigo etc. that will prevent the patient from doing exercises or regional dances. Having any disease that will disrupt harmony by causing balance problems
  • Using active estrogen or progesterone containing preparations
  • Presence of hyperthyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik Ciy Hospital

Ankara, Yenimahalle, 060000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RESEARCH ASSISTANT

Study Record Dates

First Submitted

July 4, 2025

First Posted

July 16, 2025

Study Start

February 19, 2025

Primary Completion

February 15, 2026

Study Completion

February 15, 2026

Last Updated

March 12, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations