NCT04475874

Brief Summary

The purpose of this study was to assess the effect of active stretching exercises on reducing pain and the quality of life during menstrual cycle in young adult females.

Trial Health

87
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
Completed

Started Feb 2019

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

February 10, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

July 12, 2020

Last Update Submit

July 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS)

    Visual Analog Scale measures pain intensity it is a unidimensional measure of pain intensity The classification of VAS was done according to pain scores (mild: 1-3 Moderate: 4-7 Severe: 8-10)

    Change from Baseline at pain intensity 4 weeks after

Secondary Outcomes (1)

  • Verbal Multidimensional System(VMS)

    Change from Baseline amenstruation characteristics 4 weeks after

Study Arms (3)

supervised stretching exercises :group A

ACTIVE COMPARATOR

The intervention group A practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks

Other: supervised stretching exercises

non-supervised active stretching home program: group B

ACTIVE COMPARATOR

practiced non-supervised active stretching home program

Other: non-supervised active stretching home program

Standard of care: group c

NO INTERVENTION

control group

Interventions

30 to 45-minute supervised active stretching program by a trained physical therapist, three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations

Also known as: home program stretching exercises
supervised stretching exercises :group A

non supervised 30 to 45-minute supervised active stretching program three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations

Also known as: home program of stretching exercises
non-supervised active stretching home program: group B

Eligibility Criteria

Age18 Years - 23 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI of 20-29.9 kg/m2,
  • regular menstrual cycle
  • length 28-30 day
  • cycle bleed from 3 to 7 days,

You may not qualify if:

  • contraindication to stretching exercise
  • taking any hormonal medications:
  • smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zizi Mohammed Ibrahim Ali

Riyadh, Nnjkjk, 2136, Saudi Arabia

Location

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
PRINCIPAL INVESTIGATOR
PI Title
ASSOCIATE PROF

Study Record Dates

First Submitted

July 12, 2020

First Posted

July 17, 2020

Study Start

February 10, 2019

Primary Completion

January 12, 2020

Study Completion

February 12, 2020

Last Updated

July 17, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations