Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05319964
• Other study ID #: E2-21-1004
• Status: Completed
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: February 10, 2024

Study information

• Verified date: May 2024
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to compare the effects of anti-gravity treadmill training and traditional treadmill training treatments combined with strengthening exercises on patients' pain levels, quality of life, distal femoral cartilage thickness, and functional capacity in patients with moderate and severe knee OA. In addition, it was aimed to compare the compliance of the patients to aerobic exercise.

Description:

Patients with moderate to severe OA have persistent pain that significantly affects their functional status, activity participation, and quality of life. As with mild OA, non-pharmacological interventions that focus on education, exercise, and weight management are first-line treatments for patients with moderate to severe knee OA.

Exercise is recommended for all patients with moderate to severe knee OA to reduce pain and protect the joint. A meta-analysis showed that exercise has beneficial effects on pain, even in patients with severe disease and awaiting total knee replacement.

The aim of this study was to compare the effects of anti-gravity treadmill training and traditional treadmill training treatments combined with strengthening exercises on patients' pain levels, quality of life, distal femoral cartilage thickness, and functional capacity in patients with moderate and severe knee OA. In addition, it was aimed to compare the compliance of the patients to aerobic exercise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 10, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Female patients = 50 and = 75 years old

• Patients with a diagnosis of knee OA in at least one knee according to the classification criteria of the American College of Rheumatology

• Patients with Kellgren-Lawrence (K-L) knee OA staging III to IV

• Patients reporting knee pain on most days of the past month

• Patients with stable medical and psychological status

• Patients willing to participate in the study

Exclusion Criteria:

Patients with serious cardiovascular, pulmonary, neurological disease or other musculoskeletal problems (inflammatory rheumatic disease, active synovitis, severe low back pain, hip/knee joint replacement or other hip/knee-related trauma, fracture, or surgery) that impair walking

• Patients with a history of corticosteroid injection to the knee in the last 3 months

• Patients who have received opioid analgesics or systemic corticosteroids in the last 3 months

• Patients who have undergone any exercise program or physical therapy program for the lower extremities in the last 3 months

• Patients with severe vision, hearing and language problems

• Patients with a body mass index =35 kg /m²

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Anti-gravity treadmill
Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, 3 days a week for 8 weeks. Participants were provided 30 minutes anti-gravity treadmill sessions including a 5 minutes warm - up and cool - down period for each session, 3 days a week, for 8 weeks
• Conventional treadmill
Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound 3 days a week for 8 weeks. The moderate-intensity aerobic exercise program will be performed for 30 minutes at an intensity of 65-80% of the maximum heart rate, consisting of a 5-minute warm-up and cool-down period.
• Control
Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound 3 days a week for 8 weeks.

Locations

Country	Name	City	State
Turkey	Gaziler Physical Therapy and Rehabilitation Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale for Pain (VAS-pain)	Pain intensity will be evaluated with a visual analog scale (0-10mm) that has proven validity and reliability to measure musculoskeletal pain.	Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks
Secondary	WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Score	It measures knee pain, stiffness, and physical function. Scores for each subscale are summed with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. The sum of the scores of the three subscales gives the WOMAC score. High scores are associated with more pain, stiffness, and dysfunction, while low scores indicate well-being.	Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks
Secondary	Short Form Health Survey 36 (SF-36)	SF-36 includes 36 items used to assess the quality of life of patients with chronic pain. It measures eight different domains that address physical function, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation, and mental health. The score for each domain ranges from 0 (worse quality of life) to 100 (best quality of life).	Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks
Secondary	Six-minute walk test (6MWT)	The 6 Minute Walk Test is a submaximal exercise test that usually corresponds to 80% of a person's maximum heart rate and is used to evaluate functional capacity and treatment response.	Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks
Secondary	Femoral cartilage thickness measurement with ultrasound	Distal femoral cartilage thickness will be evaluated by the same investigator, blinded to the patient treatment groups, using an ultrasound device with a 7.5-12 MHz linear transducer (LOGIQ 7 Pro; GE Yokogawa Medical System, Tokyo, Japan) available in our clinic.	Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks