Table 1 Items for extraction and definition of terms used in this systematic review
Extractions format and definitions | |
|---|---|
Study details | |
Author | First author surname |
Year | Year published |
Title | Title of publication |
Country | Corresponding author affiliation |
Funding source | From text |
Conflict of interest declared | Reported as yes, no, other |
Clinical trial registry ID | From text |
Methods | |
Study design | RCT, cluster RCT, other |
Study aims | From text |
Years of study recruitment | Years |
Retention strategy employed | Described where relevant as remumeration or other method |
Participants | |
Age | Mean (standard deviation), median (range) |
Gender | Male, female, other/unspecified |
Race/ethnicity | Described where possible from text |
Socioeconomic status | Employment status, income, level of education, or similar |
MS type | Type of MS of participants; relapse remitting, primary progressive, secondary progressive, progressive relapsing |
Years diagnosed with MS | Mean (standard deviation), median (range) |
Disability level* | Described where possible using Expanded Disability Status Scale or Patient Determined Disease Steps. Means (std) or median (range) will be reported. Other descriptors of disability will be reported. Described where possible as mild, moderate, or severe disability. Mild disability is usually categorised as EDSS <4.5 or PDDS 0–3, moderate disability is usually categorised as EDSS 4.5–6 or PDDS 4–5, and severe disability is usually categorised as EDSS 6.5–9.5 or PDDS 7–8. |
Inclusion/exclusion criteria | From text |
Intervention | |
Frequency | Sessions/Wk |
Intensity (aerobic exercise) | Described where relevant as light, moderate, vigorous Light intensity exercise is usually between 9 and 11 on the Borg 6 to 20 RPE scale, or 1–2 on the Borg 1–10 RPE scale. Alternatively, light intensity exercise is 30–39% VO2R or HRR [60]. Vigorous intensity exercise is usually between 14 and 17 on Borg’s 6–20 RPE scale. Alternatively, vigorous intensity exercise is 60–89% VO2R or HRR [60] |
Type* | Described where possible as aerobic, resistance, flexibility, balance, neuromotor, combined, aerobic interval training, or other Aerobic exercise training is a type of exercise in which the body’s large muscles move rhythmically for sustained periods [61]. Minimal guidelines for aerobic exercise are two 30-min sessions per week [19, 30]. Resistance exercise training refers to activities where muscles work or hold against an applied force or weight to improve muscular fitness; traditional resistance training incorporates progressions and rest intervals [62, 63]. Minimal guidelines for resistance exercise are two sessions per week comprising 5–10 exercises [19, 30]. Flexibility exercise training considers activities that are designed to preserve or extend range of motion [61]. Balance training refers to activities designed to increase lower body strength and reduce the likelihood of falls [61]. Neuromotor or multicomponent exercise training combines different motor skills (e.g., balance, coordination, gait, agility, and proprioceptive training) [62, 64]; this is not combined exercise training. Combined exercise is a combination of different exercise types within an intervention (e.g., aerobic exercise and resistance exercise). Aerobic interval involves varying the exercise intensity at fixed time interval during a single exercise session [60]. |
Session time | Session min/d |
Exercise prescription | Described where possible as modality of exercise, equipment, sets and repetition, and rest periods. Detail of progression through programme will be identified. |
Meeting minimum guidelines dose* | Identified from the frequency of aerobic exercise (2/wk) and resistance exercise (2/wk) sessions, the intensity and time of aerobic exercise (moderate intensity, 30 min [19, 29]), and the intensity of resistance exercise (one to four sets of 10 to 15 repetitions at 10–15 repetitions maximum [19, 29]) |
Programme duration | Number of weeks |
Facilitator qualifications and training | Described where possible according to clinical qualification and/or studying qualification |
Mode of delivery* | Described where possible as supervised, independent, or remotely supervised Supervised programmes are in person and supervised by a researcher trained in exercise rehabilitation, an allied healthcare professional, or students trained in exercise rehabilitation on allied healthcare. We will extract data on the setting where the exercise training is supervised. Independent programmes are completed in the participant’s community or home, and a researcher or health professional does not supervise the intervention in real-time. Information may be provided via mail or asynchronously via telehealth. Participants may provide feedback on intervention adherence to the researchers/health professionals. Synchronous communication is limited between the researcher/health professional team and the participant. Remotely supervised programmes are completed in the participant’s community or home; asynchronous telecommunication to provide supervision, programming, or intended advice is an important study construct. We will extract data on the setting where the exercise training is supervised. |
Description of comparator | Control condition will be categorised. We will extract data on the instruction provided to control participants, example categories include “usual activity”, “usual activity + social programme”, “education” |
Primary outcomes of interest | Only events occurring during the intervention period will be considered |
Relapse | Relapse is an acute onset of new or worsening neurological symptoms, lasting over 24 h [65] Will be reported on using terms “relapse” or a combination of words pertaining to “increase symptoms”, “symptom exacerbation”. From text, distinction of increased symptoms indicating a relapse will be determined from the text. |
Adverse event* (Adverse effects) | An adverse event is an unfavourable outcome that occurs during or after the intervention [33]; we consider AE to have a causal relationship, or not, to the intervention. We will focus on events that occur within the intervention delivery time-period (e.g., the weeks the intervention is delivered). Will be reported on terms “adverse event”, “adverse effect”, or “injury”, “illness”, “falls”, “joint pain”, “upper respiratory tract infection”, “sprains”, “strains”, “muscle pain”, “symptom exacerbation” Described where possible as musculoskeletal, respiratory illness, fall, cardiovascular, other From text, distinction between adverse event and adverse effect will be determined from text. We will identify the presence of causal language for example “engagement in intervention led to…” or “event was unrelated to participation in the intervention” to assist in our identification of adverse effects. |
Serious adverse event* (Serious adverse effects) | A SAE is an untoward occurrence that results in death or is life-threatening, requires hospital admission, or results in significant or permanent disability that occurs during or after the intervention [34]; we consider SAEs with a causal relationship, or not, to the intervention. We will focus on events that occur within the intervention delivery time-period (e.g., the weeks the intervention is delivered). Will be reported on terms “serious adverse event”, “heart attack”, “myocardial infarction”, “stroke”, “pulmonary embolism”, “fracture”, and “dislocation” to assist in our identification of adverse effects. Described where possible as musculoskeletal, respiratory illness, fall, cardiovascular From text, distinction between serious adverse event and serious adverse effect will be determined from text. We will identify the presence of causal language for example “engagement in intervention led to…” |
Retention rates | Retention is the completion of outcome measurements following the intervention. Will be reported on number completed first post-intervention follow-up data collection/number recruited |
Intervention adherence rate | Adherence is the extent to which the participant follows the intervention corresponding with the agreed recommendations of the study [66]; we consider adherence as attendance to exercise sessions. Will be reported on number of attended exercise sessions for the intervention. From text: terms of attendance to exercise sessions for the intervention, e.g., “attendance”, “journal”, “diary”, aspects reported will include “Frequency”, “intensity”, “modality”, “duration” |
Intervention compliance rate | Compliance is the extent to which the participant exercise behaviour matches the agreed recommendations of the study [66], we consider compliance as the completion of the prescribed exercise programme. Will be reported on compliance and completion of the prescribed programme. From text: terms of completion of the exercise prescription, e.g., “completed”, “dose”, “sets”, “repetitions”, “prescription” |
Risk of bias | |
PEDro [49] | |
Inclusion criteria and source | Not scored—extracted as above |
Random allocation | Yes/no |
Concealed allocation | Yes/no |
Baseline comparability | Yes/no |
Subject blinding | Yes/no |
Therapist blinding | Yes/no |
Assessor blinding | Yes/no |
Completeness of follow-up | Yes/no |
Intention to treat analysis | Yes/no |
Between group statistical comparisons | Yes/no |
Point measures and variability | Yes/no |