NCT06846697

Brief Summary

The vertebral column is an S-shaped structure that carries the body weight and transmits it to the feet. Kyphosis, a natural curvature of the spine, can increase with poor posture and muscle weakness, leading to postural kyphosis. This condition results in forward head positioning, rounded shoulders, and scapular winging, causing back pain, poor posture, balance issues, and respiratory difficulties. With technological advances, poor posture habits have become more common, especially in adolescents. Kyphosis can also affect balance, walking speed, and increase the risk of falls in older adults. Exercises like Hatha yoga and reformer Pilates are effective methods for improving posture, muscle strength, and quality of life. The aim of this study is to compare the effects of Hatha yoga and reformer Pilates exercises on posture, pain, balance, quality of life, body image, and respiratory function in individuals with hyperkyphosis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Apr 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Apr 2025Jun 2026

First Submitted

Initial submission to the registry

February 5, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Expected
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

February 5, 2025

Last Update Submit

September 8, 2025

Conditions

Keywords

Hatha YogaReformer Pilates

Outcome Measures

Primary Outcomes (20)

  • New York Posture Evaluation Scale

    The New York Posture Evaluation Scale was first published in 1958. It evaluates the body in 13 different parts in terms of posture changes that may occur. If the posture is correct, 5 points are given, 3 points if it is moderately impaired, and 1 point if it is severely impaired. The total score obtained as a result of the test varies between 13-65 points. A high score means that the posture is good.

    At baseline and after 8 weeks

  • Measurement of the degree of kyphosis with Flexicurve

    Flexicurve will be used to determine the degree of hyperkyphosis. Flexicurve, a noninvasive method, is recommended as a practical and affordable tool for monitoring age-related spinal degenerative processes and curvature changes. One end of the Flexicurve is placed on the bony prominence of the cervical seventh (C7) vertebra and caudally along the spine to the thoracic twelfth vertebra. The mould is then removed from the spine and the shape transferred to paper. Showing the relationship between the length and width of the thorax; Values are obtained according to the formula (width / length) x 100

    At baseline and after 8 weeks

  • Determination of the distance between the occiput and the wall

    It is a practical method widely used for screening and monitoring hyperkyphosis. The individual's back and heels should be as close to the wall as possible and the head should remain in a natural position. Hyperkyphosis is considered to be present if the occiput does not touch the wall when the back and heels are against the wall and the head is facing forwards. The degree of hyperkyphosis is assessed by measuring the distance between the occiput and the wall. The severity of hyperkyphosis is classified as mild (≤5 cm), moderate (5.1-8 cm) and severe (\>8 cm).

    At baseline and after 8 weeks

  • Determination of the distance between wall C7

    There are also studies suggesting that it would be more appropriate to use C7 in the measurement because it is closer and adjacent to the thoracic vertebrae than the occiput. Due to the close location of C7 to the thoracic vertebrae, errors that may be encountered when the participant moves his/her head will be prevented. The measurement is performed with the back, heels and sacrum against the wall, in as upright a posture as possible and looking forwards. The distance of the spinous process of C7 perpendicular to the wall is measured using two rulers. According to the test results, the severity of hyperkyphosis is expressed in three different levels: mild (≤ 5 cm), moderate (5.1- 8 cm) and severe (\> 8 cm).

    At baseline and after 8 weeks

  • Visual Analogue Scale

    Perceived pain ranges from no pain to extreme pain. For pain intensity according to the VAS, 'no pain' is graded as 0 points and 'worst possible pain' is graded as 10 points.

    At baseline and after 8 weeks

  • Timed balance test

    In this test, the duration of standing on one and two legs with eyes open and closed is analysed. It is a static balance test

    At baseline and after 8 weeks

  • Flamingo balance test

    It is a test that measures the duration of static balance in seconds within a one-minute evaluation process. The tool used as an auxiliary material is fixed on the floor. The person conducting the research sits facing the person with the stopwatch. The second observer stands next to the person to help ensure the balance of the person and to see the number of errors in the instrument. One foot of the person stays in the air during this test and when this foot touches the ground or when the person drops this foot completely, the error is recorded and the stopwatch is stopped. After the balance is restored, the stopwatch is restarted and the best score is taken and recorded as the test score. If the person makes fifteen or more errors within 30 seconds after the balance is restored, the test score is reflected as 0.

    At baseline and after 8 weeks

  • Timed up and go test

    This test requires a chair, a stopwatch and a three-metre walking space. The test starts with sitting on a chair, the individual gets up with a warning, walks 3 metres, returns and sits down. It is a test used in dynamic balance assessment.

    At baseline and after 8 weeks

  • Functional reach test

    With the help of a tape measure mounted on the wall, the ability of the subjects to reach without losing their balance is evaluated. It is a test used in dynamic balance assessment.

    At baseline and after 8 weeks

  • Nottingham Health Profile (NHP)

    It is used to assess quality of life. The questionnaire consists of 38 items. It evaluates six dimensions of quality of life including energy; 3 items, pain; 8 items, emotional reactions; 9 items, sleep; 5 items, social isolation; 5 items, physical activity; 8 items. Each section is scored between 0-100, '0' indicates the best health status, while 100 points indicates the worst health status.

    At baseline and after 8 weeks

  • Body Image Assessment

    It will be evaluated with the Multidimensional Body-Image Self-Relationship Scale (MBSRI). This scale is a scale that evaluates the body image of the individual in terms of self-attitudinal aspects. The scale also includes sub-headings that include evaluations of the individual's satisfaction with body image, physical capacity and health status. The scale consists of seven subheadings and 57 items in total. The subheadings generally provide psychological and physical evaluations. In the scale, emotional-cognitive-behavioural evaluations are made on the psychological side and physical appearance-physical competence and biological integrity evaluations are made on the physical side. A maximum score of 285 and a minimum score of 57 can be obtained from the scale.

    At baseline and after 8 weeks

  • Pulmonary Function Test (SFT)

    In our study, SFT measurements will be performed with COSMED Pony FX device (Italy, 2011). Within the scope of the measurement rules, it will be ensured that the subjects have not eaten for at least 2 hours, have not drunk alcohol for at least 4 hours and have not smoked for at least 24 hours. In the test performed in the sitting position, the subjects will be asked to breathe normally for 4 or 5 times, then to make a deep inspiration, followed by a forced, rapid and deep expiration to release all the air. At least three repeated measurements will be performed and the measurement with the highest value in the sum of FEV1 and FVC recommended by ATS will be recorded.

    At baseline and after 8 weeks

  • Chest circumference measurement

    It is performed to evaluate thoracic expansion, chest wall mobility and respiratory type. A bendable, non-elastic tape measure not wider than 7 mm is preferred and measurements are made with feet shoulder-width apart and body weight equally distributed on both feet. In addition, the arms should be slightly abducted for comfortable measurement. In our study, measurements will be performed from three different regions: axillary (4th costal level), epigastric (xiphoid process level) and subcostal (9th costal level) during maximal inspiration, maximal expiration and normal respiratory phase using a tape measure in standing position. The measurements will be repeated three times and the highest value will be recorded. Then, the difference between maximal inspiration and expiration will be found and recorded separately for each region.

    At baseline and after 8 weeks

  • Total body weight measurement

    Total body weight measurement will be performed with a Tanita BC-700 (Tanita-Japan) body analyzer as weight in kilograms.

    At baseline and after 8 weeks

  • Height measurement

    Height in meters will be measured with a height measuring tape.

    At baseline and after 8 weeks

  • Body mass index calculation

    Weight and height will be combined to report BMI in kg/m\^2).

    At baseline and after 8 weeks

  • Lower extremity fat percentage measurement

    Lower extremity fat percentage will be measured using a Tanita BC-700 (Tanita-Japan) body analyzer.

