NCT04328155

Brief Summary

Sixty healthy individuals will be randomised into four groups. Group I (15 subjects) will be applied hotpacks, Group II (15 subjects) will be applied infrared, Group III will be applied ultrasound to hamstring muscles for 18 sessions 3 times per week and the subjects will do hamstring self stretching exercise 3 times for 15 seconds. Group IV will only do self stretching exercises. Outcome measures are Range of Motion and hamstring flexibility. Measurements will record before and after the end of the treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 22, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 26, 2020

Last Update Submit

March 9, 2021

Conditions

Keywords

electrophysical agentsstretching exerciseshamstring muscles

Outcome Measures

Primary Outcomes (2)

  • Changes of ROM

    Range of motion was measured by universal goniometer. Knee flexion and extension, Hip flexion, extension, external and internal rotation was measured

    baseline, after 6 weeks

  • Hamstring Flexibility

    Hamstring Flexibility was measured by universal goniometer by using active knee extension test.

    baseline, after 6 weeks

Study Arms (4)

Hotpack Group

EXPERIMENTAL

Group I (15 subjects) received 18 sessions hotpack to hamstring muscles and self stretching exercise3 times per week.

Procedure: Hotpack Group

Infrared Group

EXPERIMENTAL

Group II (15 subjects) received 18 sessions infrared to hamstring muscles and self stretching exercise3 times per week.

Procedure: Infrared Group

Ultrasound Group

EXPERIMENTAL

Group III (15 subjects) received 18 sessions ultrasound to hamstring muscles and self stretching exercise 3 times per week.

Procedure: Ultrasound Group

Control

ACTIVE COMPARATOR

Group IV (15 subjects) received 18 sessions self stretching exercise 3 times per week.

Procedure: Control

Interventions

Hotpack GroupPROCEDURE

Hotpack Group received 20 minutes hotpack to hamstring muscles region at prone position and participants stretched the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15 seconds .

Hotpack Group

Infrared Group received 20 minutes infrared to hamstring muscles region at prone position and participants stretchted the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15. seconds .

Infrared Group

Ultrasound Group received 5 minutes 1 M-Hz, 1,5 watt/cm2 ultrasound therapy to hamstring muscles region at prone position and participants stretched the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15 seconds .

Ultrasound Group
ControlPROCEDURE

Control Group participants stretched the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15 seconds .

Control

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being Student in Saraykoy Vocational School
  • Having Active Knee Extension degree lower than 60

You may not qualify if:

  • undergoing surgical operation for knee pathologies
  • history of trauma involving knee joint region
  • having a systemic and inflammatory disease targeting this region
  • pregnancy
  • malignancy
  • doing another exercise programme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sarayköy Vocational School

Denizli, 20300, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Sadler SG, Spink MJ, Ho A, De Jonge XJ, Chuter VH. Restriction in lateral bending range of motion, lumbar lordosis, and hamstring flexibility predicts the development of low back pain: a systematic review of prospective cohort studies. BMC Musculoskelet Disord. 2017 May 5;18(1):179. doi: 10.1186/s12891-017-1534-0.

  • Burke DG, Holt LE, Rasmussen R, MacKinnon NC, Vossen JF, Pelham TW. Effects of Hot or Cold Water Immersion and Modified Proprioceptive Neuromuscular Facilitation Flexibility Exercise on Hamstring Length. J Athl Train. 2001 Mar;36(1):16-19.

  • Brodowicz GR, Welsh R, Wallis J. Comparison of stretching with ice, stretching with heat, or stretching alone on hamstring flexibility. J Athl Train. 1996 Oct;31(4):324-7.

Study Officials

  • Atiye KAŞ ÖZDEMİR, Msc

    Sarayköy Vocational School Turan Mah. Jeotermal Sok. No:1 Sarayköy, Denizli

    STUDY CHAIR
  • Ummuhan BAŞ ASLAN, Prof .Dr.

    Pamukkale Univercity 20070 Kınıklı Denizli, Turkey

    STUDY CHAIR
  • Merve Bergin KORKMAZ, DR.

    Denizli State Hospital 20040 Denizli, Turkey

    STUDY CHAIR

Central Study Contacts

Ayşe Nur OYMAK SOYSAL, Dr.

CONTACT

Şule ŞİMŞEK, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel assingment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturar

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 31, 2020

Study Start

April 22, 2019

Primary Completion

April 25, 2020

Study Completion

August 28, 2021

Last Updated

March 10, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Because there is no web site to share my data

Locations