Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover

Comparative Resistance Exercise Effect on Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01245283

Enrollment

Registered

2010-11-22

Start date

2010-11-30

Completion date

2013-06-30

Last updated

2014-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

knee, osteoarthritis, pain, function, impairment

Brief summary

The purpose of this study is to determine if a 4 month resistance exercise program can reduce knee osteoarthritis pain functional impairment and cartilage turnover.

Interventions

OTHERConcentric Focused Resistance Exercise

Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.

OTHERnormal activities and clinical care

Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines

OTHEREccentric Focused Resistance Exercise

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Osteoarthritis (OA) of the knee for \>6 months * moderate to severe pain immediately following a 50-foot walk * knee pain primarily due to tibiofemoral OA and not from patellofemoral OA * bilateral standing anterior-posterior radiograph demonstrating grade 2 or 3 OA of the target knee * willing and able to participate in regular exercise for four months * free from musculoskeletal limitations that would preclude resistance exercise participation * free of abnormal cardiovascular responses during the screening graded maximal walk test

Exclusion criteria

* unable to walk * regular resistance exercise training (\>3X week) within the past 6 months * specific low back pain or acute back injury * spinal stenosis that precludes walking one block due to neurogenic claudication * any major injury to either knee within the prior 12 months * any surgery to either knee within the last 12 months * lumbar radiculopathy * vascular claudication * significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in either knee * have had corticosteroid or viscosupplement injections within three months of study participation * have added new over the counter or prescription pain medication within two months of study participation

Design outcomes

Primary

Measure	Time frame	Description
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months	Baseline, 4 Months	The WOMAC is a standard, multidimensional, self-administered functional-health status instrument for patients with lower limb OA. Subjects will complete the self-assessment at the time intervals indicated to document any change in their perception of their functional health status. Scale for Total score: the higher score means the worst the function and pain Total WOMAC scores will have a range of 0 to 96 (best and worst scores possible). 0-20 Womac pain (0= best, 20=worst) 0-8 Womac stiffness (0= best, 8=worst) 0-68 Womac functional (0= best, 68=worst) 0-96 Womac Total (0= best, 96=worst)

Secondary

Measure	Time frame	Description
Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months	Baseline, 4 Months	Functional abilities related to moving body weight will be captured using two standard tests, the chair rise time and stair climb time. Subjects will complete the tests at the time intervals indicated to document any change in their functional abilities.
Leg Press Test; Change From Baseline at 4 Months	Baseline, 4 Months	Each participant will do a one repetition maximum. Participants will perform a leg press. The leg press is a weight training exercise in which the individual pushes a weight or resistance away from them using their legs.
Leg Extensions Test; Change From Baseline at 4 Months	Baseline, 4 Months	Each participant perform a one repetition maximum . Participants will perform a leg extension which is a resistance weight training exercise that targets the quadriceps muscle in the legs. The exercise is done using a machine called the Leg Extension Machine. This resistence is measured in pounds.
Six Minute Walk Test; Change From Baseline at 4 Months	Baseline, 4 Months	Each participant will walk at a self-selected pace in the lab around a pre-measured loop for a period of six minutes. Subjects will complete the walk test at the time intervals indicated to document any change. 6 minute walk test is a baseline and 4 month post intervention measurement. It is used to measure distance covered while walking during 6 minutes.
Chest Press; Change From Baseline at 4 Months	Baseline, 4 Months	Each participant will perform a one repetition maximum. Participants will perform a chest press which is an upper body strength training exercise that consists of pressing a weight upwards from a supine position. This resistence is measured in pounds.
Shoulder Press Test; Change From Baseline at 4 Months	Baseline, 4 Months	Each participant will perform a one repetition maximum. Participants will perform the shoulder press which is a weight training exercise, typically performed while standing, in which a weight is pressed straight upwards from the shoulders until the arms are locked out overhead. This resistence is measured in pounds.
Seated Row Test; Change From Baseline at 4 Months	Baseline, 4 Months	Each participant will perform a one repetition maximum. Participants will do a seated row test which is pulling on a cable to lift weight from a seated row position. This resistence is measured in pounds.
Leg Curl Test; Change From Baseline at 4 Months	Baseline, 4 Months	Each participant will perform a one repetition maximum. Participant will perform a leg curl which is an isolation exercise that targets the hamstring muscles. The exercise involves flexing the lower leg against resistance towards the buttocks. This resistence is measured in pounds.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Wait-list Non-exercise Control (CON) Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group. normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines	32
Concentric Focused RX (CRX) Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press. Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.	28
Eccentric Focused RX (ERX) The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while assistance is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press. Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.	30
Total	90

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	14	11	11

Baseline characteristics

Characteristic	Wait-list Non-exercise Control (CON)	Concentric Focused RX (CRX)	Eccentric Focused RX (ERX)	Total
Age, Continuous	68.9 years STANDARD_DEVIATION 7.1	69.5 years STANDARD_DEVIATION 6.5	66.8 years STANDARD_DEVIATION 5.4	68.27 years STANDARD_DEVIATION 6.45
Region of Enrollment United States	32 participants	28 participants	30 participants	90 participants
Sex: Female, Male Female	22 Participants	19 Participants	21 Participants	62 Participants
Sex: Female, Male Male	10 Participants	9 Participants	9 Participants	28 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	2 / 32	2 / 28	1 / 30
serious Total, serious adverse events	0 / 32	0 / 28	1 / 30

Outcome results

Primary

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months

The WOMAC is a standard, multidimensional, self-administered functional-health status instrument for patients with lower limb OA. Subjects will complete the self-assessment at the time intervals indicated to document any change in their perception of their functional health status. Scale for Total score: the higher score means the worst the function and pain Total WOMAC scores will have a range of 0 to 96 (best and worst scores possible). 0-20 Womac pain (0= best, 20=worst) 0-8 Womac stiffness (0= best, 8=worst) 0-68 Womac functional (0= best, 68=worst) 0-96 Womac Total (0= best, 96=worst)