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Study flow diagram
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Figure 1

Study flow diagram

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Risk of bias summary: review authors' judgements about each risk of bias domain for each included study.
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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias domain for each included study.

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Comparison 1 Modafinil versus placebo, Outcome 1 Efficacy outcomes (all at 4 weeks).
Figuras y tablas -
Analysis 1.1

Comparison 1 Modafinil versus placebo, Outcome 1 Efficacy outcomes (all at 4 weeks).

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Comparison 2 Resistance exercise versus usual care, Outcome 1 Fatigue (at 6 months).
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Analysis 2.1

Comparison 2 Resistance exercise versus usual care, Outcome 1 Fatigue (at 6 months).

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Comparison 2 Resistance exercise versus usual care, Outcome 2 Functional status (at 6 months).
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Analysis 2.2

Comparison 2 Resistance exercise versus usual care, Outcome 2 Functional status (at 6 months).

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Comparison 2 Resistance exercise versus usual care, Outcome 3 Quality of life (at 6 months).
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Analysis 2.3

Comparison 2 Resistance exercise versus usual care, Outcome 3 Quality of life (at 6 months).

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Study

Respiratory exercise N

Sham intervention N

MD, 95% CI

Fatigue (FSS)

Pinto 2012

12

12

‐9.654, 95% CI ‐22.037 to 2.729

Sleepiness

Pinto 2012

12

12

0.308, 95% CI ‐3.48 to 4.096

Depression

Pinto 2012

12

12

1.769, 95% CI 0.018 to 3.52

Quality of life

Pinto 2012

12

12

0.769, 95% CI ‐17.093 to 18.631

Functional status

Pinto 2012

12

12

0.846, 95% CI ‐2.157 to 3.849

Functional status (ALSFRS‐bulbar)

Pinto 2012

12

12

‐0.385, 95% CI ‐1.378, to 0.609

Functional status (ALSFRS‐respiratory)

Pinto 2012

12

12

0.077, 95% CI ‐0.254 to 0.407

Figuras y tablas -
Analysis 3.1

Comparison 3 Respiratory exercise versus sham intervention, Outcome 1 Efficacy outcomes (all at 4 months).

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Study

Number of participants

Analysis of variance (time x treatment arm

Fatigue (FSS)

Zanette 2008

10 (5 rTMS, 5 sham intervention)

F[2,16] = 4.0; P = 0.04

Functional status

Zanette 2008

10 (5 rTMS, 5 sham intervention)

F[2,16] = 2.7; P > 0.05

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Analysis 4.1

Comparison 4 Repetitive transcranial magnetic stimulation (rTMS) versus sham intervention, Outcome 1 Efficacy outcomes (all at 2 weeks).

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Summary of findings for the main comparison. Modafinil compared to placebo in ALS/MND

Modafinil compared to placebo in ALS/MND

Patient or population: people with ALS/MND
Setting: Eleanor and Lou Gehrig MND/ALS Research Centre
Intervention: modafinil
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with placebo

Risk with modafinil

Fatigue assessed with:

Fatigue Severity Scale (FSS)
Scale from: 9 to 63 (higher indicates more fatigue)
follow up: 4 weeks

The mean FSS score was 43

MD 11 lower
(23.08 lower to 1.08 higher)

‐

32
(1 RCT)

⊕⊝⊝⊝
Very low1

Adverse events

Three adverse events led to discontinuation of modafinil (2 headache, 1 chest tightness). Anxiety (in 2 people), nausea (in 2), dizziness (in 1), and sialorrhoea (in 1; probably ALS‐related) also occurred with modafinil. Placebo group adverse events were not reported ‐ it is not clear whether there were none.

‐

32
(1 RCT)

⊕⊝⊝⊝
Very low2

The trial reported the number of adverse events in the treatment group, but not numbers of events in the placebo group or number of people experiencing adverse events

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MD: mean difference; RCT: randomised controlled trial

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1We downgraded the quality of evidence 3 times: once for study limitations and twice for imprecision. The security of blinding in the trial was unclear and the report did not provide enough information to assess attrition and selective reporting. The trial was small and the CI of the effect estimate included appreciable benefit and little or no effect.
2We downgraded the quality of evidence 3 times: once for study limitations, twice for imprecision. Reporting of adverse events was incomplete and security of blinding unclear. The trial was small and the event rate low.

Figuras y tablas -
Summary of findings for the main comparison. Modafinil compared to placebo in ALS/MND
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Summary of findings 2. Exercise compared to usual care in ALS/MND

Exercise compared to usual care in ALS/MND

Patient or population: people with ALS/MND
Setting: physical therapy service
Intervention: exercise
Comparison: usual care

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with usual care

Risk with exercise

Fatigue
assessed with:

Fatigue Severity Scale (FSS)
Scale from: 9 to 63 (higher indicates more fatigue)
follow up: 6 months

The mean FSS score was 42.7

MD 0.2 higher
(10.98 lower to 11.38 higher)

‐

18
(1 RCT)

⊕⊝⊝⊝
Very low1

‐

Adverse events

No adverse events were reported

‐

18
(1 RCT)

⊕⊝⊝⊝
Very low1

None of the people who discontinued did so because they thought the exercise programme was making their condition worse. No participants reported excessive soreness, cramping, or fatigue.

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MD: mean difference; RCT: randomised controlled trial

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1We downgraded the evidence 3 times to low quality: twice for imprecision as the trial was very small and CI included appreciable benefit and appreciable harm. The third downgrading was for study limitations as the nature of the intervention prevented participant blinding.

Figuras y tablas -
Summary of findings 2. Exercise compared to usual care in ALS/MND
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Summary of findings 3. Inspiratory muscle training compared to sham intervention in ALS/MND

Inspiratory muscle training compared to sham intervention in ALS/MND

Patient or population: people with ALS/MND
Setting: home‐based intervention
Intervention: inspiratory muscle training
Comparison: sham intervention

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk or value with sham intervention

Risk or value with inspiratory muscle training

Fatigue
assessed with:

Fatigue Severity Scale (FSS)
Scale from: 9 to 63 (higher indicates more fatigue)

follow up: 4 months

An illustrative mean FSS score in the absence of inspiratory muscle training is 42.71

MD 9.654 lower
(22.04 lower to 2.73 higher)

‐

24
(1 RCT)

⊕⊝⊝⊝
Very low2

Adverse events

The trialists stated that the exercise protocol had no adverse effects.

‐

24
(1 RCT)

⊕⊝⊝⊝
Very low2

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MD: mean difference; RCT: randomised controlled trial

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1The mean FSS score in the control group after 4 months was not available from Pinto 2012. The value given here, for illustrative purposes, is the control group mean at 6 months from Dal Bello Haas 2007.

2We downgraded the quality of evidence 3 times to very low: twice for imprecision and once for study limitations. The trial was very small and CI included appreciable benefit and little or no effect. The nature of the intervention meant that the trainer was aware of the intervention group.

Figuras y tablas -
Summary of findings 3. Inspiratory muscle training compared to sham intervention in ALS/MND
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Summary of findings 4. Repetitive transcranial magnetic stimulation (rTMS) compared to sham intervention in ALS/MND

Repetitive transcranial magnetic stimulation (rTMS) compared to sham intervention in ALS/MND

Patient or population: people with ALS/MND
Setting: secondary care
Intervention: repetitive transcranial magnetic stimulation (rTMS)
Comparison: sham intervention

Outcomes

Impact

Number of participants
(studies)

Quality of the evidence
(GRADE)

Fatigue

assessed with:

Fatigue Severity Scale (FSS)

follow‐up: 2 weeks

No FSS scores were given. The investigators assessed fatigue with the FSS using 2‐way analysis of variance (within‐subjects factor time, between‐subjects treatment arm). The trial reported a significant effect for fatigue at the end of the follow‐up period. The effect was non‐significant following post hoc Bonferroni adjustments (data not reported).

10
(1 RCT)

⊕⊝⊝⊝
Very low1

Adverse events

No adverse events were reported.

10
(1 RCT)

⊕⊝⊝⊝
Very low1

RCT: randomised controlled trial

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1We downgraded the quality of evidence 3 times: once for study limitations and twice for imprecision. The risk of bias was unclear as the trial report provided too little detail for assessment. The trial involved 10 people.

Figuras y tablas -
Summary of findings 4. Repetitive transcranial magnetic stimulation (rTMS) compared to sham intervention in ALS/MND
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Comparison 1. Modafinil versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Efficacy outcomes (all at 4 weeks) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.1 Fatigue (FSS)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Sleepiness

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Depression

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 1. Modafinil versus placebo
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Comparison 2. Resistance exercise versus usual care

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Fatigue (at 6 months) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.1 Fatigue (FSS)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Functional status (at 6 months) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 Functional status (ALSFRS total score)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Functional status (ALFRS lower extremity)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Quality of life (at 6 months) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3.1 Mental health (SF‐36)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Physical function (SF‐36)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 Physical role (SF‐36)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 Pain (SF‐36)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.5 General health (SF‐36)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.6 Vitality (SF‐36)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.7 Social function (SF‐36)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.8 Emotional role (SF‐36)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 2. Resistance exercise versus usual care
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Comparison 3. Respiratory exercise versus sham intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Efficacy outcomes (all at 4 months) Show forest plot

Other data

No numeric data

1.1 Fatigue (FSS)

Other data

No numeric data

1.2 Sleepiness

Other data

No numeric data

1.3 Depression

Other data

No numeric data

1.4 Quality of life

Other data

No numeric data

1.5 Functional status

Other data

No numeric data

1.6 Functional status (ALSFRS‐bulbar)

Other data

No numeric data

1.7 Functional status (ALSFRS‐respiratory)

Other data

No numeric data
Figuras y tablas -
Comparison 3. Respiratory exercise versus sham intervention
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Comparison 4. Repetitive transcranial magnetic stimulation (rTMS) versus sham intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Efficacy outcomes (all at 2 weeks) Show forest plot

Other data

No numeric data

1.1 Fatigue (FSS)

Other data

No numeric data

1.2 Functional status

Other data

No numeric data
Figuras y tablas -
Comparison 4. Repetitive transcranial magnetic stimulation (rTMS) versus sham intervention
Ir a la tabla de la revisión