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Table 2 Systematic review – exercise interventions (Methodological issues/Risk of bias)

From: Exercise therapy in adults with serious mental illness: a systematic review and meta-analysis

Study

Country

Participants & setting

Design

Recruitment

Baseline sample

Number completing trial

Methodological issues/Risk of bias

Beebe et al. [41]

USA

Patients attending outpatient clinic at a Veterans Hospital

RCT

Volunteers

12

10

Participants – eligibility criteria specified - yes

- standardised diagnostic criteria - Yes

- non-random recruitment

- similar baseline groups

Intervention – details of therapists training not indicated

- no treatment manual

- compliance of medication non- checked

Measurement of Outcome

- outcome assessors blinded to treatment allocation

- adequate follow- up period

Risk of Bias - adequate sequence generation- unclear

allocation concealment- unclear

blinding of participants, personnel and outcome assessors - yes

incomplete data outcome - yes

free of selective outcome reporting- yes

free of other sources of bias- yes

Small sample, majority male, control group awareness of exercise programme.

Attendance at sessions variable.

Skrinar et al. [45]

USA

Patients from inpatient, partial hospitalisation, outpatient and community centres in area of McLean Hospital.

RCT

Selection/ invitation

30

20

Participants – eligibility criteria specified - yes

- standardised diagnostic criteria -yes

- non-random recruitment

- similar baseline groups –

Intervention – details of therapists training not indicated

- no treatment manual

Measurement of Outcome

- outcome assessors not blinded to treatment allocation

- adequate follow- up period

Risk of Bias - adequate sequence generation - unclear

allocation concealment - unclear

blinding of participants, personnel and outcome assessors - no

incomplete data outcome - no

free of selective outcome reporting - yes

free of other sources of bias - yes

Small sample, variable adherence to programme and attendance, inclusion criteria include mood disorders as well.

Control group may be affected by exercise “influence” of study.

Acil et al. [47]

Turkey

Inpatient and outpatient. Diagnosis of schizophrenia

RCT

Recruitment method not described, 30 outpatients and inpatients.

30

30

Participants – eligibility criteria poorly specified

- standardised diagnostic criteria- yes

- non-random recruitment

- similar baseline group

Intervention – details of therapists training not indicated

- no treatment manual

Measurement of Outcome

- outcome assessors not blinded

- adequate follow- up period

Risk of Bias - adequate sequence generation - no

allocation concealment - no

blinding of participants, personnel and outcome assessors - no

incomplete data outcome - unclear

free of selective outcome reporting - unclear

free of other sources of bias - yes

Non-standardized exercise intervention. No measurement of existing exercise level or patient participation in the programme.

Number completed trial not given.

Marzolini et al. [46]

Canada

Identified from Community Mental Health Programme. Majority lived supported accommodation.

RCT

Volunteers

13

13

Participants – eligibility criteria specified - yes

- standardised diagnostic criteria -yes

- non-random recruitment

- similar baseline groups –

Intervention – details of therapists training not indicated

- no treatment manual

Measurement of Outcome

- outcome assessors not blinded to treatment allocation

- adequate follow- up period

Risk of Bias - adequate sequence generation - yes

allocation concealment - yes

blinding of participants, personnel and outcome assessors - unclear

incomplete data outcome - no

free of selective outcome reporting - yes

free of other sources of bias - yes

Small sample, participants supported accommodation. Inclusion criteria – patients had to have one or more cardiovascular risk factors.

Beebe et al. [43]

USA

Outpatients

RCT

Volunteers

97

79

Participants – eligibility criteria specified

- standardised diagnostic criteria

- non-random recruitment

- similar baseline groups

Intervention – details of therapists training indicated

- treatment manual - yes

- compliance of medication non- not checked

Measurement of Outcome

- outcome assessors not blinded to treatment allocation

- adequate follow- up period

Risk of Bias - adequate sequence generation - yes

allocation concealment - unclear

blinding of participants, personnel and outcome assessors - unclear

incomplete data outcome - unclear

free of selective outcome reporting - yes

free of other sources of bias - yes

Well-designed programme. Adequate sample size.

No assessment of mental health changes - improvement in mental health may have contributed to increase in exercise by itself.

Methapatara et al. [44]

Thailand

Inpatient & Outpatients

RCT

Volunteers

64

64

Participants – eligibility criteria specified

- standardised diagnostic criteria – not indicated

- volunteers

- dissimilar baseline groups –

younger control population

Intervention – details of therapists training not indicated

- treatment manual - no

- compliance of medication not checked

Measurement of Outcome

- outcome assessors blinded to treatment allocation

- adequate follow- up period

Risk of Bias - adequate sequence generation - yes

allocation concealment - yes

blinding of participants, personnel and outcome assessors - no

incomplete data outcome - yes

free of selective outcome reporting - yes

free of other sources of bias - yes

Small sample size, no record of daily steps recorded or measurement of change in exercise levels. Compliance with programme unknown (as no recording of pedometer). No assessment of nutritional intake which may have affected outcome. Effect on mental health unknown.

Scheewe et al. [42]

USA

Community

RCT

Volunteers

118

92

Participants – eligibility criteria specified - yes

- standardised diagnostic criteria – not indicated

- non-random recruitment

- dissimilar baseline groups

Intervention – details of therapists training indicated

- treatment manual

Measurement of Outcome

- outcome assessors not blinded to treatment allocation

- adequate follow-up period

Risk of Bias - adequate sequence generation - yes

allocation concealment - yes

blinding of participants, personnel and outcome assessors - no

incomplete data outcome - unclear

free of selective outcome reporting - yes

free of other sources of bias - yes

Well-designed programme. Large sample size. Computer generated randomisation. Study part of larger research trials. No results from mental health assessment. Baseline group differences. Mean weight greater in patients than controls. Motivated group of patients with higher level of fitness at baseline. No follow up of participants to show whether improvement in exercise maintained.

Pelham et al. [48]

USA

Community Rehabilitat-ion

RCT

Volunteers

10

10

Participants – eligibility criteria specified - yes

- standardised diagnostic criteria – not indicated

- non-random recruitment

- baseline groups unclear

Intervention – details of therapists training indicated - no

- treatment manual- no

Measurement of Outcome

- outcome assessors not blinded to treatment allocation

- adequate follow-up period

Risk of Bias - adequate sequence generation - unclear

allocation concealment - unclear

blinding of participants, personnel and outcome assessors - no

incomplete data outcome - unclear

free of selective outcome reporting - unclear

free of other sources of bias – unclear

Small study. Control also using exercise activity. Data not available to include in meta-analysis. Early study 21 years ago. Beneficial effects on exercise fitness and depression scores.