The Impact of Concurrent Training on Women Experiencing Symptoms of Menopause
ConditionMenopause Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorUniversity College Dublin
About this trial
The aim of this study is to examine the impact of a concurrent training exercise intervention on menopausal symptoms and key physical and mental health outcomes. The proposed study is powered based on a primary outcome of examining the change in menopausal symptoms using the MenQoL questionnaire. Participants (n=70) will be randomised to an intervention or control group. The intervention group will participate in a 12 week online (via zoom) concurrent training programme, consisting of three forty-five minute sessions (on non-consecutive days) per week that align with WHO exercise recommendations for adults and the control group will maintain their regular activity. The exercise classes will be delivered by qualified Sport \& Exercise Scientists and will consist of a combination of bodyweight and resistance band exercises. Each class will consist of a 5 minute warm up, 15 minutes of aerobic exercise, 20 minutes of resistance training, and a 5 minute cool-down. Both groups will engage in pre and post testing through questionnaires (GAD-7, Patient Health Questionnaire-9 (PHQ-9), Menopause-Specific Quality of Life Questionnaire (MENQOL), Body Appreciation (BAS-2)), Pittsburgh Sleep Quality Index Sleep, International physical activity questionnaire (IPAQ), Body image questionnaire (BAS-2) and physical tests (Bod pod, grip-strength, 3-RM leg press, 3-RM cable pull, counter-movement jump and Astrand Rhyming submaximal aerobic test).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women experiencing perimenopause (irregular menstrual cycles of ≥7-day difference in cycle length of consecutive menstrual cycles) and early postmenopause (< 5 years post menopause).
Able to safely engage in a concurrent training interventions that combine both aerobic and resistance training.
Must have reliable internet access and a device capable of participating in online training on zoom.
Willingness and ability to provide informed consent and comply with study procedures.
Disqualifiers
BMI >35 and <18.5.
Currently taking psychotropic medication
Has undergone a hysterectomy
Current substance abuse
Trial design
Design model
Parallel
Treatments tested in this trial
Concurrent training
BehavioralConcurrent training programme
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Menopause Symptoms (Menopause-Specific Quality of Life Questionnaire)
29 symptoms of menopause are listed. For each symptom participants are asked to indicate whether they have experienced the symptom in the past month. If they have experienced it they will be asked to rate (on a scale of 0-6) how much they have been bothered by that symptom (0=not bothered at all; 6=extremely bothered).
Time frame
Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)Secondary outcomes
1
Anxiety (GAD-7)
7 symptoms of anxiety listed. Participants are asked how often each symptom has bothered (on a scale of 0 to 3) them over the past 2 weeks (0=not at all; 1=several days; 2=more than half the days, 3=nearly everyday).
Time frame
Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)2
Depression (Patient Health Questionnaire - 9)
9 symptoms of depression listed. Participants are asked how often each symptom has bothered (on a scale of 0 to 3) them over the past 2 weeks (0=not at all; 1=several days; 2=more than half the days, 3=nearly everyday).
Time frame
Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)3
Pittsburgh Sleep Quality Index
10 questions. For each question participants are asked to answer as relates to the past month. The first 4 questions are open ended and the next 5 are answered either (not during the past month; less than once a week; once or twice a week; three or more times a week)
Time frame
Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)4
Body Appreciation Scale
13 items. Participants are asked to give one of five possible answers for each of the 13-items (1-5). A higher score indicates a greater appreciation for one's body (1=never; 2=seldom; 3=sometimes, 4=often, 5=always).
Time frame
Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)Sponsors and contacts
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Source ClinicalTrials.gov