Knee OsteoarthritisNCT05745649
Restoration of Physical Function in Patients Following Total Knee Replacement: Comparison Between Resistive Strength Training Exercises & Ankle Weights
A study testing Resistance exercises and Ankle weights in people with Knee Osteoarthritis, run by Neuro Counsel Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Techniques used to restore the physical functions in TKR patients Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Resistance exercises and Ankle weights
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Dec 2022to 16 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of patients above 40 years with total knee arthroplasty
- 4-6 weeks following TKR
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Techniques used to restore the physical functions in TKR patients
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Resistance exercises, Ankle weights
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercisesOther
Resistance exercises
Ankle weightsOther
Ankle weights
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Resistive exercise Receives: Other: Resistance exercises |
| group B | Active comparator | Ankle weights Receives: Other: Ankle weights |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
zero means no pain and 10 means worst type of pain
Measured: 6 weeks
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
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start16 Dec 2022
- Primary completion15 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single blind RCT in which two groups were formulated. One as Control and other as an experimental
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuro Counsel Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745649
- Sponsor's protocol ID
- 340
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Physical Function in Patients Following Total Knee Replacement: Comparison Between Resistive Strength Training Exercises & Ankle Weights
- ClinicalTrials.gov ID
- NCT05745649
- Acronym / sponsor ID
- 340
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Neuro Counsel Hospital, PakistanUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A single blind RCT in which two groups were formulated. One as Control and other as an experimental
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Resistance exercisesResistive exercise |
| group B | Active comparator | Other: Ankle weightsAnkle weights |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of patients above 40 years with total knee arthroplasty
- 4-6 weeks following TKR
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exercisesResistance exercises | Other | Group A |
| Ankle weightsAnkle weights | Other | group B |
Primary outcome
Numeric Pain Rating Scale
Time frame: 6 weeks
zero means no pain and 10 means worst type of pain
Short form 36 Quality of life
Time frame: 6 week
on zero to 100 scale. minimum means low quality of life and higher values mean better quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: Undecided. We have not decided yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercises and Ankle weights in people with Knee Osteoarthritis, run by Neuro Counsel Hospital, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.