Randomised Controlled Feasibility Study to Examine the Efficacy of a Combined Group-based Exercise and Educational Programme on Alcohol Consumption, Mental Health and Physical Health Among Alcohol-Dependent Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change in absolute total weekly alcohol consumption from baseline, at 24 weeks follow-up
研究概览
简要总结
This study is composed of two phases. Phase 1 will determine baseline demographic characteristics of participants, currently drinking harmful amounts of alcohol, who would be interested in an alternative treatment option to reduce alcohol consumption. Once baseline data is collected, participants will then be informed that the intervention is an exercise programme and those interested will be offered participation in Phase 2: a two-arm randomised controlled study. If eligible, participants will be randomly assigned to either: 1) a 12 week combined exercise programme and NHS standard care group, or 2) 12 weeks of NHS (National Health Service) standard care only group.
The aims are to study the feasibility of conducting a randomised controlled trial in this cohort and to determine the effectiveness of the exercise programme to reduce alcohol consumption, improve physical and mental health among people drinking harmful amounts of alcohol, compared to standard NHS care. Assessment visits, measuring alcohol consumption, mental health and physical health, will be conducted at baseline, and at Weeks 13, 24, 36 and 48 since commencement of the intervention period. Focus groups will take place during the 2nd and 12th week of the exercise programme where qualitative feedback on the exercise programme will be collected.
详细描述
Alcohol-dependent patients often experience depression, anxiety and stress, and it is thought that these may be important factors associated with increased alcohol consumption. Regular moderate/high-intensity exercise has been repeatedly reported to reduce depression, anxiety and stress, with regular exercise also shown to be effective in achieving a pleasurable state, improving coping mechanisms and increasing self-confidence among substance-dependent patients. Additionally, exercise-based therapy may be perceived by alcohol-dependent patients as a less stigmatising therapy option than traditional medication and counselling treatments.
While a small number of studies suggest that regular exercise is effective in improving fitness levels among alcohol-dependent adults, there is a lack of consensus regarding the efficacy of regular exercise to reduce alcohol consumption. Of a recent systematic review, 3 of the 5 studies reported that regular exercise reduced alcohol consumption and craving of alcohol. However, while a recent meta-analysis didn't find evidence of exercise significantly reducing alcohol consumption, the three small studies that were assessed all found that exercise training induced some reductions in alcohol consumption; suggesting that regular exercise may be effective in reducing alcohol consumption.
This study is composed of two phases. Phase 1 will determine the characteristics of participants currently drinking harmful amounts of alcohol who would be interested in being offered a new, alternative treatment to reduce alcohol consumption. During their NHS standard care (Phase 1; Visit 1), potential participants will be asked by either a member of the study team, or by the standard care team, if they "would you be willing to consider taking part in a study to look at new ways of treating people addicted to alcohol?'. While no specific details of the intervention will be provided at this time, participants who are interested will be given the participant information sheet (Phase 1) which will include further details of the study. A member of the study team will contact potential participants and, if they are happy to take part, another visit (Phase 1; Visit 2) will be arranged for patients to complete the demographic questionnaires. Visit 2 will take place at one of the study sites and written informed consent will be taken before the patient completes the study questionnaires which will determine characteristics including age, gender, ethnicity, marital status, educational background, employment status, smoking status, number of previous attempts to reduce alcohol consumption, family history of addiction, other drug intake, alcohol consumption (7 Day Drinking Diary), dependence of alcohol consumption (Alcohol Use Disorders Identification Test (AUDIT) questionnaire), severity of alcohol dependence (SADQ), alcohol craving (Penn Alcohol Craving Scale), impact of alcohol consumption on daily life (Alcohol Problems Questionnaire), depression (Patient Health Questionnaire (PHQ-9)), anxiety (Generalised Anxiety Disorder (GAD-7) questionnaire) and current physical activity levels (short-form International Physical Activity Questionnaire (IPAQ)).
Participants who complete Phase 1 of the study will be invited to participate in Phase 2 of the study on the same day (i.e. at the end of Visit 2 of Phase 1 of the study). Interested participants will be provided with full information regarding the nature of the randomised controlled trial - i.e. that this is an exercise-based intervention study - and will be given a separate participant information sheet (Phase 2). A member of the study team will contact potential participants and, if they are happy to participate, the screening visit will be arranged. Participants who decline enrolment into the exercise-based randomized controlled trial will be asked if they are willing to take part in a short telephone interview to enquire about reasons for not wanting to partake in the study. Both participants who agree, and do not agree, to take part in the short telephone interview will be offered NHS standard care. The telephone interviews will be audio-recorded, with participants consent, and transcribed verbatim. This will allow us to identify the characteristics of participants who are interested in exercise. Baseline demographics and characteristics of participants offered the intervention, who consent to provision of data, will be recorded and compared to the demographics of those who decline to participate in the intervention.
Participants who agree to participate in Phase 2 of the study will undergo screening for eligibility. Written informed consent for Phase 2 of the study will be undertaken with a 2nd informed consent form. This visit will be conducted by a member of the study team at one of the NHS hospital sites and current medications and medical history will be recorded, as well as the Physical Activity Readiness Questionnaire (PARQ), to provide a screening measure of physical readiness for exercise. Only if the participant meets the inclusion/exclusion criteria will they be allowed to continue into the study. Participants who do not meet the inclusion/exclusion criteria will be informed that they are not eligible and will be offered NHS standard care. At the end of the screening visit, an accelerometer (Actigraph) will be provided to participants who will be asked to wear it for seven consecutive days in order to measure baseline physical activity levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 65 years old
- •AUDIT score of ≥ 8
- •In the opinion of the referring physician, is capable of performing moderate/high-intensity exercise
- •Agrees to their GP being informed of their participation
- •Able and willing to provide written informed consent and complete the study questionnaires
排除标准
- •Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine.
