NCT06319976

Brief Summary

Purpose of the study:

  • To investigate the effect of rotator cuff training on hand grip strength in adults with different body mass index.
  • To investigate the effect of rotator cuff training on hand grip static endurance in adults with different body mass index.
  • To investigate the effect of rotator cuff training on hand grip dynamic endurance in adults with different body mass index.
  • To investigate the effect of rotator cuff training on upper limb function in adults with different body mass index.

Trial Health

35
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 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

March 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 30, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

March 13, 2024

Last Update Submit

March 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hand grip strength

    The JAMAR Hydraulic hand dynamometer is used to measure hand grip strength in (Kg) , It will be evaluated before and after training for each subject in both groups. Each subjects will be asked to grasp the handle with the dominant hand and perform hand grip with maximum effort only during exhalation and after a verbal cue given by the examiner " one, two, three, go". The subjects will be instructed to maintain maximum contraction for 5 seconds. Three measurements will be taken with a rest interval of 60 seconds between trials in order to avoid muscle fatigue during the assessment and the average of the three measurements will be calculated to measure hand grip strength.

    up to six weeks

Secondary Outcomes (3)

  • Hand grip static endurance

    up to six weeks

  • Hand grip dynamic endurance

    up to six weeks

  • Upper limb function

    up to six weeks

Study Arms (2)

open chain exercises for rotator cuff muscles and advices for postural correction

EXPERIMENTAL

Group will be subdivided into three subgroups according to their body mass index to normal, over weight and obese type1. All subjects will receive open chain exercises for rotator cuff muscles and advices for postural correction.

Other: open chain exercises for rotator cuff musclesOther: Advices for postural correction

Advices for Postural correction

ACTIVE COMPARATOR

Group will be subdivided into three subgroups according to their body mass index to normal, over weight and obese type1. All subjects will receive advices for postural correction. .

Other: Advices for postural correction

Interventions

open chain exercises for rotator cuff muscles, three times per week for six weeks.

open chain exercises for rotator cuff muscles and advices for postural correction

Advices for postural correction like neutral position of head and neck, aliening the shoulder and hip and using a foot stool to rest the feet.

Advices for Postural correctionopen chain exercises for rotator cuff muscles and advices for postural correction

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult Subjects of both genders their ages between (18 : 35) years old.
  • Body mass index between (18.5 : 34.9 ) Kg/ m2.
  • Dominant hand is the right hand.

You may not qualify if:

  • The subjects will be excluded if they have:
  • Traumatic conditions of the upper limb.
  • Previous orthopedic disorders or neurological deficit of the upper limb.
  • Previous surgery of the upper limbs.
  • Any sensory problems.
  • Neuromuscular disease like multiple sclerosis.
  • Pregnancy.
  • Cancer Patients.
  • Subjects under chemotherapy.
  • Immunodeficiency diseases.
  • Psychological disorders (depression - anxiety).
  • Chronic diseases as (diabetes - hypertension).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Amir Saleh, Professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Nada Atef, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator at department of basic science , Cairo university

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 20, 2024

Study Start

April 30, 2024

Primary Completion

October 30, 2024

Study Completion

December 30, 2024

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL