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Restoration of Physical Function in Patients Following Total Knee Replacement: Comparison Between Resistive Strength Training Exercises & Ankle Weights

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Resistance exercises
Ankle weights
Sponsored by
Neuro Counsel Hospital, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age of patients above 40 years with total knee arthroplasty 4-6 weeks following TKR Exclusion Criteria: Age less than 40 patients Concurrent medical disease that could affect the progress (e.g., uncontrolled hypertension, advanced malignancy, decompensated cardiovascular disease. Pain score more than 6/10

Sites / Locations

  • Rawal General & Dental Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

group B

Arm Description

Resistive exercise

Ankle weights

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
zero means no pain and 10 means worst type of pain
Short form 36 Quality of life
on zero to 100 scale. minimum means low quality of life and higher values mean better quality of life

Secondary Outcome Measures

Full Information

First Posted
February 16, 2023
Last Updated
March 10, 2023
Sponsor
Neuro Counsel Hospital, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT05745649
Brief Title
Restoration of Physical Function in Patients Following Total Knee Replacement: Comparison Between Resistive Strength Training Exercises & Ankle Weights
Official Title
Restoration of Physical Function in Patients Following Total Knee Replacement: Comparison Between Resistive Strength Training Exercises & Ankle Weights
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
February 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuro Counsel Hospital, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Techniques used to restore the physical functions in TKR patients
Detailed Description
to restore the physical functions in TKR patients by the use of ankle weights and resistance exercises. Total 40 patients were included in this study and two groups had been formulated one as experimental and other as control. 2 sessions were given to each group for 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A single blind RCT in which two groups were formulated. One as Control and other as an experimental
Masking
Participant
Masking Description
A single blind RCT
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Resistive exercise
Arm Title
group B
Arm Type
Active Comparator
Arm Description
Ankle weights
Intervention Type
Other
Intervention Name(s)
Resistance exercises
Intervention Description
Resistance exercises
Intervention Type
Other
Intervention Name(s)
Ankle weights
Intervention Description
Ankle weights
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
zero means no pain and 10 means worst type of pain
Time Frame
6 weeks
Title
Short form 36 Quality of life
Description
on zero to 100 scale. minimum means low quality of life and higher values mean better quality of life
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age of patients above 40 years with total knee arthroplasty 4-6 weeks following TKR Exclusion Criteria: Age less than 40 patients Concurrent medical disease that could affect the progress (e.g., uncontrolled hypertension, advanced malignancy, decompensated cardiovascular disease. Pain score more than 6/10
Facility Information:
Facility Name
Rawal General & Dental Hospital
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44010
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We have not decided yet

Learn more about this trial

Restoration of Physical Function in Patients Following Total Knee Replacement: Comparison Between Resistive Strength Training Exercises & Ankle Weights

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