NCT05807009

Brief Summary

the purpose of this study is to investigate the effect of core exercises on health status, pain, pressure pain thresholds and functional capacity in patients with FM

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

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

December 28, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
Last Updated

April 10, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 28, 2023

Last Update Submit

March 28, 2023

Conditions

Keywords

fibromyalgia syndromecore exerciseaerobic exercisepressure pain threshold

Outcome Measures

Primary Outcomes (1)

  • pressure pain thresholds

    pressure algometer will be used for assessment of pressure pain threshold

    up to 8 weeks

Secondary Outcomes (3)

  • pain intensity

    up to 8 weeks

  • health status

    up to 8 weeks

  • function state

    up to 8 weeks

Study Arms (1)

core exercise

EXPERIMENTAL

the patients will receive seven core exercises two times a week for eight weeks

Other: core exerciseOther: traditional therapy

Interventions

the patients will receive seven exercises performed in crook lying and side lying position on exercise mats. Cushions were used to allow the participants to be comfortable in all positions. The exercises in the crook lying position were core activation with breathing, single-leg lift with knees bent, single-leg slides, bridging and knee drop sideways. The exercises completed in side lying included hip external rotation with knees bent and hip abduction with knees straight.

core exercise

the patients will receive : an active warm-up including low intensity movements and dynamic stretching; choreographed aerobic training, progressing gradually from low to moderate intensity; and a cool-down involving low intensity movements, and dynamic and static stretching

Also known as: aerobic exercise
core exercise

Eligibility Criteria

Age21 Years - 43 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Patient referred from rheumatologist with a history of widespread bilateral musculoskeletal pain both above and below the waist for a minimum of three months and pain in at least 11 of 18 specific tender points 2. moderate or greater tenderness reported on digital palpation with 4 kg/cm2 of force 3. 21\_43 years old patients

You may not qualify if:

  • \- 1. presence of other systemic, somatic, or psychiatric diseases. 2. pregnant or were planning a pregnancy during the study period. 3. patients with acute disease including high fever and uncontrolled medical conditions (such as severe infection and cardiovascular disease including unstable angina.
  • \. surgical history for previous 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Engy Ashraf Gamal Mohamed

Giza, 11251, Egypt

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: core exerscie
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 10, 2023

Study Start

December 28, 2022

Primary Completion

February 28, 2023

Study Completion

March 28, 2023

Last Updated

April 10, 2023

Record last verified: 2023-03

Locations