    At baseline and after 8 weeks

  • Total body fat percentage measurement

    Total body fat percentage measurement will be measured using a Tanita BC-700 (Tanita-Japan) body analyzer.

    At baseline and after 8 weeks

  • Lower extremity muscle percentage measurement

    Lower extremity muscle percentage measurement will be measured using a Tanita BC-700 (Tanita-Japan) body analyzer.

    At baseline and after 8 weeks

  • Total body muscle percentage measurement

    Total body muscle percentage measurement will be measured using a Tanita BC-700 (Tanita-Japan) body analyzer.

    At baseline and after 8 weeks

Study Arms (3)

Control group

OTHER

This group will be given a home programme. They will be asked to do the exercises regularly and fulfil the recommendations given and will be asked to come to the control at the end of 8 weeks. During this period, individuals will be followed up weekly by telephone.

Other: Home-based Exercise

Hatha Yoga Group

EXPERIMENTAL

Participants in this group, who will also be given a home programme, will participate in Hatha yoga exercises 3 times a week for a total of 8 weeks with a session duration of 45 minutes, accompanied by a physiotherapist with a yoga instructor certificate. In this group, Hatha yoga exercises will be applied by focusing on postural control and respiration during exercise.

Other: Home-based ExerciseOther: Hatha Yoga Group

Reformer Pilates Group

EXPERIMENTAL

In this group, which will be given a home programme, participants will perform the exercises 3 times a week for a total of 8 weeks with a session duration of 45 minutes, accompanied by a physiotherapist with a pilates instructor certificate.In this group, which will be given a home programme, participants will perform the exercises 3 times a week for a total of 8 weeks with a session duration of 45 minutes, accompanied by a physiotherapist with a pilates instructor certificate. In this group, reformer pilates exercises will be applied by focusing on postural control during exercise.

Other: Home-based ExerciseOther: Reformer Pilates Group

Interventions

The subjects in this group will be given the exercises included in the Physical Activity guideline of the Ministry of Health as a home programme.

Also known as: HBE
Control groupHatha Yoga GroupReformer Pilates Group

The sessions will begin with the classic sun salutation series (Suryanamaskar) consisting of 12 basic poses of yoga. The sun salutation series will be used as a warm-up for 10 minutes. After warming up, postures aimed at stretching the front group muscles of the body and strengthening the back group muscles will be preferred. In the cooling phase, the session will be ended by relaxing with Savasana pose for 10 minutes.

Also known as: HYG
Hatha Yoga Group

Exercise sessions will start with the foot series and the starting position on the back will be preferred. This series, which is progressed by maintaining the body composition, is considered as a warm-up exercise of the body. Then, the body is continued with exercise series targeting the thoracic region and core region.

Also known as: RPG
Reformer Pilates Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postural hyperkyphosis
  • Not receiving physiotherapy in the last 6 months

You may not qualify if:

  • Exercise is not indicated
  • Communication problems
  • Having a concomitant orthopaedic disorder
  • The presence of a concomitant neurological disorder
  • Presence of concomitant cardiopulmonary disease
  • Presence of recurrent infection
  • Presence of open wound and/or incision
  • Presence of other spinal conditions such as scoliosis
  • Being diagnosed with kyphosis other than postural kyphosis in the classification system
  • Previously undergone a related surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Betül TAŞPINAR

Konak, İ̇zmi̇r, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Onur Engin, Assist.Prof.

    Izmir Democracy University

    PRINCIPAL INVESTIGATOR
  • Ferruh Taspinar, Prof.Dr.

    Izmir Democracy University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Betül Taspinar, Prof. Dr.

CONTACT

Ayşe Akkuş, Msc. Pt.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 26, 2025

Study Start

April 30, 2025

Primary Completion

February 15, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

September 9, 2025

Record last verified: 2025-09

Locations