Clinical trial NCT04528953: Investigating the Effect of Interval Walking and Qigong on People With Knee Osteoarthritis: Pilot Study
Official title: Investigating the Effect of Interval Walking and Qigong on Some Clinical and Biological Outcomes of People With Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 45
Sex: ALL
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis (KOA) causes pain and limited function that leads to a sedentary lifestyle. The sedentary lifestyle increases the risk of cardiovascular diseases. In addition, many subjects with KOA have knee pain and sleep disturbance that limit their function, quality of life and cause body fatigue. Walking exercise can benefit people with KOA. However, continues walking for more than 30 minutes can increase pain that may stop people from participation in walking exercise.

Interval walking may complete the same amount of walking exercise in several separate time periods, without causing extra pain in people with KOA. Mind-body exercise may improve sleep and pain in people with KOA.

This study will help researchers to find out whether the interval walking, or mind-body exercise may help people with KOA to improve their pain, fitness level, sleep quality, exercise participation, fatigue, and quality of life.

By doing this study, researchers hope to learn more about the interval walking or mind-body exercise in people with KOA.


Eligibility criteria: Inclusion criteria are the following:

1. 60-79 years of age and diagnosed with KOA by a physician or meet the ACR criteria (95% sensitivity, and 69% specificity) for KOA. The ACR criteria include experiencing almost daily knee pain and having at least 3 of these 6 criteria: (1) Age more than 50 years old, (2) less than 30 minutes of morning stiffness, (3) increased warmth of the knee, (4) crepitus with flexion or extension, (5) joints' bony enlargement , and (6) tenderness of joint line with palpation, or subject must be diagnosed radiologically, with grade II or more according to the Kellgren and Lawrence rating scale.
2. Frequent knee pain or aching on most of the preceding 30 days.
3. An average of mild to moderate pain intensity level (5 to 75 mm on the 100 mm VAS) in the last 7 days
4. Sedentary lifestyle assessed using 2011 Compendium of Physical Activities questionnaire. The subject is considered sedentary if engaging in exercise or physical activity with metabolic equivalents of task (MET) less than 4, not more than two times/week.

Exclusion criteria:

1. Unwilling to attend 3 sessions/week at Kirmayer Fitness Center
2. Having other types of arthritis such as rheumatoid arthritis or gout
3. Neurological disorders
4. CVD including hypertension that prevent them from engaging in walking exercise
5. Currently using beta blocker medication
6. Underwent any lower limb surgery during the past 6 months
7. A history of two or more incidents of fall during the last 6 months
8. Current hip or spine pain that prevents them from engaging in walking exercise.

Primary outcomes:
measure: Feasibility measurement: recruitment, compliance, and dropout
timeFrame: 6 week
measure: Acceptability
timeFrame: 6 week
Secondary outcomes:
measure: Comprehensive pain assessment: the Measure of Intermittent and Constant Osteoarthritis Pain
timeFrame: 6 week
measure: Resting heart rate (rHR) and heart rate recovery (HRR)
timeFrame: 6 week
measure: Heart rate variability (HRV)
timeFrame: 6 week
measure: Blood pressure
timeFrame: 6 week
measure: insomnia severity
timeFrame: 6 week
measure: Sleeping Quality: Pittsburgh Sleep Quality Index
timeFrame: 6 week
measure: Fatigue: Multidimensional Fatigue Inventory (MFI-20)
timeFrame: 6 week
measure: Depression: Geriatric Depression Scale
timeFrame: 6 week
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 6 week
measure: 36 short form Quality of Life
timeFrame: 6 week
measure: Inflammatory biomarkers
timeFrame: 6 week
measure: Fitness level- The 6-minute walk test
timeFrame: 6 week
measure: Pain intensity measurement
timeFrame: 6-week
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Wen Liu
state: Kansas
Study officials:
References: