Therapeutic Exercises for Pain and Disability in Knee Osteoarthritis

NCT ID: NCT07128875

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-17
• Study Completion Date: 2026-07-17

Brief Summary

This study aims to evaluate the effectiveness of structured therapeutic exercises in reducing pain and disability among older adults diagnosed with knee osteoarthritis. The intervention will involve a supervised physical therapy program targeting muscle strength, joint mobility, and functional capacity. Participants will undergo 6 weeks of therapy, and improvements in pain and physical function will be measured using validated scales.

Detailed Description

Knee osteoarthritis (OA) is a leading cause of chronic pain and mobility limitations in the elderly population. Therapeutic exercises play a significant role in managing OA symptoms by strengthening the quadriceps, improving joint flexibility, and reducing stiffness. This study will enroll 60 participants aged 50-75 years diagnosed with knee OA. They will undergo a combination of strengthening, range of motion (ROM), and stretching exercises tailored to their condition. The intervention also includes adjunctive modalities such as hot pack and TENS to reduce pain and facilitate muscle engagement. Outcome measures will assess pain intensity, functional ability, and lower limb endurance before and after the intervention.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Exercise + TENS + Hot Pack

Participants in this group will receive a structured therapeutic exercise program designed to improve physical function and reduce pain in patients with knee osteoarthritis.

The session includes:

Warm-Up (10 min): Light walking or stationary cycling

Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension

Strengthening Exercises:

Quadriceps sets

Straight leg raises

Mini squats (within pain-free range)

Seated knee extensions using resistance bands

Stretching Exercises:

Hamstring stretch

Calf stretch

Quadriceps stretch

Cool Down (5-10 min): Breathing and relaxation techniques

Modalities:

Hot Pack: 15 minutes (applied pre- and post-exercise)

TENS: 10 minutes (applied pre- and post-exercise using dual-channel portable TENS unit - [Brand/Model, if available])

Group Type: EXPERIMENTAL

Exercise + TENS + Hot Pack

Intervention Type: OTHER

Therapeutic Exercises with Hot Pack and TENS This intervention focuses on improving physical function and reducing pain through structured therapeutic exercises for knee OA patients. The program includes Warm-Up (10 min): Light walking or stationary cycling. 2. Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension. 3. Strengthening Exercises:

Quadriceps sets Straight leg raises Mini squats (pain-free range)

Seated knee extensions with resistance band 4. Stretching Exercises:

Hamstring stretch Calf stretch Quadriceps stretch 5. Cool Down (5-10 min): Breathing and relaxation. 6. Hot Pack (15 min) + TENS (10 min): Applied pre and post exercises for pain relief and muscle relaxation.

Exercise Only (Control)

Participants in the control group will follow the same structured therapeutic exercise program as the experimental group. However, TENS will be replaced with a sham procedure that mimics device placement without electrical stimulation.

Warm-Up (10 min): Light walking or stationary cycling

Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension

Strengthening Exercises:

Quadriceps sets

Straight leg raises

Mini squats (within pain-free range)

Seated knee extensions using resistance bands

Stretching Exercises:

Hamstring stretch

Calf stretch

Quadriceps stretch

Cool Down (5-10 min): Breathing and relaxation techniques

Modalities:

Hot Pack: 15 minutes (if applicable)

Sham TENS: Electrodes applied without current

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

Warm-Up (10 min): Light walking or stationary cycling. 2. Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension. 3. Strengthening Exercises:

Quadriceps sets Straight leg raises Mini squats (pain-free range)

Seated knee extensions with resistance band 4. Stretching Exercises:

Hamstring stretch Calf stretch Quadriceps stretch 5.

Interventions

Exercise + TENS + Hot Pack

Therapeutic Exercises with Hot Pack and TENS This intervention focuses on improving physical function and reducing pain through structured therapeutic exercises for knee OA patients. The program includes Warm-Up (10 min): Light walking or stationary cycling. 2. Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension. 3. Strengthening Exercises:

Quadriceps sets Straight leg raises Mini squats (pain-free range)

Seated knee extensions with resistance band 4. Stretching Exercises:

Hamstring stretch Calf stretch Quadriceps stretch 5. Cool Down (5-10 min): Breathing and relaxation. 6. Hot Pack (15 min) + TENS (10 min): Applied pre and post exercises for pain relief and muscle relaxation.

Intervention Type: OTHER

Exercise

Warm-Up (10 min): Light walking or stationary cycling. 2. Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension. 3. Strengthening Exercises:

Quadriceps sets Straight leg raises Mini squats (pain-free range)

Seated knee extensions with resistance band 4. Stretching Exercises:

Hamstring stretch Calf stretch Quadriceps stretch 5.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosed with knee OA
• Aged 50-75 years
• Experiencing pain or functional limitation
• Able to attend supervised sessions
• Provided informed consent

Exclusion Criteria

• Severe cardiovascular or neurological conditions
• Acute injury or fracture in lower limb
• Uncontrolled hypertension or diabetes

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Nadeem Ahmad, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah international University Malakand Campus

Malakand, Kpk, Pakistan

Countries

Pakistan

Central Contacts

Dr.Nadeem Ahmad, MS

Role: CONTACT

n.ahmad@riphah.edu.pk

03451915105

Dr.Nadeem Ahmad, MS

Role: CONTACT

drnadeem765@gmail.com

03028367237

Other Identifiers

RIPHAH-REC Naimat ullah 01018

Identifier Type: -

Identifier Source: org_study_id