McNeely 2008a.

Study characteristics
Methods	Study design: RCT Number randomized: 52; 27 to the exercise group and 25 to the control group Study start and stop dates: recruitment from October 1, 2005 to October 31, 2006 Length of intervention: 12 weeks Length of follow‐up: to end of the intervention
Participants	Type cancer: HNC Cancer stage, n (%): exercise group: Stage I, 2 (7%); Stage II, 3 (11%); Stage III, 9 (33%); Stage IV, 12 (44%) control group: Stage I, 1 (4%); Stage II, 3 (12%); Stage III, 3 (12%); Stage IV, 18 (72%) Time since cancer diagnosis: not reported Time beyond active treatment, median (range) months: exercise group: 12 (2 to 120) months control group: 17 (2 to 180) months Inclusion criteria: surgical treatment, including radical neck dissection, modified radical neck dissection, and other variants of selective neck dissection KPS score of at least 60% no evidence of residual cancer in the neck and no distant metastasis completion of adjuvant HNC treatment symptoms of shoulder dysfunction attributed to spinal accessory nerve damage, with ≥ 3 of the following signs: atrophy of the upper trapezius muscle shoulder droop scapular misalignment winging of the scapula with elevation of the arm limitation in shoulder abduction range of motion Eligibility criterion related to interest or ability to exercise, or both: none reported Exclusion criteria: history of shoulder or neck pathology unrelated to cancer treatment comorbid medical illness or psychiatric illness that would prevent completion of treatment or interfere with follow‐up Gender, n (%): exercise group: men, 20 (74%); women, 7 (26%) control group: men, 17 (68%); women, 8 (32%) Current age, mean (range) years: exercise group: 53 (32 to 76) years control group: 57 (43 to 76) years Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level, completed university, n (%): exercise group: completed university, 12 (44%) control group: completed university, 14 (56%) Income, > USD80,000/year: exercise group: > USD80,000/year, 9 (33%) control group: > USD80,000/year, 12 (48%) SES, on disability, n (%): exercise group: on disability, 11 (41%) control group: on disability, 9 (36%) Employment status: not reported Past exercise history, report currently exercising, n (%): exercise group: report currently exercising, 4 (15%) control group: report currently exercising, 4 (16%) On hormone therapy: not reported
Interventions	27 participants assigned to the exercise intervention, including: PRET supervised active and passive range of motion/stretching exercises, postural exercises, and basic strengthening exercises with light weights (1 to 5 kg) and elastic resistance bands strengthening exercises tailored for each individual to provide progressive overload of the following muscle groups: rhomboids/middle trapezius; levator scapula/upper trapezius; biceps; and triceps, deltoid, and pectoralis major, consisting of 2 sets of 10 to 15 repetitions of 5 to 8 exercise Type exercise (aerobic/anaerobic): aerobic and anaerobic Intensity of experimental exercise intervention: PRET = starting at 25% to 30% of their 1‐RM strength and slowly progressing to 60% to 70% of their 1‐RM strength by the end of the intervention period Frequency: minimum of 2 supervised sessions per week (with the option of a third session at the center or at home) for the 12‐week intervention period  Duration of session: not reported Duration of program: 12 weeks Total number of exercise sessions: 24 to 36 sessions Format: unclear Facility: facility twice a week and home or facility once per week Professionally led: physical therapist with experience working with HNC survivors provided intervention for both groups 25 participants assigned to the control group, including: supervised active and passive ROM/stretching exercises, postural exercises, and basic strengthening exercises with light weights (1 to 5 kg) and elastic resistance bands. Strengthening exercises focused on the following muscle groups: rhomboids/middle trapezius; levator scapula/upper trapezius; biceps; and triceps, deltoid, and pectoralis major Adherence: follow‐up assessment for the primary outcome was 92% exercise group: 95% control group: 87% Contamination of control group: unclear whether the control group engaged in any exercise
Outcomes	Primary outcome: patient‐rated shoulder pain and disability change in patient‐rated shoulder pain, assessed using the SPADI, based on a score from 0 to 100 with higher scores indicating more pain/disability change in shoulder disability, assessed using the Neck Dissection Impairment index, which provides a measure of treatment‐specific QoL and includes 10 questions, scored from 1(a lot) to 5 (not at all). Higher scores reflecting a greater impact on QoL Secondary outcomes: QoL and fatigue outcomes, including: FACT‐G FACT‐An subscale fatigue subscale Outcomes were measured at baseline and 12 weeks (end of the intervention): exercise group: n = 27 at baseline; at 12 weeks, n = 25 for self‐reported outcomes and n = 24 for strength and range of motion. 27 participants included in analysis control group: n = 25 at baseline; at 12 weeks, n = 23 for self‐reported outcomes and n = 22 for strength and range of motion. 25 participants included in analysis Adverse events: exercise group: colon cancer, n = 1; Soft tissue injury as a result of exercise participation, n = 1; Hospitalization for acute cholecystitis, followed by stroke, n = 1 control group: recurrence of HNC, n = 2
Notes	Country: Canada Funding: Research Award from the Physiotherapy Foundation of Canada; Full Time Health; Research Studentship from the Alberta Heritage Foundation for Medical Research; Canada Research Chairs Program; Research Team Grant from the NCIC with funds from the CCS and the Sociobehavioural Cancer Research Network
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"An independent researcher generated the allocation sequence by using a computer‐generated code"
Allocation concealment (selection bias)	Low risk	"The allocation sequence and contents of the envelopes were enclosed in sequentially numbered an sealed (opaque) envelopes"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Owing to the nature of the intervention, it was not possible to blind the participants; however, it is unclear whether the outcome was influenced by a lack of masking
Blinding of outcome assessment (detection bias) All outcomes	High risk	Study personnel and outcome assessors were not masked or blinded to the study interventions
Incomplete outcome data (attrition bias) All outcomes	Low risk	There was significant attrition from the due to adverse effect. The authors conducted ITT analyses by using baseline‐observation‐carried‐forward analyses
Selective reporting (reporting bias)	Low risk	There appears to be no selective reporting of outcomes
Other bias	Low risk	The trial appears to be free of other problems that could put it at a high risk of bias