Introduction
Background and rationale
Objectives
Methods
Study design and setting
Participants and recruitment
Randomisation, allocation concealment and blinding
Sample size determination
Procedure and data collection
Domain | Outcome measure | Time point for data collection |
---|---|---|
Safety | Major adverse cardiac and cerebral events | 6 months |
Cognition | Baseline, 14 weeks, 6 months | |
Quality of recovery | Postoperative Quality of Recovery Scale [24] | Baseline, 1 day, 3 days, 6 days, 2 weeks, 8 weeks, 14 weeks and 6 months |
Cardiovascular | Lung capacity [25] Heart rate Oxygen saturation Blood pressure | Baseline, 2 weeks, 8 weeks, 14 weeks and 6 months |
Physical health | Weight Waist circumference Body mass index | Baseline, 2 weeks, 8 weeks, 14 weeks and 6 months |
Strength | Isometric knee flexion strength Isometric knee extension strength Hand grip strength [26] | 2 weeks, 8 weeks, 14 weeks and 6 months |
Balance | 2 weeks, 8 weeks, 14 weeks and 6 months | |
Independence | Instrumental Activities of Daily Living scale [29] | Baseline, 14 weeks and 6 months |
Upper limb impairment | Functional Difficulties Questionnaire [30] | Baseline, 2 weeks, 8 weeks, 14 weeks and 6 months |
Sternal stability | Sternal ultrasound [31] Sternal Instability Scale [34] | 2 weeks, 8 weeks, 14 weeks and 6 months |
Participant satisfaction | Patient perception questions [35] | 14 weeks |
Withdrawals and replacements
Exercise intervention
Moderate-intensity resistance training group
Exercise | Target muscle group(s) | Sets x Reps | Intensity | Progression | |
---|---|---|---|---|---|
Weeks 1–6 | |||||
1 | Knee extension* | Quadriceps | 1 × 9–12 | RPE 13–16/20 | Progressed by 5–10% of the initial weight until patients are able to exercise within the desired range (RPE 13/20 or volitional fatigue after 9–12 repetitions) |
2 | Knee flexion* | Hamstrings | |||
3 | Bicep curl | Biceps | |||
4 | Lateral raise | Deltoids | |||
5 | Triceps pushdown | Triceps | |||
6 | Back extension** | Lumbar extensors | |||
7 | Neck extension | Cervical extensors | |||
Weeks 7–12 | |||||
1 | Leg Press | Gluteals, hamstrings and quadriceps | 1 × 9–12 | RPE 13–16/20 | Progressed by 5–10% of the initial weight until patients are able to exercise within the desired range (RPE 13/20 or volitional fatigue after 9–12 repetitions) |
2 | Hip abduction | Hip abductors | |||
3 | Hip adduction | Hip adductors | |||
4 | Latissimus pulldown | Latissimus dorsi | |||
5 | Shoulder press | Deltoids and trapezius | |||
6 | Seated row | Latissimus dorsi, trapezius, deltoids | |||
7 | Bicep curl | Biceps | |||
8 | Lateral raise | Deltoids | |||
9 | Triceps pushdown | Triceps | |||
10 | Back extension** | Lumbar extensors | |||
11 | Neck extension | Cervical extensors |
Standard care group
Outcome measures
Primary outcome
Secondary outcomes
Grade of motion | Modified Sternal Instability Scale |
---|---|
0 | Clinically stable sternum (no detectable motion)—normal |
1 | Minimally separated sternum (slight increase in motion upon special testing*) |
2 | Partially separated sternum—regional (moderate increase in motion upon special testing*) |
3 | Completely separated sternum—entire length (marked increase in motion upon special testing*) |