NCT06755957

Brief Summary

Kyphosis-oriented exercise programs consist of isolated stretching, strengthening, and breathing exercises. However, the literature emphasizes that the body is a kinetic chain in many musculoskeletal disorders and supports holistic exercise approaches. To our knowledge, the effects of a complex exercise such as the Wall Angels exercise have not been studied in the kyphotic population. The aim of our study is to investigate whether the Wall Angels exercise combined with standard kyphosis exercises performed at home has additional effects and to contribute to the optimization of kyphosis rehabilitation programs.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Start

First participant enrolled

October 1, 2024

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

2 days

First QC Date

December 13, 2024

Last Update Submit

December 31, 2024

Conditions

Keywords

Corrective ExerciseKyphosisPostureThoracic Mobility

Outcome Measures

Primary Outcomes (9)

  • Postural Habits and Awareness Scale

    Postural habits and awareness levels will be assessed with the Postural Habits and Awareness Scale (PHAS). PHAS is a valid and reliable tool developed to assess postural habits and awareness in healthy adults. This scale consists of four sub-dimensions: postural habits and awareness, awareness of factors that impair posture, ergonomic awareness and positional awareness. PHAS is structured as a 5-point Likert scale consisting of 19 items, 7 of which are related to postural habits and 12 to postural awareness. Participants rate each item on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score on the scale ranges from 0 to 95, with higher scores indicating better postural habits and awareness.

    From enrollment to the end of treatment at 6 weeks

  • Visual Analog Scale (VAS)

    The level of pain will be assessed by the participant using the Visual Analog Scale (VAS) (0: no pain; 100: unbearable pain).

    From enrollment to the end of treatment at 6 weeks

  • Trunk Hyperextension and Lateral Flexion Flexibility Measurement

    Trunk flexibility will be measured using trunk hyperextension and lateral flexion (for right and left sides) tests and a tape measure. For the trunk hyperextension measurement, the participant is asked to stand facing the wall and with their pelvis touching the wall. First, the distance between the sternum notch and the wall is measured and recorded in this position. Then, the participant's pelvis is supported and they are asked to move their trunk backwards away from the wall. At the last point, the sternum notch and wall distance is measured again. The difference between the first and last measurements is recorded in centimeters. For the trunk lateral flexion measurement, the participant stands with their back to the wall. The tape measure is placed distal to the 3rd phalanx. The measure is recorded in centimeters. The measurement is repeated for the other side.

    From enrollment to the end of treatment at 6 weeks

  • Flexruler Measurement (kyphosis index)

    The kyphosis index will be calculated using the appropriate formula after the measurement with the flexible ruler. The flexible ruler is a metal covered with plastic, approximately 60 cm long, which can be molded according to the contour of the spine to measure the curves in the sagittal plane. To determine the kyphosis index, the spinous processes of the C7 and T12 vertebrae are determined as references and the participant's kyphosis shape is evaluated with the flexible ruler and transferred to paper. The kyphosis index is calculated by evaluating the angle formed between the distance between C7 and T12, defined as thoracic length, and the distance of the kyphosis peak, defined as thoracic width, to the thoracic length line.

    From enrollment to the end of treatment at 6 weeks

  • Inclinometer Tests

    Thoracic range of motion will be measured using an inclinometer for flexion and rotation (for the right and left sides). The spinous processes of the T1 and T12 vertebrae are marked as reference points. For the measurement of thoracic flexion, the inclinometer is placed vertically on the T1 vertebra and the participant is asked to lean forward so that the lumbar region does not participate in the movement. The value obtained at this point is recorded in degrees for the T1 vertebra flexion. Immediately afterwards, the inclinometer is placed vertically on the T12 vertebra and the T12 vertebra flexion is recorded in degrees. For thoracic right and left rotations, the inclinometer is placed horizontally on the T1 vertebra. The participant is asked to rotate the thoracic region and the value at the last point is recorded in degrees for the T1 vertebra. Immediately afterwards, the degree for the T12 vertebra is recorded.

    From enrollment to the end of treatment at 6 weeks

  • Scapula Protraction Test

    For the right and left scapula, the inferior edge of the scapula is determined and the vertical distance to the midline of the spine is measured with a tape measure and recorded in centimeters.

