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. 2014 Apr 21;14:117. doi: 10.1186/1471-244X-14-117

Table 2.

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

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.