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

Sarcopenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05190380
• Other study ID #: IRB-UOL-FAHS/981/2021
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2021
• Est. completion date: July 18, 2022

Study information

• Verified date: December 2021
• Source: University of Lahore
• Contact: Muhammad Haider Ullah Khan, MS PTN
• Phone: 03314127210
• Email: haiderullah[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 1. Pain (Numeric pain rating scale) 2. Functional disability (KOOS) 3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: July 18, 2022
• Est. primary completion date: July 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Sarcopenia

Intervention

Other:
• HIGH INTENSITY PROGRESSIVE RESISTED EXERCISE
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
• LOW INTENSITY PROGRESSIVE RESISTED EXERCISE
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

Locations

Country	Name	City	State
Pakistan	University of Lahore Teaching Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

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. — View 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. — View 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). pii: E2194. doi: 10.3390/jcm9072194. — View 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 weeks
Primary	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)	8 weeks
Primary	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)	8 weeks