NCT04919486

Brief Summary

Degenerative knee arthritis is the most common chronic arthritis disease. Once the elderly suffer from this disease, it will accelerate the loss of body function and autonomy. strength performances and maintain are the most important functional performances of lower extremities, especially in walking and balance in daily activities for elderly people with osteoarthritis(OA) of the knee. However, combining the exercise and visual feedback may promote the muscle strength and functional performances of lower limbs, facilitating the muscle strength, motor and boady functional performances for elderly adults after OA knee. Therefore, the purpose of this proposal is to investigate the changes in muscle strength and physical fitness of lower limbs in older adults following OA knee after visual feedback non-weight bearing exercise intervention.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 25, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2020

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2021

Completed
Last Updated

June 9, 2021

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

July 29, 2020

Last Update Submit

June 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    The scale is mainly to trace the patient's subjective perception of the knee joint within 48 hours. There are 24 questions, divided into three aspects: pain (5 questions, 0-20 points), stiffness (2 questions, 0-8 points) , Functional activities (17 questions, 0-68 points), each item is divided into five levels: none, minor, moderate, severe, and very severe. The total of the three parts is 0-96 points.

    5 minutes

Secondary Outcomes (1)

  • MicroFets3 to measure hip and knee muscle strength

    20 minutes

Study Arms (2)

Experiment group

EXPERIMENTAL

non-weight bearing visual feedback intervention under the of Labview software, and used rowing machine equipment for exercise training for 30 minutes,then eselastic band exercise training for 30 minutes.

Behavioral: visual feedback with non-weight bearing exercise

elastic band exercise

ACTIVE COMPARATOR

elastic band exercise under the Physiotherapist, and used elastic band for exercise training for 60 minutes,include muscles flexion the hip joint, muscles extention the hip joint,etc.

Behavioral: elastic band exercise

Interventions

the training time is 12 weeks, twice a week, 60 minutes each time, a total of 24 times.

Experiment group

the training time is 12 weeks, twice a week, 60 minutes each time, a total of 24 times.

elastic band exercise

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Clinical diagnosis of degenerative knee arthritis.
  • Must be able to stand up and sit down.

You may not qualify if:

  • surgery on the knee or hip joint.
  • rheumatoid arthritis and uarthritis in past six years.
  • lower limb fractures
  • neurological diseases,e.g.,stroke、parkinson's disease
  • injected hyaluronic acid into the knee joint in the past two months
  • severe cardiovascular and heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei

Taipei, Taiwan

RECRUITING

Related Publications (1)

  • Lin PL, Yu LF, Kuo SF, Wang XM, Lu LH, Lin CH. Effects of computer-aided rowing exercise systems on improving muscle strength and function in older adults with mild knee osteoarthritis: a randomized controlled clinical trial. BMC Geriatr. 2022 Oct 21;22(1):809. doi: 10.1186/s12877-022-03498-2.

MeSH Terms

Conditions

Osteoarthritis

Interventions

Feedback, Sensory

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalFeedback, PhysiologicalHomeostasisPhysiological Phenomena

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

July 29, 2020

First Posted

June 9, 2021

Study Start

July 25, 2020

Primary Completion

July 25, 2021

Study Completion

July 25, 2021

Last Updated

June 9, 2021

Record last verified: 2020-07

Locations