- •Have anorexia, bipolar disorder or severe (unstable) psychosis disorder which may preclude active participation.
- •In the opinion of the referring physician, is physically incapable or likely to be incapable of undertaking an exercise programme.
- •Pregnant or planning pregnancy within the first 3 months after randomisation.
- •Currently participating in >90 minutes/week of structured moderate-intensity exercise, such as jogging, cycling or swimming (not including walking).
研究组 & 干预措施
Exercise Programme and NHS Standard Care
Exercise and NHS standard care.
干预措施: Exercise Programme (Other)
Exercise Programme and NHS Standard Care
Exercise and NHS standard care.
干预措施: NHS Standard Care (Behavioral)
NHS Standard Care only
Alcohol addiction counselling.
干预措施: NHS Standard Care (Behavioral)
结局指标
主要结局
Change in absolute total weekly alcohol consumption from baseline, at 24 weeks follow-up
时间窗: Baseline visit and Week 24 follow-up visit
The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)
Change in absolute total weekly alcohol consumption from baseline, at 36 weeks follow-up
时间窗: Baseline visit and Week 36 follow-up visit
The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)
Change in absolute total weekly alcohol consumption from baseline, at 13 weeks follow-up
时间窗: Baseline visit and Week 13 follow-up visit
The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)
Change in absolute total weekly alcohol consumption from baseline, at 48 weeks follow-up
时间窗: Baseline visit and Week 48 follow-up visit
The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)
次要结局
- Change in number of drinking days per week from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in number of drinking days per week from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in number of drinking days per week from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in number of heavy drinking days per week from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in blood aspartate aminotransferase from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in objective total physical activity expenditure from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in waist circumference from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in number of alcohol free days per week from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in number of alcohol free days per week from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in Severity of Alcohol Dependence Questionnaire (SADQ) score from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in number of alcohol free days per week from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in Alcohol Use Disorders Identification Test (AUDIT) score from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in Alcohol Use Disorders Identification Test (AUDIT) score from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in number of drinking days per week from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in number of heavy drinking days per week from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in number of heavy drinking days per week from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in Alcohol Use Disorders Identification Test (AUDIT) score from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in Alcohol Use Disorders Identification Test (AUDIT) score from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in depression from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in number of alcohol free days per week from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in Severity of Alcohol Dependence Questionnaire (SADQ) score from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in alcohol cravings from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in abstinence self-efficacy from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in alcohol problems from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in alcohol problems from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in blood alanine aminotransferase from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in number of heavy drinking days per week from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in abstinence self-efficacy from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in alcohol problems from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in alcohol problems from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in blood gamma glutamyl transferase from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in blood alanine aminotransferase from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in blood aspartate aminotransferase from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in depression from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in Severity of Alcohol Dependence Questionnaire (SADQ) score from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in alcohol cravings from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in alcohol cravings from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in alcohol cravings from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in blood gamma glutamyl transferase from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in blood alanine aminotransferase from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in blood aspartate aminotransferase from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in anxiety from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in anxiety from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in stress from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in waist circumference from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in Severity of Alcohol Dependence Questionnaire (SADQ) score from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in abstinence self-efficacy from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in abstinence self-efficacy from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in blood phosphatidylethanol (PEth) from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in blood gamma glutamyl transferase from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in blood aspartate aminotransferase from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in depression from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in body weight from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in cardiorespiratory fitness from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in blood gamma glutamyl transferase from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in blood alanine aminotransferase from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in anxiety from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in anxiety from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in depression from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in stress from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in body weight from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in cardiorespiratory fitness from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in resting systolic and diastolic blood pressure from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in stress from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in body weight from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in cardiorespiratory fitness from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in cardiorespiratory fitness from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in waist circumference from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in objective moderate-intensity physical activity levels from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in objective very high-intensity physical activity levels from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in objective low-intensity physical activity levels from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in objective high-intensity physical activity levels from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in subjective physical activity levels from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in Quality of Life score from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in stress from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in body weight from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in resting systolic and diastolic blood pressure from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in resting systolic and diastolic blood pressure from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in resting heart rate from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in resting heart rate from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in objective very high-intensity physical activity levels from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in subjective physical activity levels from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in Quality of Life score from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in waist circumference from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in resting systolic and diastolic blood pressure from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in resting heart rate from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in resting heart rate from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in objective low-intensity physical activity levels from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in objective sedentary time from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in subjective physical activity levels from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in Quality of Life score from baseline, at 36 weeks follow-up(Baseline visit and Week 36 follow-up visit)
- Change in objective high-intensity physical activity levels from baseline, at 13 weeks follow-up(Baseline visit and Week 13 follow-up visit)
- Change in objective moderate-intensity physical activity levels from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in objective total physical activity expenditure from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)
- Change in subjective physical activity levels from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in Quality of Life score from baseline, at 24 weeks follow-up(Baseline visit and Week 24 follow-up visit)
- Change in objective sedentary time from baseline, at 48 weeks follow-up(Baseline visit and Week 48 follow-up visit)