NCT07402447

Brief Summary

The aim of this study is to determine the effects of a combined quadriceps and calf strengthening program on gait, strength, pain, disability, functional mobility, and sleep quality in patients with knee osteoarthritis. A randomized controlled trial will be conducted at Hayatabad Medical Complex, Peshawar. A total of 52 participants aged 40-60 years with grade 2-3 knee osteoarthritis will be recruited using non-probability convenience sampling and randomly allocated into experimental and control groups. Outcome measures include Kinovea software for gait analysis, hand-held dynamometer for strength, Numeric Rating Scale for pain, WOMAC for disability, Timed Up and Go test for function, and Pittsburgh Sleep Quality Index for sleep quality. Data will be analyzed using SPSS version 27 employing repeated measures ANOVA and mixed-way ANOVA.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
8mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

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

Study Progress30%
Feb 2026Jan 2027

Study Start

First participant enrolled

February 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

February 4, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

Calf StrengtheningGaitSleep qualityQuadriceps Strengthening

Outcome Measures

Primary Outcomes (3)

  • Temporo-spatial Gait

    Gait parameters will be measured by Kinovea Software.A video of the gait will be recorded and then evaluated with kinovea.

    from baseline to 6 weeks

  • Quadriceps Strength

    the Hand Held Dynamometer will be used to asses the strength of quadriceps

    from baseline to 6 weeks

  • Calf Strength

    the Hand Held Dynamometer will be used to asses the strength of Calf

    from baseline to 6 weeks

Secondary Outcomes (4)

  • Knee Pain

    from baseline to 6 weeks

  • knee Disability

    from baseline to 6 weeks

  • knee Function

    from baseline to 6 weeks

  • Sleep Quality

    from baseline to 6 weeks

Study Arms (2)

Group A (Combined Quadriceps and Calf Strengthening)

EXPERIMENTAL

The experimental group will receive physiotherapy treatment consisting of the application of a heating pad for 10 minutes, followed by Grade II joint mobilization, quadriceps strengthening exercises, and calf strengthening exercises

Other: Group A (Combined Quadriceps and Calf Strengthening)

Group B (Conventional)

ACTIVE COMPARATOR

The control group will receive conventional physiotherapy treatment, which included the application of a heating pad for 10 minutes, followed by Grade II joint mobilization, and quadriceps strengthening exercises.

Other: Group B( Conventional)

Interventions

During weeks 1-2, Group A will receive a heating pad for 10 minutes followed by Grade II joint mobilization. This will be followed by strengthening exercises including quadriceps strengthening in the form of straight leg raises, quadriceps sets, and leg extension exercises with 1 kg weight. Calf strengthening exercises will also be performed, including standing heel raises, seated calf raises, and standing single heel raises with support. All exercises will be initially performed with 10 repetitions and 1 set. During weeks 3-4, the exercise protocol will progress by increasing the repetitions to 12, sets to 2, and external resistance to 1.5 kg. During weeks 5-6, further progression will be made by increasing the repetitions to 15, sets to 3, and external resistance to 2 kg.

Group A (Combined Quadriceps and Calf Strengthening)

During weeks 1-2, Group B will receive a heating pad for 10 minutes followed by Grade II joint mobilization. This will be followed by quadriceps strengthening in the form of straight leg raises, quadriceps sets, and leg extension exercises with 1 kg weight. All exercises will be initially performed with 10 repetitions and 1 set. During weeks 3-4, the exercise protocol will progress by increasing the repetitions to 12, sets to 2, and external resistance to 1.5 kg. During weeks 5-6, further progression will be made by increasing the repetitions to 15, sets to 3, and external resistance to 2 kg.

Group B (Conventional)

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both Male and Female
  • Participants aged 40-60years.
  • Diagnosed with grade 2 and 3 of knee osteoarthritis according to Kellgren-Lawrence
  • Quads manual muscle grading \<4
  • Ability to understand and comply with exercise instructions.

You may not qualify if:

  • History of recent knee surgery or trauma in the past six months.
  • Inflammatory joint diseases (e.g., rheumatoid arthritis, gout).
  • Severe cardiovascular or neurological disorders.
  • Uncontrolled hypertension or diabetes.
  • Participation in other physiotherapy or pharmacological interventions for knee OA during the study period.
  • Cognitive impairment or inability to follow commands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hayatabad Medical Complex

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, KneeSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Aisha Razzaq, PHD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 11, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations