EAL

H/A: Physical Activity (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To investigate the effect of two six-month exercise programs for HIV-infected individuals on self-efficacy, cardiovascular fitness, health-related quality of life and health status
It was hypothesized that participation in a supervised aerobic and resistance exercise program would improve self-efficacy, cardiovascular fitness, health-related quality of life and health status more than an unsupervised walking program would.

Inclusion Criteria:

Males with HIV
Age 18 years or older.

Exclusion Criteria:

Contraindications to exercise testing and training (American College of Sports Medicine 2000)
Significant cognitive impairment or inability to follow instructions
Already involved in a regular exercise program (defined as two or more structured exercise sessions weekly for six months or more prior to enrollment).

Description of Study Protocol:

Recruitment

Participants were recruited from The Alfred Hospital's infectious diseases outpatient clinic, inpatient admissions and local HIV specialist clinics.

Design

Randomized controlled trial.

Blinding Used

Single blind. The concealed randomization process used a random-number table and was done by an independent investigator. After baseline assessment, the treating physiotherapist accessed the allocation schedule from a centrally located, locked desk. An assessor who was blinded to group allocation collected outcome measures for each participant.

Intervention

Experimental: Supervised aerobic and resistance exercise program
Control: Unsupervised walking program.

Statistical Analysis

Statistical analysis was done using SAS version 8.2 on an intention-to-treat basis
Baseline comparisons were done using chi-square tests for equal proportion and Student T tests, and validated using Wilcoxon rank sum tests
Differences between groups were determined using Student T tests
Data are presented as mean (±standard deviation) and mean between-group difference (95% confidence intervals)
A two-sided P value of 0.05 was considered statistically significant.

Data Collection Summary:

Timing of Measurements

September 2002 through December 2004.

Dependent Variables

Self-efficacy: Measured using the General Self-Efficacy Scale a 10-item self-administered questionnaire with a four-point response scale
Cardiovascular fitness: Measured using the Kasch Pulse Recovery test
Health-related quality of life: Measured using the Medical Outcomes Study HIV Health Survey, covering 10 dimensions of health and one item covering health transition
Health status: Assessed with CD4 count, HIV viral load and weight.

Independent Variables

Experimental group
- Supervised aerobic and resistance exercise program
- Group exercises performed twice weekly either at the hospital or at an affiliated community gymnasium
- Supervised by a physiotherapist experienced in managing treatment of people with HIV
- 60-minute sessions.
Control group
- Unsupervised walking program
- Twice-weekly 20-minute walks in the community
- Participants attended a monthly forum led by a physiotherapist.

Control Variables

Baseline characteristics included information on ethnicity, employment status, relationship status, depression status, education status and smoking status.

Description of Actual Data Sample:

Initial N

40 participants (men) were recruited based on a power test and allowing for a drop-out rate of 20%.

Attrition (final N)

Experimental, 17; Control, 18
Reasons for failure to complete: returning to work (n=1), lack of motivation (n=1), depression (n=2) and unknown (n=1)
Reviewers note: n=16 was the outcome of the power test.

Age (mean±standard deviation, range)

Experimental (43.3±7.7years, 31years-61years)
Control (43.7±10years, 31years-71years).

Ethnicity

Experimental: White,100%; Indigenous/Aboriginal, 0%
Control: White: 90%; Indigenous/Aboriginal, 10%.

Other relevant demographics

Employment status

Experimental: Full/part time/casual work, 45%; studying and not working, 5%; studying and working, 5%; pension, 45%
Control: Full/part time/casual work, 45%; studying and not working, 0%; studying and working, 0%; pension, 55%.

Relationship status

Experimental: Relationship, 45%; single, 55%
Control: Relationship, 50%; single, 50%.

Depression status

Experimental: Currently depressed, 25%; past depressed, 25%; never depressed, 50%
Control: Currently depressed, 20%; past depressed, 15%; never depressed, 65%

Education status

Experimental: Primary, 10%; secondary incomplete, 35%; secondary completed, 35%; some additional training, 10%
Control: Primary, 35%; secondary incomplete, 30%; secondary completed, 15%; some additional training, 10%.

Smoking status

Experimental: Yes, 60%; no, 40%
Control: Yes, 75%; no, 25%.

Self-efficacy, cardiovascular fitness, health-related quality of life and health status were also not different between the groups.

Anthropometrics

None listed.

Disease Information at baseline

HIV (years, mean±standard deviation)

Experimental: 6.5±5.8
Control: 9.9±6.4

HIV transmission risk group

Experimental: Homosexual, 85%; heterosexual, 5%; other, 10%
Control: Homosexual, 90%; heterosexual, 0%; other, 10%

Antiretroviral use

Experimental: Yes, 60%; no, 40%
Control: Yes, 65%; no, 35%

Location

Alfred Hospital or an affiliated community gymnasium; surrounding community for walking for control group.

Summary of Results:

Table 2. Differences within groups and differences between groups for all outcome measures

Outcome	Within-group Difference Post minus Pre Mean±Standard Deviation		Between-group Difference Post minus Pre Mean (95% Confidence Interval)
Outcome	Experimental (n=17)	Control (n=18)	Experimental minus Control
Self-efficacy (10-40)	5.3±3.7	-1.5±4.5	6.8 (3.9 to 9.7) **
Cardiovascular fitness (bpm)	-19.6±11.7	0.6±2.9	-20.2 (-25.8 to -14.6)**
Health-related quality of life (0-100)
Overall health	14.0±17.4	-6.8±37.5	20.8 (2.0 to 39.7)*
Cognitive function	13.5±22.0	-0.5±19.5	14.0 (0.7 to 27.3)*
Quality of life	16.3±23.3	8.8±33.7	7.5 (-11.1 to 26.1)
Energy/fatigue	6.0±24.0	1.5±18.3	4.5 (-9.2 to 18.2)
Pain	1.1±46.6	3.3±20.1	-2.2 (-25.2 to 20.7)
Physical function	16.7±29.7	1.3±21.0	15.4 (-1.1 to 31.9)
Social function	-1.0±87.2	10.0±38.7	-11.0 (-54.2 to 32.2)
Mental health	8.2±14.1	2.4±17.8	5.8 (-4.5 to 16.1)
Role function	7.5±40.6	47.5±215	-40.0 (-139.3 to 59.3)
Health distress	6.0±24.7	4.8±18.7	1.3 (-12.8 to 15.3)
Health transition	11.3±41.7	-1.3±35.8	12.5 (-12.4 to 37.4)
Health status
CD4 count (cells/mm³) (n=34)	-31.5±148.9	4.1±191.5	-35.6 (-156.6 to 85.3)
HIV RNA viral load (copies/ml) (n=32)	-91,885±23,3151	53,135±234,598	-145 022 (-316,950 to 26,908)
Weight (kg)	2.0±3.5	-0.1±2.9	2.1 (-0.1 to 4.3)

* Significant difference between groups P<0.05.

** Significant difference between groups P<0.001.

Other Findings

High rates of adherence to the exercise programs were observed in both groups. Participants in the experimental group attended an average of 81% of the exercise sessions. Those in the control group carried out an average of 85% of the walking sessions and attended an average of 60% of the forums.

Author Conclusion:

Results indicate that a six-month supervised aerobic and resistance exercise program improves self-efficacy and cardiovascular fitness more than an unsupervised walking program in adult men with HIV.

Funding Source:

University/Hospital:

Alfred Hospital Small Projects Grant

Reviewer Comments:

Implied limitation: The supervision provided by a physiotherapist with knowledge and expertise in the management of HIV may have been a factor in enhancing self-efficacy, although this cannot be separated from the effect of the exercise program.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	Yes
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		Yes
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	Yes
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	N/A
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	Yes
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	???
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes