Professional Documents
Culture Documents
1136/bjsports-2016-096651
Consensus statement
national or international profiles in exercise research and prac- report, we recommend that the contents of the reported CERT be
tice and peer recommendations. An initial list of 41 items was included in online supplementary material linked to the primary
generated from a metaepidemiological study, that included 73 paper with URLs that are designed to be stable over time. The
systematic reviews of exercise interventions for chronic health intervention information may be published as a protocol or
conditions.11 Three sequential rounds of anonymous online located on websites and other electronic repositories and options
questionnaires and a Delphi workshop were used. are described in online supplementaryappendix 2. The reporting
For each item, participants indicated agreement on an of mobile and web-based interventions can be informed by the
11-point rating scale. Consensus for item inclusion or exclusion CONSORT-EHEALTH20 and the Guidelines for reporting of
was defined a priori as >70% of respondents rating an item 7 health interventions using mobile phones: mobile health
or above or 3 or below, respectively. If consensus could not be (mHealth) evidence reporting and assessment (mERA) checklist.21
reached or changes were made to the item (eg, merging, reword- Item 1: Detailed description of the type of exercise equip-
ing etc), the items were presented to participants in a subse- ment (eg, weights, exercise equipment such as machines, tread-
quent round. mill, bicycle ergometer, etc).
The final CERT (see online supplementary appendix 1) com-
prises 16 items listed under 7 sections/domains: what (materi-
als); who ( provider); how (delivery); where (location); when,
how much (dosage); tailoring (what, how); and how well (com- Text box 1: Examples
pliance/planned and actual). For consistency, we harmonised 1. “…patients to perform the exercises with a sports rubber
domains and the ordering of items with the CONSORT band to increase the relative load in the movement directions
Statement14 and the TIDieR Checklist.7 While some items are described”22
common to the CONSORT and TIDier (study setting, provider 2. “…Treadmills, cross-trainers, stationary exercise bikes, rowing
characteristics, adverse events and adherence), Delphi panellists machines, and other types of indoor exercise equipment were
indicated that these items required further clarification for exer- used”23
cise interventions. 3. “Figure 2. Photograph showing exercise set-up with the
patient seated in an armchair with forearm support, holding the
How to use this paper dumbbell (a plastic container with a specified amount of water)
We modelled this Explanation and Elaboration document after in the affected arm, and performing exercise by lifting and
those prepared for other reporting guidelines, such as the lowering the container by extension or flexion of the wrist”24
TIDieR,7 CONSORT,14 SPIRIT,15 PRISMA: Preferred
Reporting Items for Systematic Reviews and Meta-Analyses18
and STROBE: Strengthening the Reporting of Observational
Studies in Epidemiology.19 To optimise its value, we encourage Explanation
readers to use it in conjunction with the CERT document (see Readers should be able to easily identify the type of exercise
online supplementary appendix 1). We used the qualitative data equipment that is used. These details will enable correct choice
from the Delphi study participants, the Delphi panel feedback for replication and assist budget calculations. This list of materi-
from the CERT manuscript review and the expertise of the als can be regarded as comparable to the tools required to
steering committee (SCS, CED, MU, RB) to construct the follow a recipe, for example, measuring utensils, size of dish,
Explanation and Elaboration Statement. etc. The description can include, but is not limited to, the type
We present each checklist item and follow it with published and brand of exercise machines as these vary greatly, for
examples of good reporting for that item. We edited some of example, a seated leg press may be set at different angles and
these examples by removing citations or Web addresses, or by this will influence force generation); type of weights (eg, hand
spelling out abbreviations. We explain the pertinent issue, the held dumbbells, cuff weights, olympic bar); graded elastic
rationale for including the item and relevant evidence from the bands. There should also be specific instructions regarding the
literature, whenever possible. While we present the items setup of exercise equipment such as how saddle height of an
numerically from 1 to 16, authors need not address items in ergometer was individually determined or the placement of
this particular order in their reports, although it is important elastic resistance bands.
that the information for each item is explicitly stated somewhere Item 2: Detailed description of the qualifications, teaching/
within the report. The checklist contains the minimum recom- supervising expertise and/or training undertaken by the exercise
mended items for describing an exercise intervention, recognis- instructor.
ing that there may be specific differences for reporting different
types of exercise interventions (eg, aerobic vs resistance vs
balance, etc), which may require difference types of reporting
(eg, how relative intensity is assessed, exercise duration vs set Text box 2: Examples
and reps, rest intervals, etc). Authors should provide additional 1. “All training sessions were conducted in groups of 15–20
information, such as photographs, video, website links, etc, people in a yoga studio by a certified professional yoga
where they consider it necessary. instructor”25
2. “Tai Chi movements taught by 2 certified and experienced
RESULTS instructors (average experience of 20 years)”26
The CERT Explanation and Elaboration Statement 3. “…Nine physiotherapists in private practices delivered both
The complete checklist is available in online supplementary interventions. They had an average of 12 years (range 2–
appendix 1 and table 1 provides an example pro forma for apply- 30 years) of clinical experience with musculoskeletal disorders.
ing the CERT to an exercise intervention description. If an item is Three (30%) of these physiotherapists had postgraduate masters
not applicable, the reasons should be stated. Where limitations of degree–level qualifications. All of the physiotherapists attended
word count preclude reporting all items in the body of a study a 3-hour training session and were given a treatment manual”27
2. “The exercises for the Hip group consisted of dynamic 2. “Treatment included Maitland mobilizations that were
resistance strengthening and stretching exercises for the hip progressed as the condition improved, soft tissue massage,
primarily using Thera-Band (Thera-Band, The Hygenic Corporation, myofascial trigger point release, heat, and stretches. The
Akron, Ohio) elastic bands. The exercises for the Leg group patients were also instructed on the specific shoulder exercises
consisted of dynamic resistance exercises primarily using in the home exercise program and given the information
Thera-Band elastic bands for the muscles of the lower extremities booklet”29
(quadriceps, hamstrings, and calves). The exercises for each group 3. “The intervention contained…education about duration and
are described in the Supplemental Digital Content 1 (see online intensity of brisk walking and the health benefits of exercise;
supplementary appendix, http://links.lww.com/JSM/A51)”46 identification of barriers to increasing physical activity and
3. “The strength exercises were leg extension, leg curl, leg development of strategies to overcome these barriers; value and
press, calf raises, chest press, seated row, triceps extension, identification of social support while increasing physical activity;
biceps curls, and modified curl-ups. Aerobic exercise could be relapse prevention; education about healthy diet and weight
completed on a cycle ergometer, treadmill, elliptical, rowing maintenance; and 7) physical activity safety”34
ergometer, or combination”36
Explanation
Explanation
The non-exercise components should be reported in detail as
To continue with the recipe analogy, this would equate to ‘ingre-
they may influence the overall measured effect of the interven-
dients’ (the list of exercise components), ‘procedure’ (the
tion. A complete description of the intervention should include
sequence of steps to be followed) and photographs of the prep-
items such as written instructions, education materials or train-
aration stages and plated dish (the components and completed
ing manuals and where these can be located, for example, as
exercise). For exercises to be executed as expected, explicit
online supplementary files.
information is needed about, for example, starting position, that
Item 11: Describe the type and number of adverse events that
is, lying, sitting, standing; targeted muscle groups; position in
occur during exercise.
which the exercise is performed; and range of movement. This
enables the reader to replicate or decide on a substitute exercise
and obviates ambiguity or misinterpretation. Interventions that Text box 11: Examples
consist of ‘usual care’ or ‘standard of care’ require further elab- 1. “During Progressive Resistance Training (PRT), five patients
oration in the protocol, as these can vary substantially across experienced adverse effects during or after training sessions. Two
centres, healthcare environments and countries. patients had discomfort and dizziness due to hypotension;
Item 9: Detailed description of any home programme compo- regulation of their anti-hypertensive medication solved the
nent (eg, other exercises, stretching, functional tasks, etc). symptoms. In one patient, an accumulation of blood burst during
the third training session, the bandage was changed and no
Text box 9: Examples further complications were observed. One became nauseous and
1. “All patients were encouraged to supplement the hip exercises vomited after the training session; this was…due to an earlier
with aerobic training on a stationary bike and by walking”20 tumour in the brain, and led to discontinuation of the PRT. Knee
2. “Patients were asked to perform exercises at home 4 times pain in the contra-lateral leg also led to discontinuation of the
each week in addition to the supervised physiotherapy PRT in one patient. In total, two patients discontinued the
sessions”26 intervention due to adverse effects; they participated in follow up
3. “Subjects in both exercise groups were requested to follow visits and are included in the analysis”22
only the exercises assigned for their group and to not make any 2. “During the intervention period, 17/55 (31%) participants in
significant lifestyle or exercise regime changes during the time the active group reported adverse events. These comprised
of the study”46 increased short term pain during or after the treatment session
(n=3), increased short term pain with the home exercises (12),
Explanation and mild irritation to the tape used for postural taping (2).
The addition of a home programme may influence intervention In the placebo group, 5/61 (8%) reported adverse events
outcomes and may require a record and explicit description of the comprising increased short term pain during or after the
content and a measure of adherence such as self-report by the par- treatment session. During the follow-up period, adverse events
ticipant. Depending on the type of home programme, for example, were reported only by the active group (7/49, 14%) and
additional exercise or incorporation into functional tasks, this may comprised increased short term pain with the home exercises”48
alter the overall exercise dosage and intervention outcome. 3. “Over the course of the walking program (WP) intervention, a
Item 10: Describe whether there are any non-exercise compo- small proportion of the participants complained of an increase
nents (eg, training or information materials, education, cogni- in LBP (n 55), groin (n 51), or knee (n 51) pain. An additional 7
tive–behavioural therapy, massage, etc). WP participants who complained of an increase in LBP (n 55),
knee (n 51), or groin pain (n 51), despite modification of their
weekly walking volume target were withdrawn, on average after
Text box 10: Examples 4 weeks of the programme (range, 2–5 weeks). There were no
1. “Participants in the experimental group also received health reported adverse events in the exercise class (EC) or usual
coaching via telephone. The telephone coaching involved the physiotherapy (UP) groups”49
application of health coaching principles by a physiotherapist
with three years of clinical experience and three years of tertiary
level teaching experience who had received three days of Explanation
training in health coaching. A coaching protocol was developed An adverse event refers to an untoward occurrence, which may
to guide each coaching session”47 or may not be causally related to the intervention or other
6 Slade SC, et al. Br J Sports Med 2016;0:1–10. doi:10.1136/bjsports-2016-096651
Consensus statement
3. “A visual analog scale (VAS) graded from 0 to 10 was used Text box 16a: Examples
for patient-reported pain after each training session, where 0 is 1. “The physiotherapists will attend a three-hour training
‘no pain’ and 10 ‘pain as bad as it could be’. Pain up to 2 on session covering delivery of both exercise programs and receive
the scale was considered ‘safe’ (green zone), pain up to a level a detailed treatment manual describing each exercise
of 5 was considered ‘acceptable’ (yellow zone), and pain above intervention. After initiation of the trial, telephone meetings will
5 was considered ‘high risk’(red zone).”54 be held to discuss issues experienced in the clinic and solutions
will be suggested. This procedure will reinforce similar treatment
administration among therapists”26
Explanation (14 a and b) 2. “Separate training in the content and mode of delivery of
Exercise programmes may be a predetermined and standardised each intervention was provided for therapists delivering the WP
set of exercises or tailored to the individual for reasons such as (i.e. 3 hours informed by co-author PA experts CB, W van M,
comorbidities, musculoskeletal restrictions, participant prefer- and MT and delivered by the principal investigator and local
ences and abilities or as part of the progression of exercise trial team) and the EC (7 hours delivered by JKM, who
intensity or overload that is anticipated with a progressive pro- developed the Back to Fitness programme)”49
gramme. A rationale, description and guide or system of deci-
sion rules for the tailoring, as well as implementation time
points, should be provided. This will facilitate those planning to Explanation
use the programme to know exactly how to administer it. An Fidelity refers to the extent to which the exercise intervention
example might be the ‘intensity of the exercises was adapted to occurred as the investigators intended it. For various reasons,
patient’s pain level (ie, pain should not exceed 3 on a 0–10 part or all of the exercise intervention may not be delivered as
numerical rating scale)’. intended. A description should be given of who delivered the
Item 15: Describe the decision rule for determining the start- intervention and how it was delivered. Any strategies employed
ing level at which people start an exercise programme to improve or guarantee fidelity should also be reported, such as
(eg, beginner, intermediate, advanced, etc). training, standardised therapist treatment notes or direct obser-
vation by a researcher to document adherence to the protocol.
Item 16(b): Describe the extent to which the intervention was
Text box 15: Examples: delivered as planned.
1. “…the dose was 2–3 sets of 10 repetitions, with the starting
weight matched to the participant’s 10-repetition maximum
Text box 16b: Examples
weight if possible or to a weight needed to achieve a self-rating
1. “The patients in the intervention group (IG) attended a
of 5–8 of 10 on the modified Borg RPE CR-10 scale”26
median of 19 PRT sessions (IQR: 18; 20). The resistance training
2. “All exercises will be modified so that they can be performed
was initiated at a median 5 (IQR: 5; 6) days after surgery,
at three levels of difficulty: basic, intermediate, and advanced.
postponed initiation was due to readmission for blood
For novice training, it is recommended that loads correspond to
transfusion (n ¼ 1), wound oozing (n ¼ 1) and lack of energy
a repetition range of an 8–12 repetition maximum (RM). For
(n ¼ 1). Home-based exercise was self-reportedly performed
intermediate to advanced training, it is recommended that
median 5 (IQR: 4e7) days a week in the IG as prescribed and 6
individuals use a wider loading range from 1 to 12 RM in a
(range: 4e7) days a week in the control group (CG), where
periodized fashion with eventual emphasis on heavy loading (1–
7 days a week was prescribed”21
6 RM) using 3- to 5-min rest periods between sets performed at
2. “…adherence with the protocol…they successfully
a moderate contraction velocity (1–2 s CON; 1–2 s ECC)”38
completed the walking program (WP) under the supervision of
3. “The ACSM recommends that most adults engage in
their physiotherapist, who temporarily reduced their daily
moderate-intensity cardiorespiratory exercise training for
walking volume target until the pain improved. An additional 7
≥30 min/day on ≥5 days/week for a total of ≥150 min/week,
WP participants who complained of an increase in pain…were
vigorous-intensity cardiorespiratory exercise training for
withdrawn, on average after 4 weeks of the program. The
≥20 min/day on ≥3 days/week (≥75 min/week), or a
majority received usual physiotherapy (UP). … Within the UP
combination of moderate- and vigorous-intensity exercise to
group, all participants (100%, n 577) received advice (stay
achieve a total energy expenditure of ≥500–1000 MET/min/
active: 57%, n544; back care: 56%, n543; posture: 27%, n521),
week. On 2–3 days week, adults should also perform resistance
an individualized exercise approach (stretching: 55%, n 542,
exercises for each of the major muscle groups, and neuromotor
core stability: 45%, n 535; strengthening: 15%, n 512, Pilates:
exercise involving balance, agility, and coordination”55
15%, n 512), and a home exercise program”29
Explanation Explanation
It is sensible to describe decision rules for determining the level There can be many reasons why an intervention is not delivered
at which participants start an exercise programme so that they as planned and the extent to which this occurred should be
are neither underexercised or overexercised as this may influ- reported. As well as providing an explanation for the effect or
ence engagement, participation and rates of adverse events. lack of effect of an intervention, it also provides valuable infor-
Participants may present to an exercise programme as untrained, mation to inform future studies.
