NCT07034534

Brief Summary

The study aimed to determine if yoga poses and conventional physiotherapy were more effective than deep breathing exercises and conventional physiotherapy in reducing kinesiophobia in amateur football players with chronic ankle instability. 28 participants were divided into an experimental and control group, with the experimental group receiving yoga poses and conventional physiotherapy, and the control group receiving deep breathing exercises and conventional physiotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

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 26, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

May 17, 2025

Last Update Submit

June 19, 2025

Conditions

Keywords

Chronic ankle instabilityKinesio phobiaMind body practiceYoga posesDeep breathing techniqueConventional physiotherapyPhysical and emotional stability

Outcome Measures

Primary Outcomes (2)

  • Cumberland ankle instability tool (CAIT)

    Cumberland ankle instability tool (CAIT) is a 9-item and 30 points; self-report measures the severity of functional ankle instability. Each item has responses scored with different point values (ranging typically from 0 to 3 or 0 to 5). Total score is 30. The score from 27 to 30 represent normal stability, and the scores less than 27 representing ankle instability.

    Baseline and week 6

  • Tampa scale for kinesiophobia

    Tampa scale is a 17-item self-reported instrument used to distinguish between non-excessive fear and phobia in patients with chronic musculoskeletal pain, i.e., the fear of movement. Each item is a 4 -point scale anchored from 1 (strongly disagree) to 4 (strongly agree) with total score of 68. The Score 17 and below representing (no kinesiophobia) and for a participants from score 37- 68 (represents kinesiophobia).

    Baseline and week 6

Secondary Outcomes (2)

  • Pain anxiety symptom scale

    Baseline and week 6

  • Y-balance test

    Baseline and week 6

Study Arms (2)

Three typical yoga poses and conventional physiotherapy

ACTIVE COMPARATOR

Participants received three typical yoga poses and conventional physiotherapy for five days each, for a total of six weeks with rest periods.

Behavioral: Three typical yoga posesBehavioral: Deep breathing technique

Deep Breathing technique and conventional physiotherapy

ACTIVE COMPARATOR

Participants received Deep Breathing technique and conventional physiotherapy for five days each, for a total of six weeks with rest periods..

Behavioral: Three typical yoga posesBehavioral: Deep breathing technique

Interventions

duration for both group includes 10 mins 5 sec, rest period will be included

Also known as: conventional physiotherapy
Deep Breathing technique and conventional physiotherapyThree typical yoga poses and conventional physiotherapy

duration for both group includes 10 mins 5 sec, rest period will be included

Also known as: conventional physiotherapy
Deep Breathing technique and conventional physiotherapyThree typical yoga poses and conventional physiotherapy

Eligibility Criteria

Age18 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18 - 22
  • Acute ankle sprain diagnosis: documented diagnosis of chronic ankle instability.
  • Chronic ankle instability pain score of 0-27 on CAIT tool
  • Kinesio phobia severity score: 37-68 on Tampa scale
  • Pain anxiety symptom scale (PASS) score: 67-94

You may not qualify if:

  • Neurological problem
  • Recent history of ankle surgery
  • Proscribed with any pain - relieving medication
  • Both ankle instability and acute injuries to musculoskeletal structures in the lower limb.
  • Participants who have multiple fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saveetha Institute of Medical and Technical Sciences

Chennai, Tamil Nadu, 602105, India

Location

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary investigator

Study Record Dates

First Submitted

May 17, 2025

First Posted

June 24, 2025

Study Start

August 26, 2023

Primary Completion

October 6, 2024

Study Completion

February 20, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Locations