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HIGH AND LOW INTENSITY PROGRESSIVE RESISTED EXERCISES ON PAIN, RANGE OF MOTION AND FUNCTIONAL DISABILITY

Primary Purpose

Osteo Arthritis Knee, Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
HIGH INTENSITY PROGRESSIVE RESISTED EXERCISE
LOW INTENSITY PROGRESSIVE RESISTED EXERCISE
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring osteoarthritis, Sarcopenia

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both genders.
  • Age range between 35-65 years
  • Diagnosed osteoarthritis patients of grade I to III according to kellgren & Lawrence on X-ray (diagnosed by orthopedic specialist)
  • Diagnosed patients with sarcopenia according to SARC-F questionnaire. (diagnosed by orthopedic specialist)

Exclusion Criteria:

  • Patients with history of trauma like RTA(road traffic accident)

    , fall history and other loading injuries, patellar fracture or dislocation.

  • Patients with history of surgery (meniscal reconstruction, TKR(total knee replacement) or Partial Knee Replacement etc.)
  • Patients with severe patellofemoral osteoarthritis.

Sites / Locations

  • University of Lahore Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High intensity

Low intensity

Arm Description

Intervention: Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform.Routine physical therapy including TENS, Hot pack and Deep friction massage along with high intensity exercises will also be delivered along with Muscle Energy Technique. Experimental:High intensity will be treated with high intensity exercises in such a way that 1st and 2nd week; resistance training will be of 50% 1RM with 4 sets of 10 repetitions. 3rd and 4th week: resistance training will be of 70% 1RM with 4 sets of 10 repetitions. 5th and 6th week: the training will be of 80% 1RM with 4 sets of 10 repetitions Last 4 sessions will be: 7th and 8th week: resistance training will be of 80% 1RM with 5 sets of 10 repetitions.

Intervention: Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform.Routine physical therapy including TENS, Hot pack and Deep friction massage along with Low intensity exercises will also be delivered along with Muscle Energy Technique. Experimental:Low intensity Group B will be treated with low intensity exercise in such a way that, 1st and 2nd week; Resistance training will be of 20% 1RM with 4 sets of 15 reps 3rd and 4th week Resistance training will be of 30% 1RM with 4 sets of 15 reps 5th and 6th week: the training will be of 40% 1RM with 4 sets of 15 reps Last session will be: 7th and 8th week; Training of 40% 1RM with 5 sets of 15 reps

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS)
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain
Knee injury and Osteoarthritis Outcome Score (KOOS)
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL)
Range of motion
Range of motion is the extent of movement of a joint, measured in degrees of a circle. Universal goniometer (UG) will be used to evaluate range of motion (ROM)

Secondary Outcome Measures

Full Information

First Posted
December 30, 2021
Last Updated
December 30, 2021
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05190380
Brief Title
HIGH AND LOW INTENSITY PROGRESSIVE RESISTED EXERCISES ON PAIN, RANGE OF MOTION AND FUNCTIONAL DISABILITY
Official Title
COMPARATIVE EFFECTS OF HIGH AND LOW INTENSITY PROGRESSIVE RESISTED EXERCISES ON PAIN, RANGE OF MOTION AND FUNCTIONAL DISABILITY IN KNEE OSTEOARTHRITIS PATIENTS WITH SARCOPENIA: A RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
July 8, 2022 (Anticipated)
Study Completion Date
July 18, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will be randomized controlled trial. This study will be conducted in University of Lahore Teaching Hospital, Lahore, Pakistan. A sample size of 84 will be randomly allocated into two experimental groups, (42 participants in each group), by computer generated random number list. The participants,randomly allocated to the experimental group A, will receive high intensity resisted exercises ,in addition with routine physical therapy as TENS (transcutaneous electrical nerve stimulator), Hot pack, Deep friction massage Each session will be of 35-45 minutes with 5 minutes warm up, 35 minutes for training session and lastly 5 minutes for cool down • Participants in experimental group B, will receive Low intensity resisted exercises in addition with routine physical therapy
Detailed Description
Recruitment: Participants will be recruited and referred by orthopedic doctor, University of Lahore Teaching Hospital to Physical Therapy Department. The study will be randomized controlled trial. This study will be conducted in University of Lahore Teaching Hospital, Lahore, Pakistan. A sample size of 84 will be randomly allocated into two experimental groups, (42 participants in each group), by computer generated random number list. The participants,randomly allocated to the experimental group A, will receive high intensity resisted exercises ,in addition with routine physical therapy as TENS, Hot pack, Deep friction massage Participants in experimental group B, Low intensity resisted exercises in addition with routine physical therapy Both experimental groups will receive sixteen treatment sessions and those will be given over a period of eight weeks (2 sessions per week, each session of 35-45 minutes with 5 minutes warm up and lastly 5 minutes for cool down in both groups. Outcome measure will be taken by assessor at baseline, and at the end of 8th week (at the end of last treatment session) through Numeric pain rating scale and KOOS Randomization and Allocation: Afterwards, participants confirming the eligibility criteria will be randomly allocated, through computer generated random number list , into two experimental groups (Group A, Group B). Blindness: Study will be single, assessor blinded and an independent investigator will perform randomization and will inform the patients and therapist about the allocation. Intervention: Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform. Duration: Sixteen treatment sessions will be given over a period of eight weeks (2 sessions per week, each session of 35-45 minutes). Outcome Variables and Measures Pain (Numeric pain rating scale) Functional disability (KOOS) ROM (Universal Goniometer) Outcome measures will be taken at baseline and at the end of last treatment session i.e. 8th week. Collected data will be than analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Sarcopenia
Keywords
osteoarthritis, Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High intensity
Arm Type
Experimental
Arm Description
Intervention: Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform.Routine physical therapy including TENS, Hot pack and Deep friction massage along with high intensity exercises will also be delivered along with Muscle Energy Technique. Experimental:High intensity will be treated with high intensity exercises in such a way that 1st and 2nd week; resistance training will be of 50% 1RM with 4 sets of 10 repetitions. 3rd and 4th week: resistance training will be of 70% 1RM with 4 sets of 10 repetitions. 5th and 6th week: the training will be of 80% 1RM with 4 sets of 10 repetitions Last 4 sessions will be: 7th and 8th week: resistance training will be of 80% 1RM with 5 sets of 10 repetitions.
Arm Title
Low intensity
Arm Type
Experimental
Arm Description
Intervention: Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform.Routine physical therapy including TENS, Hot pack and Deep friction massage along with Low intensity exercises will also be delivered along with Muscle Energy Technique. Experimental:Low intensity Group B will be treated with low intensity exercise in such a way that, 1st and 2nd week; Resistance training will be of 20% 1RM with 4 sets of 15 reps 3rd and 4th week Resistance training will be of 30% 1RM with 4 sets of 15 reps 5th and 6th week: the training will be of 40% 1RM with 4 sets of 15 reps Last session will be: 7th and 8th week; Training of 40% 1RM with 5 sets of 15 reps
Intervention Type
Other
Intervention Name(s)
HIGH INTENSITY PROGRESSIVE RESISTED EXERCISE
Intervention Description
Intervention:Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform. Both groups will receive routine physical therapy (Tens, Hot pack, Deep friction massage) in addition with experimental interventions
Intervention Type
Other
Intervention Name(s)
LOW INTENSITY PROGRESSIVE RESISTED EXERCISE
Intervention Description
Intervention:Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform. Both groups will receive routine physical therapy (Tens, Hot pack, Deep friction massage) in addition with experimental interventions
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain
Time Frame
8 weeks
Title
Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL)
Time Frame
8 weeks
Title
Range of motion
Description
Range of motion is the extent of movement of a joint, measured in degrees of a circle. Universal goniometer (UG) will be used to evaluate range of motion (ROM)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both genders. Age range between 35-65 years Diagnosed osteoarthritis patients of grade I to III according to kellgren & Lawrence on X-ray (diagnosed by orthopedic specialist) Diagnosed patients with sarcopenia according to SARC-F questionnaire. (diagnosed by orthopedic specialist) Exclusion Criteria: Patients with history of trauma like RTA(road traffic accident) , fall history and other loading injuries, patellar fracture or dislocation. Patients with history of surgery (meniscal reconstruction, TKR(total knee replacement) or Partial Knee Replacement etc.) Patients with severe patellofemoral osteoarthritis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Haider Ullah Khan, MS PTN
Phone
03314127210
Email
haiderullah@live.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ashfaq Ahmad, Phd
Phone
03009449192
Email
hod@uipt.uol.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saiqa Kanwal, MS-MSK*
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Lahore Teaching Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
55150
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Waqar Afzal, Phd*
Phone
03214668377
Email
waqar.afzal@uipt.uol.edu.pk
First Name & Middle Initial & Last Name & Degree
Saiqa Kanwal, MS-MSK*
First Name & Middle Initial & Last Name & Degree
Syed Asadullah Arslan, Phd
First Name & Middle Initial & Last Name & Degree
Bilal umar, BSPT, DPT,Phd

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32033882
Citation
Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
Results Reference
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PubMed Identifier
32424600
Citation
Pickering ME, Chapurlat R. Where Two Common Conditions of Aging Meet: Osteoarthritis and Sarcopenia. Calcif Tissue Int. 2020 Sep;107(3):203-211. doi: 10.1007/s00223-020-00703-5. Epub 2020 May 18.
Results Reference
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PubMed Identifier
27813347
Citation
Bade MJ, Struessel T, Dayton M, Foran J, Kim RH, Miner T, Wolfe P, Kohrt WM, Dennis D, Stevens-Lapsley JE. Early High-Intensity Versus Low-Intensity Rehabilitation After Total Knee Arthroplasty: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Sep;69(9):1360-1368. doi: 10.1002/acr.23139. Epub 2017 Aug 13.
Results Reference
background
PubMed Identifier
33591346
Citation
Messier SP, Mihalko SL, Beavers DP, Nicklas BJ, DeVita P, Carr JJ, Hunter DJ, Lyles M, Guermazi A, Bennell KL, Loeser RF. Effect of High-Intensity Strength Training on Knee Pain and Knee Joint Compressive Forces Among Adults With Knee Osteoarthritis: The START Randomized Clinical Trial. JAMA. 2021 Feb 16;325(7):646-657. doi: 10.1001/jama.2021.0411.
Results Reference
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PubMed Identifier
32664548
Citation
Liao CD, Chiu YS, Ku JW, Huang SW, Liou TH. Effects of Elastic Resistance Exercise on Postoperative Outcomes Linked to the ICF Core Sets for Osteoarthritis after Total Knee Replacement in Overweight and Obese Older Women with Sarcopenia Risk: A Randomized Controlled Trial. J Clin Med. 2020 Jul 11;9(7):2194. doi: 10.3390/jcm9072194.
Results Reference
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PubMed Identifier
15924620
Citation
Thorstensson CA, Roos EM, Petersson IF, Ekdahl C. Six-week high-intensity exercise program for middle-aged patients with knee osteoarthritis: a randomized controlled trial [ISRCTN20244858]. BMC Musculoskelet Disord. 2005 May 30;6:27. doi: 10.1186/1471-2474-6-27.
Results Reference
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PubMed Identifier
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Citation
Shorter E, Sannicandro AJ, Poulet B, Goljanek-Whysall K. Skeletal Muscle Wasting and Its Relationship With Osteoarthritis: a Mini-Review of Mechanisms and Current Interventions. Curr Rheumatol Rep. 2019 Jun 15;21(8):40. doi: 10.1007/s11926-019-0839-4.
Results Reference
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HIGH AND LOW INTENSITY PROGRESSIVE RESISTED EXERCISES ON PAIN, RANGE OF MOTION AND FUNCTIONAL DISABILITY

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