semitrained or highly trained. Measures may include strength
testing using the one repetition maximum (1RM),56 the Borg
Exertion Scale57 or maximum oxygen uptake (VO2 max).58 DISCUSSION
Item 16(a): Describe how adherence or fidelity to the exercise We have presented an explanation and elaboration of a 16-item
intervention is assessed/measured. exercise-reporting template that has been endorsed by an
8 Slade SC, et al. Br J Sports Med 2016;0:1–10. doi:10.1136/bjsports-2016-096651
Consensus statement
international panel of exercise experts. It appears to be general- World Association of Medical Journal Editors (WAMJE) and the
isable across all types of exercise interventions and conditions Council of Science Editors.
and complements other more generalist tools designed to
improve the reporting of details of complex interventions in
CONCLUSIONS
clinical trials. We suggest that authors use the CERT in conjunc-
The uptake of the CERT will ultimately lead to better reporting
tion with the reporting guideline that is appropriate for their
of exercise interventions in clinical trials, and enable replication
study design (eg, CONSORT for randomised controlled trials).
in clinical practice. This Explanation and Elaboration Statement
When completing CONSORT Item 5 or SPIRIT Item 11, the
provides an explanation for how to operationalise each CERT
authors should insert a notation to refer to the CERT checklist,
item using examples from published trial papers of how good
and provide a separate and completed CERT checklist for an
reporting may be constructed. The CERT can assist researchers
exercise intervention.
to design exercise interventions; guide peer reviewers and
Detailed information about exercise interventions evaluated
editors in their evaluation of manuscripts; assist funding bodies
in clinical trials is necessary for the optimal translation of evi-
to evaluate grant applications and policymakers in exercise
dence into clinical practice. The use of the template should
recommendations; and assist clinicians to read published reports
facilitate provision of explicit details about exercise interven-
and implement effective programmrs into everyday clinical prac-
tions in clinical trials as a basic standard and is likely to be an
tice. We anticipate that the CERT will be an evolving document,
important adjunct to the CONSORT,14 SPIRIT15 and TIDieR7
as have been other reporting guidelines, with a requirement for
templates. For systematic reviews, it has been recommended to
review and refinement as new evidence and critical comments
insert an ‘intervention content’ table to explicitly describe inter-
accumulate.
ventions,56 and we suggest that for a synthesis of exercise pro-
grammes, the CERT can be substituted. Contributors SCS and RB conceived the study and all authors contributed to the
We encourage healthcare journals and editorial groups, such design and content of the study. SCS drafted the manuscript and all authors
as the World Association of Medical Editors and the provided critical input. All authors have read and approved the final manuscript.
International Committee of Medical Journal Editors, to endorse Funding This research project was funded by the 2014 Arthritis Australia Philip
the routine use of the CERT to accompany manuscript submis- Benjamin Grant, number: 2014GIA03 and the J Mason and H S Williams Memorial
sion and for use by reviewers in assessing trial and systematic Foundation (the Mason Foundation), grant number: MAS2015F037. RB is funded by
an Australian National Health and Medical Research Council (NHMRC) Senior
review manuscripts submitted for publication. Journal endorse- Principal Research Fellowship.
ment of the CONSORT Statement has demonstrated a beneficial
Competing interests MU is a director and shareholder of Clinvivo a company
effect on the completeness of reporting of the trials that they providing Smartphone apps for health services research.
publish. The number of checklist items that are reported in a
Ethics approval Cabrini Institute Ethics Committee: HREC 02-07-04-14.
manuscript is improved when journals required completion as
part of the submission process.59 An evidence synthesis of sys- Provenance and peer review Not commissioned; externally peer reviewed.
tematic review methods has demonstrated that clear procedural Data sharing statement The authors agree to share unpublished data such as
details are required for the findings of clinical trials to be imple- online survey results.
mented into practice,60 and the CERT would assist the com-
pleteness of systematic reviews of exercise efficacy. REFERENCES
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