    From enrollment to the end of treatment at 6 weeks

  • Chest Circumference Measurement

    Respiratory capacity will be recorded in centimeters by taking the difference between the chest circumference measurements obtained at maximum inspiration and maximum expiration from the axillary, epigastric and subcostal regions. The greater the difference, the better the pulmonary function.

    From enrollment to the end of treatment at 6 weeks

  • the Quick Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

    The DASH is a questionnaire designed to assess disability resulting from upper extremity injuries, activity limitations, leisure activities, and work participation restrictions. The questionnaire consists of three sections. The first section contains 30 items: 21 items assessing difficulties in activities of daily living, 5 items assessing symptoms, and 4 items assessing social function, work, sleep, and self-esteem. This first section determines the Function/Symptom Model (DASH-FS) score. All questions are scored on a 5-point Likert-type scale (1: no difficulty, 5: cannot do at all) (0: no disability, 100: maximum disability). Scores range from 0 to 100 for each section (0: no disability, 100: maximum disability).

    From enrollment to the end of treatment at 6 weeks

  • SRS22 Patient Outcome Questionnaires

    Quality of life will be assessed with the Scoliosis Research Society Patient Questionnaire. The SRS-22 is a valid and reliable scoliosis-specific quality of life scale developed by Haher et al. and modified by the Scoliosis Research Society to assess the current perception of medical status and self-image in patients with idiopathic scoliosis. The scale consists of five subscales consisting of 22 questions, including pain, general body image, spine function, mental health, and treatment satisfaction. Participants rate each question on a scale of 1 (most negative) to 5 (most positive). Scores for each subscale range from 0 to 25, while the total score for treatment satisfaction ranges from 0 to 10. Higher scores on the scale indicate improved quality of life, while lower scores reflect decreased quality of life.

    From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Intervention arm

EXPERIMENTAL

1\. Posture Exercises (3 sets \* 15 reps): 1a) Shoulder lift 1b) Shoulder forward circles 1c) Shoulder backward circles 2. Pectoral Stretch Exercise (3 sets \* 10 reps; each stretch held for 30 seconds; for right and left sides) 3. Back Strengthening Exercise (3 sets \* 15 reps) 4. Self Mobilization Exercise (3 sets \* 10 reps; for right and left sides) 5. Cat-Camel Exercise (3 sets \* 10 reps) 6. Breathing Exercises (3 sets \* 10 reps): 6a) Diaphragmatic breathing 6b) Segmental breathing 7. Wall angels exercise (2 sets \* 10 reps)

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Control arm

ACTIVE COMPARATOR

1\. Posture Exercises (3 sets \* 15 reps): 1a) Shoulder lift 1b) Shoulder forward circles 1c) Shoulder backward circles 2. Pectoral Stretch Exercise (3 sets \* 10 reps; each stretch held for 30 seconds; for right and left sides) 3. Back Strengthening Exercise (3 sets \* 15 reps) 4. Self Mobilization Exercise (3 sets \* 10 reps; for right and left sides) 5. Cat-Camel Exercise (3 sets \* 10 reps) 6. Breathing Exercises (3 sets \* 10 reps): 6a) Diaphragmatic breathing 6b) Segmental breathing

Other: CONTROL

Interventions

Posture exercise, stretching exercise, breathing exercise, back strengthening exercise, self-mobilization exercise, cat camel exercise and postural correction exercise will be applied.

Intervention arm
CONTROLOTHER

Posture exercise, stretching exercise, breathing exercise, back strengthening exercise, self-mobilization exercise, cat camel exercise will be applied.

Control arm

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering to participate in the study and giving written consent
  • Being a woman/man between the ages of 18-25
  • Having a kyphotic posture

You may not qualify if:

  • Having a musculoskeletal disorder (scoliosis, etc.)
  • Having a neurological system disorder
  • Having a cardiopulmonary system disorder
  • Having a fracture or surgery related to the spine, rib cage, or upper extremity within the last year
  • Participating in an exercise program for kyphosis within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Demirel University Faculty of Health Science

Isparta, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kyphosis

Interventions

ExerciseDosage Forms

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Mesut Ergan, asst. prof.

    Suleyman Demirel University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 13, 2024

First Posted

January 1, 2025

Study Start

October 1, 2024

Primary Completion

October 3, 2024

Study Completion

January 20, 2025

Last Updated

January 1, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations