NCT04509830

Brief Summary

this study will be conducted to investigate the role of hip strengthening in improving dynamic knee stability, gait parameter, lower extremity strength and disability in knee osteoarthritis

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
88

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable knee-osteoarthritis

Status
unknown

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

August 3, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

8 months

First QC Date

August 3, 2020

Last Update Submit

December 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • dynamic knee stability

    dynamic knee stability will be measured by frontal plane projection angle

    baseline

Study Arms (2)

hip strengthening

EXPERIMENTAL

resistance training for hip abductor, hip extensor, and hip external rotator will be performed.cuff weights will be used with 80% of 1 repetition maximum at 3 sets of 8 repetitions with 10-15 second rest between repetitions and 1-2 minute rest between sets.

Other: hip strengtheningOther: quadriceps strengthening, stretch hamstring,cuff muscles

quadriceps strengthening, stretch for hamstring,cuff muscles

ACTIVE COMPARATOR

quadriceps strengthening: multi-angle isometric exercise from sitting position will be performed. cuff weights will be used with 3 sets of 12 repetitions at 40% of 1 reprtition maximum. self stretch for hamstring and cuff muscles from supine position. the procedure will be repeated 4 times.

Other: quadriceps strengthening, stretch hamstring,cuff muscles

Interventions

resistance training for hip abductor, hip extensor, and hip external rotator

hip strengthening

multi-angle isometric quadriceps strengthening and hamstring and cuff self stretch

hip strengtheningquadriceps strengthening, stretch for hamstring,cuff muscles

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 40 to 65 years grade 2-3 on KL grade BMI 25 to 32 kg/m2 medial KOA

You may not qualify if:

  • lateral KOA intraarticular corticosteriod injection into knee within pervious 3 months significant comorbidity individuals with known hip osteoarthritis previous trauma affection one or both hips history of other medical conditions affecting the knee joint previous replacement of any joint in the lower extremity low back pain cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of physiotherapy department at Benha fever hospital

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 12, 2020

Study Start

January 1, 2021

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

December 30, 2020

Record last verified: 2020-12