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

Not Applicable

• Conditions: Sarcopenia; Osteo Arthritis Knee
• Interventions: Other: HIGH INTENSITY PROGRESSIVE RESISTED EXERCISE; Other: LOW INTENSITY PROGRESSIVE RESISTED EXERCISE

• Registration Number: NCT05190380
• Lead Sponsor: University of Lahore

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

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.

Study Timeline

• Study Start: 2021-11-10
• Status Verified: 2021-12
• Study First Submitted: 2021-12-30
• Study First Submitted QC: 2021-12-30
• Last Update Submitted: 2021-12-30
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13
• Primary Completion: 2022-07-08
• Study Completion: 2022-07-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity	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.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.
Low intensity	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.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

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale (NPRS)	8 weeks	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
Range of motion	8 weeks	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)
Knee injury and Osteoarthritis Outcome Score (KOOS)	8 weeks	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)

Trial Locations

Locations (1)

University of Lahore Teaching Hospital; 🇵🇰 Lahore, Punjab, Pakistan