NCT06750367

Brief Summary

Group A will be given Klapp method exercises to the participant for a period of 1 month twice in a week for 50min. Group B will be given printed information on an at-home exercise program, such, posture correction,corrective exercises and breathing exercises. They will be asked to perform the exercises twice weekly during the study and follow-up period. All these sessions will be of 50 minute for 2 session per week for 4 weeks

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

December 20, 2024

Last Update Submit

February 23, 2026

Conditions

Keywords

exercisespainposturefemaleself-efficacy

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale

    The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. moderate to good reliability for disability in patients with chronic musculoskeletal pain VAS is widely used as a measure of pain intensity in globally. It has been shown that VAS is valid, reliable and interval scale. The majority of the studies showed that visual analogue scale is a valid and reliable scale. . High reliability when it is used for acute musculoskeletal pain and ICC = 0.99 \[95%CI 0.989 to 0.992\], and moderate to good reliability for disability in patients with chronic musculoskeletal pain. Also, it is an interval scale. So, in clinical practice we can use this scale in case of measurement as an outcome measure tool.

    4th week

  • inclinometer

    The gravity-dependent (analogue) inclinometer produces angles that are comparable to the modified Cobb angle obtained from radiographs, establishing its criterion validity as a safe clinical tool for measuring thoracic kyphosis. Inclinometer has high validity with (r=0.85-0.95) and high inter-rater reliability (ICC=0.85-0.98)

    4th week

  • Self-efficacy breast feeding scale (BSES-S F questionnaire)

    Breastfeeding self-efficacy is defined as a mother's confidence in ability to breastfeed and predicts "whether a mother chooses to breastfeed, how much effort she will expend, whether she will persevere in her attempts until mastery is achieved, whether she will have self enhancing or self-defeating thought patterns, and how she will emotionally respond to breastfeeding difficulties" BSES (n = 5 studies) or BSES-SF (n = 36studies) among demographically or culturally diverse populations. All versions of the instrument demonstrated good reliability, with Cronbach's alphas ranging from .72 to .97

    4th week

Study Arms (2)

Klapp method exercises

EXPERIMENTAL

Four pointwalk followedby twopointwalk\&backwalk: This exercise is basic, it is a mobility exercise and always applied at the beginning of the program. Breathing exercise from a kneeling position: (raising hands with inhalation lowering hands with exhalation). Simple bounce glide with simultaneous breathing: (a stretching,strengthening and corrective exercises) Bunny hop: (for stretching and strengthening). Greeting: (Stretching and mobilization of thalamus)

Other: Klapp method exercises

At-Home exercises program

ACTIVE COMPARATOR

The researcher will prescribe stretching of neck, upper limb and thoracic region of participants as a baseline treatment. The control group will continue with their normal activities and pain relief methods. Additionally, they will be given printed information on an at-home exercise program, such corrective exercises (Chin tuck, stretching of neck extensor muscles and pectoral muscle groups in standing and supine positions) (16), posture correction exercises (This exercise program consisted of 2 strengthening (of the deep cervical flexors and shoulder retractors), and breathing exercises (Deep breathing is an exercise that can regulate breathing patterns and improve posture. The deep breathing that is done repeatedly can overcome stiffness in the thoracic cage and straighten the curve of thoracic kyphosis).They will be asked to perform the period of 1-month twice in a week for 50 min with10 repetitions of each exercise

Other: At-Home exercise program

Interventions

theywill begiven printed information on an at-home exercise program, such corrective exercises (Chin tuck, stretchingof neck extensormuscles andpectoral musclegroups instandingandsupinepositions) (16) ,posturecorrection exercises(Thisexerciseprogramconsistedof2strengthening(of thedeep cervical flexorsandshoulderretractors)(26) ,andbreathingexercises(Deep breathing is an exercise that can regulate breathing patterns and improve posture. The deep breathing that is done repeatedly can overcome stiffness in the thoracic cage and straighten the curve of thoracic kyphosis)(27).Theywillbeaskedtoperformtheperiodof1month twiceinaweekfor50minwith10repetitionsofeachexercise.

At-Home exercises program

The researcher will administer Klapp method exercises to the participant for a period of 1 month (twice in a week for 50 min .The researcher will perform stretching of upper limb, neck and thoracic region to the participants as a baseline treatment. Klapps exercises program include four point walk followed by two point walk and back walk, breathing exercise from kneeling position, breathing exercise from quadrapedal position, simple bounce glide with simulanteos breathing, bunny hop greeting. Each exercise will be performed with 10 repetitions

Klapp method exercises

Eligibility Criteria

Age22 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbreast feeding females with kyphotic posture
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous females
  • Female who had C-Section
  • Lactating females (females who have had feed their babies for last 6 months)
  • Pain in neck (pain score 4-6 in visual analogue scale)
  • Female with kyphotic angle greater than 45 degrees (assess by inclinometer)

You may not qualify if:

  • history of orthopedic surgery (spinal fusion)
  • orthopedic disorder (disk degeneration, osteoporosis)
  • history of vertebral fracture
  • Female who had given vaginal birth
  • Breast feeding issues (lactation failure, nipple failure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Civil hospital and Al-siddique hospital

Sialkot, Punjab Province, 6400, Pakistan

Location

Related Publications (5)

  • Zappala M, Lightbourne S, Heneghan NR. The relationship between thoracic kyphosis and age, and normative values across age groups: a systematic review of healthy adults. J Orthop Surg Res. 2021 Jul 9;16(1):447. doi: 10.1186/s13018-021-02592-2.

    PMID: 34243795BACKGROUND
  • Zanguie H, Yousefi M, Ilbiegi S, Pezeshk AF. Validity and Reliability of Non Invasive Methods for Evaluating Kyphosis and Lordosis Curvatures: A Literature Review. Journal of Modern Rehabilitation. 2023

    BACKGROUND
  • Shafshak TS, Elnemr R. The Visual Analogue Scale Versus Numerical Rating Scale in Measuring Pain Severity and Predicting Disability in Low Back Pain. J Clin Rheumatol. 2021 Oct 1;27(7):282-285. doi: 10.1097/RHU.0000000000001320.

    PMID: 31985722BACKGROUND
  • Sebaaly A, Silvestre C, Rizkallah M, Grobost P, Chevillotte T, Kharrat K, Roussouly P. Revisiting thoracic kyphosis: a normative description of the thoracic sagittal curve in an asymptomatic population. Eur Spine J. 2021 May;30(5):1184-1189. doi: 10.1007/s00586-020-06670-7. Epub 2020 Nov 22.

    PMID: 33222002BACKGROUND
  • Urrutia J, Besa P, Narvaez F, Meissner-Haecker A, Rios C, Piza C. Mid and lower thoracic kyphosis changes during adulthood: the influence of age, sex and thoracic coronal curvature. Arch Orthop Trauma Surg. 2022 Aug;142(8):1731-1737. doi: 10.1007/s00402-021-03798-z. Epub 2021 Feb 5.

    PMID: 33544182BACKGROUND

MeSH Terms

Conditions

Breast FeedingMotor ActivityPain

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • hina gul, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2024

First Posted

December 27, 2024

Study Start

August 1, 2024

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations