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Table 3 Analysis outline for primary and secondary analysis

From: Efficacy of pre-operative quadriceps strength training on knee-extensor strength before and shortly following total knee arthroplasty: protocol for a randomized, dose-response trial (The QUADX-1 trial)

Variable/outcome

Hypothesis

Outcome measure (unit, scale)

Methods of analysis

Descriptive statistics (sample characteristics)

 

Age, weight, height, side of index knee (continuous and dichotomous)

Summary statistics

Primary analysis

 Primary outcome

1. Change in isometric knee-extensor strength Δt0-t1

Group 2 < Group 4

Group 4 ≈ Group 6

Change in Nm/kg (continuous)

Analysis of variance ANOVAa

Secondary analysis

 Secondary outcomes

2. Change in isometric knee-extensor strength Δt0-t2, Δt0-t3

Group 2 < Group 4

Group 4 ≈ Group 6

Change in Nm/kg (continuous)

ANOVAa

3. Change in Knee Osteoarthritis Outcome Score (KOOS) subscales Δt0-t1, Δt0-t3

Group 2 < Group 4

Group 4 > Group 6

Change in questionnaire subscales (continuous)

ANOVAa

4. Change in Oxford Knee Score (OKS) Δt0-t1, Δt0-t3

Group 2 < Group 4

Group 4 > Group 6

Change in questionnaire (continuous)

ANOVAa

5. Change in 6-Minute Walking Test for distance (6MWT) Δt0-t1, Δt0-t2, Δt0-t3

Group 2 < Group 4

Group 4 > Group 6

Change in meters walked (continuous)

ANOVAa

6. Change in Stair Climb Test (SCT) Δt0-t1, Δt0-t2, Δt0-t3

Group 2 < Group 4

Group 4 > Group 6

Change in time used to ascend and descend stairs (continuous)

ANOVAa

7. Change in current knee pain (Numeric Rank Scale, NRS) Δt0-t1, Δt0-t2, Δt0-t3

Group 2 < Group 4

Group 4 > Group 6

Change in NRS 0–10 (continuous)

ANOVAa

8. Change in knee pain during the last week (Numeric Rank Scale, NRS) Δt0-t1, Δt0-t3

Group 2 < Group 4

Group 4 > Group 6

Change in NRS 0–10 (continuous)

ANOVAa

9 Distribution in need for surgery

Group 2 < Group 4

Group 4 > Group 6

Yes, don’t know, no

Summary statistics

 Other outcomes

10. Difference in adherence to intervention between groups

Group 2 > Group 4

Group 4 > Group 6

Group 2 > Group 6

We hypothesize differences between groups in adherence (%) to the training intervention (i.e., higher number of sessions per week, the lower adherence (%))

Number of sessions, sets, repetitions and time-under-tension

ANOVAa

  1. aIf data are not normally distributed the non-parametric Kruskal-Wallis test will be used
  2. Analysis of variance: (ANOVA)