NCT03050320

Improving Resilience and Longevity for Workers Through Exercise

Completed NA Results posted Last updated 10 August 2018

What this trial tests

NA trial testing Exercise in Osteoarthritis, Knee in 43 participants. Completed in 30 June 2017.

Timeline

8 February 2017

Primary endpoint
30 June 2017

30 June 2017

Quick facts

Lead sponsor	McMaster University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	43
Start date	8 February 2017
Primary completion	30 June 2017
Estimated completion	30 June 2017
Sites	1 location across Canada

Drugs / interventions tested

• Exercise
• No Exercise

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →
• Osteoarthritis, Hip — all drugs for Osteoarthritis, Hip →

Sponsor

McMaster University

Who can join

Eligibility, any sex, with Osteoarthritis, Knee or Osteoarthritis, Hip. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Lower Extremity Functional Scale Primary · Weeks 1 and 13

The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. Each item is scored from 0 (extreme difficulty or unable to perform activity), to 4 (no difficulty to perform activity). The minimum possible score is 0, and the maximum possible score is 80. Scores closer to 80 represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures

Group	Value	95% CI
Exercise	5.3	± 9.0
No Exercise	-1.6	± 8.5

Change in Self-reported Knee and Hip Pain Secondary · Weeks 1 and 13

Change in self-reported knee and hip pain will be assessed with 3 valid and reliable questionnaires: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Hip disability and Osteoarthritis Outcome Score (HOOS), and the Intermittent and Constant Osteoarthritis Pain (ICOAP) score. The KOOS and HOOS pain scores represent a normalized score from 0 (extreme symptoms) to 100 (no symptoms). KOOS and HOOS scores closer to 100 indicate fewer symptoms. The ICOAP consists of two sub-scales: constant pain (5 items) and intermittent pain (6 items). The score from each subscale represents a normalize

KOOS Pain

Group	Value	95% CI
Exercise	3.3	± 7.2
No Exercise	-0.1	± 3.8

HOOS Pain

Group	Value	95% CI
Exercise	5.4	± 12.3
No Exercise	2.1	± 6.7

ICOAP Constant Pain

Group	Value	95% CI
Exercise	-0.8	± 10.0
No Exercise	0.2	± 4.0

ICOAP Intermittent Pain

Group	Value	95% CI
Exercise	-6.1	± 15.5
No Exercise	-2.4	± 9.0

ICOAP Total

Group	Value	95% CI
Exercise	-3.6	± 11.4
No Exercise	-1.2	± 5.9

Change in Self-reported Upper Extremity Pain Secondary · Weeks 1 and 13

The Disabilities of the Arm Shoulder and Hand is a 30-item questionnaire addressing upper extremity physical function and symptoms. The DASH is suitable for people with any upper limb musculoskeletal disorders and can also monitor changes in severity of symptoms and functional abilities over time. Each item is scored from 1 (no difficulty) to 5 (unable). Total scores range from 0 to 100, with higher scores indicating more upper limb problems.

Group	Value	95% CI
Exercise	-1.6	± 5.4
No Exercise	0.2	± 4.1

Change in Isometric Knee Extensor and Flexor Strength Secondary · Weeks 1 and 13

The peak torque developed during knee extension and flexion during a maximum isometric contraction will be measured by use of a ergoFET hand-held dynamometer.

Extension

Group	Value	95% CI
Exercise	0.15	± 0.29
No Exercise	0.00	± 0.28

Flexion

Group	Value	95% CI
Exercise	0.07	± 0.11
No Exercise	0.00	± 0.14

Change in Grip Strength Secondary · Weeks 1 and 13

Grip strength will be assessed using a Jamar hand dynamometer. The hand dynamometer will be set to a fixed position and all values of grip force will be expressed in kg.

Dominant hand

Group	Value	95% CI
Exercise	-0.4	± 5.5
No Exercise	0.9	± 5.1

Non-dominant hand

Group	Value	95% CI
Exercise	-0.9	± 4.9
No Exercise	1.6	± 3.4

Change in Cardiovascular Fitness Secondary · Weeks 1 and 13

Cardiovascular fitness will be calculated using the Single Stage Treadmill Walking Test. Predictions of VO2max will be made from heart rate (measured with a heart rate monitor), walking speed, age and gender.

Group	Value	95% CI
Exercise	1.0	± 1.9
No Exercise	0.1	± 1.8

Change in Mobility Performance (Six-Minute Walk Test) Secondary · Weeks 1 and 13

Mobility performance will be measured using the Six-Minute Walk Test (6MWT). For this test, participants are instructed to walk as far as possible in 6 minutes. The distance covered in 6 minutes is recorded in metres. This measure has produced reliable and valid data in persons with knee OA.

Group	Value	95% CI
Exercise	36.8	± 51.6
No Exercise	18.4	± 29.6

Change in Mobility Performance (Stair Ascent and Descent) Secondary · Weeks 1 and 13

Mobility performance will be measured using the Stair Ascent and Descent Test. For this test, the time taken to ascend, as well as descend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.

Stair Ascent

Group	Value	95% CI
Exercise	-0.5	± 0.8
No Exercise	-0.1	± 0.5

Stair Descent

Group	Value	95% CI
Exercise	-0.6	± 1.1
No Exercise	0.0	± 0.5

Change in Mobility Performance (30-second Chair Stand Test) Secondary · Weeks 1 and 13

Mobility performance will be measured using the 30-second Chair Stand Test. This test measures the number of times participants can rise and lower from a standard height chair, without using arm rests, in a 30-second period.This measure has produced reliable and valid data in persons with knee OA.

Group	Value	95% CI
Exercise	3.5	± 3.2
No Exercise	1.6	± 2.9

Change in Resilience Secondary · Weeks 1 and 13

Resilience will be measured using the Resilience Scale 25 Survey, which is a 25-item questionnaire designed to evaluate a participants ability to adapt to stress and adversity. The test is scored out of 175 (scores ranging from 25 to 175), with higher scores indicating higher resilience.

Group	Value	95% CI
Exercise	8.6	± 10.5
No Exercise	3.3	± 9.6

Change in Work Ability Secondary · Weeks 1 and 13

The Work Ability Index (WAI) is a widely-used self-report questionnaire that evaluates a worker's capacity to perform a job accounting for their physical and mental well-being in addition to the demands of their job. The WAI consists of seven dimensions including current work ability relative to life-time best, work ability related to job demands, number of current physician-diagnosed health conditions, estimated work impairment due to the conditions, sick leave over the past year, own prognosis, and mental resources. Total scores range from 7 to 49 and can fall under one of four classificatio

Group	Value	95% CI
Exercise	0.9	± 3.3
No Exercise	0.6	± 2.9

Change in Depressive Symptoms Secondary · Weeks 1 and 13

Depression will be assessed with the Centre of Epidemiological Studies Depression (CES-D) Scale, a 20-item scale developed for the general population with emphasis on affect. Elements of affect include mood, guilt, worthlessness, helplessness, appetite, and sleep. Each item is scored from 0 (rarely or none of the time), to 3 (most of the time). The items are summed to produce a total score between 0 and 60 with a score of 16 or higher indicating depression.

Group	Value	95% CI
Exercise	1.0	± 4.8
No Exercise	-0.1	± 4.5

Sponsor's own description

The purpose of this study is to examine the impact of an OA-specific aerobic and strengthening exercise program, delivered within the workplace, on mobility, pain, physical capacity, and resilience among workers with knee or hip OA as well as those with no joint pain. The investigators hypothesize that exercise designed for OA, delivered at work, will improve all of these outcomes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exercise for osteoarthritis of the knee.
   Lawford BJ, Hall M, Hinman RS, Van der Esch M, et al · · 2024 · cited 37× · PMID 39625083 · DOI 10.1002/14651858.cd004376.pub4