NCT06268925

Brief Summary

it will be 8 week zoom program of exercises for knee osteo arthritis. participant will be selected according to elegibilty criteria. pre and post measurements will be obtained. then feasibility and efficacy will be assesed.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

February 22, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

December 2, 2023

Last Update Submit

February 16, 2024

Conditions

Keywords

TelerehabilitationFeasibilityEfficacySri Lanka

Outcome Measures

Primary Outcomes (2)

  • Efficacy of telerehabilitation program

    measured by attrition rate which is the measure of screened individual who are eligible but refused to participate and proportion of screened individuals who enrolled in to the study

    post 8 weeks of exercise program

  • Feasibility and acceptability

    asking patients "how satisfied they are about tele rehabilitation program" respectively at 8 weeks post.

    post 8 week

Secondary Outcomes (3)

  • lower extremity muscle strength and dynamic balance

    pre and post 8 week of exercise program

  • pain,

    Pre and post 8 weeks of exercise program

  • pain stiffness and physical activity

    pre and post 8 week of exercise program

Study Arms (1)

Study group

EXPERIMENTAL

single arm group exercises will be given to the patients

Other: Exercises

Interventions

number of exercises will be guided to do through zoom

Study group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet National Institute for Health and Care Excellence clinical criteria for OA
  • Age ≥45 years.
  • Activity-related knee joint pain.
  • Morning knee stiffness ≤ 30 min.
  • Report history of knee pain ≥ 3mths.
  • Report knee pain on most days of the past month.
  • Report an average pain score of at least 4 on an 11-point numeric rating scale during walking over the previous week.
  • Report difficulty walking and climbing stairs.
  • Have access to a device with internet connection: if they can use without assistance if possible

You may not qualify if:

  • On waiting list for/planning knee/hip surgery in next 12 months.
  • Previous arthroplasty on affected knee.
  • Recent knee surgery (past 6 months).
  • Consulting/ed physiotherapy or doing strengthening exercise for knee (past 6 months).
  • Self-reported inflammatory arthritis (eg rheumatoid arthritis).
  • Any neurological condition affecting lower limbs; and/or any unstable/uncontrolled cardiovascular condition.
  • Clearance to participate from a general practitioner will be required for anyone who reported a fall (past 12 months) or is house-bound due to immobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M.S.F.Sarjana

Puttalam, North Western Province, 61300, Sri Lanka

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic 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: 14 people with knee osteoarthritis will be recruited and conducted group classes through zoom
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 2, 2023

First Posted

February 20, 2024

Study Start

February 22, 2024

Primary Completion

April 22, 2024

Study Completion

May 3, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations