Music for Alzheimer's Disease Prevention (iSTEP+ Trial)
Palo Alto (17 mi)Overseen byKyoung Shin Park, PhD
Age: 65+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of North Carolina, Greensboro
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to test the benefits of beat-accented music stimulation (BMS) for behavioral changes of physical activity (PA) in older adults with subjective memory complaints. Specific Aims are to determine (1) whether BMS beneficially influences PA behaviors and psychological responses to PA in older adults for 6 months, and (2) whether exercising with BMS differently influences physical and cognitive functioning as well as quality of life in older adults.To test the effects of BMS on PA, participants will be randomly assigned to an exercise intervention that either includes BMS or does not include BMS. Participants will attend a supervised group strength training (ST) (30 min/day) and and aerobic exercise (AE) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/week for the next 2 months (while encouraging participants to independently perform both AE and ST on other days), and independently for the final 2 months (always with a goal of performing \>150min/week AE and 3 days/week of ST for 30 min/day).
What data supports the idea that Music for Alzheimer's Disease Prevention is an effective treatment?The available research shows mixed results for the effectiveness of Music for Alzheimer's Disease Prevention. One study found that listening to Mozart improved spatial-temporal reasoning in a person with Alzheimer's, suggesting music might help with certain cognitive tasks. Another study noted that music-based interventions could improve quality of life and mood, though they had limited effects on cognition. Additionally, rhythmic auditory stimulation seemed to reduce the burden on caregivers during walking exercises, even if it didn't significantly change walking characteristics. Overall, while music shows some promise, more research is needed to fully understand its benefits compared to other treatments.246911
Is Beat-accented music stimulation (BMS) a promising treatment for Alzheimer's disease prevention?Yes, Beat-accented music stimulation (BMS) is a promising treatment for Alzheimer's disease prevention. Research suggests that music can improve memory, mood, and cognitive functions in people with Alzheimer's. Music therapy can enhance quality of life, reduce medication needs, and help with mood and self-expression. It also shows potential in maintaining cognitive abilities and improving mood in dementia patients.128911
What safety data exists for music-based treatments for Alzheimer's prevention?The pilot study on Rhythmic Auditory Stimulation (RAS) with traumatic brain injury patients reported no adverse events, suggesting a favorable safety profile. However, specific safety data for music-based treatments in Alzheimer's prevention is not directly available in the provided research. Further studies are needed to confirm safety in this specific context.357810
Do I need to stop taking my current medications to join the trial?The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are using medication for Alzheimer's disease or if you've changed the dosage of medications for anxiety or depression in the last 6 months.
Eligibility Criteria
This trial is for older adults with memory complaints who are able to participate in regular physical activity. They should be willing to exercise with or without beat-accented music as part of the study and commit to a structured exercise program for 6 months.Inclusion Criteria
I am 65 years old or older.
I can walk for 6 minutes without help or pain.
I do not have thoughts of suicide and am not diagnosed with depression.
Exclusion Criteria
I have not had a stroke or brain injury in the last 6 months.
I have been diagnosed with a neurological or spinal cord disorder.
I cannot or do not want to attend the required classes 3 times a week initially, then once a week.
I have been diagnosed with clinical depression.
I have hearing or vision problems that haven't been corrected.
I have not had a hip, knee, or spinal fracture or surgery in the last 6 months.
I understand the study procedures.
Treatment Details
The trial is testing if exercising while listening to beat-accented music can improve physical activity, cognitive function, and quality of life in seniors. Participants will do strength training and aerobic exercises either with or without music.
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise and musicExperimental Treatment1 Intervention
The strength training (ST) program incorporates single-leg exercises for balance training and training with resistance bands and body weight. During the ST, participants will be asked to synchronize their concentric and eccentric muscle contractions in time with the tempo of BMS playlists at a specific music tempo. For aerobic exercise (AE), participants will be instructed to walk at moderate intensity with duration increasing up to an ultimate goal of 150 min/week. Participants will be trained to walk in synchrony with the beats. Participants will receive individualized music playlists to match individual walking cadence and music preference.
Group II: ExerciseActive Control1 Intervention
The ST program incorporates single-leg exercises for balance training and training with resistance bands and body weight. For AE, participants will be instructed to walk at moderate intensity with duration increasing up to an ultimate goal of 150 min/week.
Find a clinic near you
Research locations nearbySelect from list below to view details:
UNC GreensboroGreensboro, NC
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Who is running the clinical trial?
University of North Carolina, GreensboroLead Sponsor
Alzheimer's AssociationCollaborator
References
Alzheimer's disease: rhythm, timing and music as therapy. [2022]Active music-making provides a form of therapy for the Alzheimer's patient which may stimulate cognitive activities such that areas subject to progressive failure are maintained. Anecdotal evidence suggests that quality of life of Alzheimer's patients is significantly improved with music therapy, accompanied by the overall social benefits of acceptance and sense of belonging gained by communicating with others. Music therapy, when based on clear treatment objectives can reduce the individual prescription of tranquilizing medication, reduce the use of hypnotics and help overall goals of rehabilitation. Mood improvement and self-expression, the stimulation of speech and organisation of mental processes; and sensory stimulation and motor integration are promoted. Given that the rate of deterioration in Alzheimer's disease is not predictable, a series of single case experimental designs would generate valuable empirical data concerning treatment outcome and promote basic research into the timing functions required for the co-ordination of cognition, physiology, motor ability and the integrity of behaviour.
Enhancement of spatial-temporal reasoning after a Mozart listening condition in Alzheimer's disease: a case study. [2019]Several recent studies have investigated the effectiveness of various behavioral interventions on the cognitive performance of subjects with Alzheimer's disease (AD). Simulations of Shaw's structured model of the cortex led to the predictions that music might enhance spatial-temporal reasoning. A subsequent behavioral study in college students documented an improvement in scores on a spatial-temporal task after listening to a Mozart piano sonata. In this study, we investigated the enhancement of scores on a spatial-temporal task after a Mozart listening condition in a set of twins who are discordant for AD. After listening to an excerpt from a Mozart piano sonata, the AD twin showed considerable improvement on the spatial-temporal task when compared with pretest scores. Furthermore, no enhancement of scores was seen following either of the control conditions (i.e., silence or 1930s popular tunes). This finding suggests that music may be used as a tool to investigate functional plasticity in Alzheimer's disease and to better understand the underlying pathophysiology.
Use of binaural beat tapes for treatment of anxiety: a pilot study of tape preference and outcomes. [2007]Recent studies and anecdotal reports suggest that binaural auditory beats can affect mood, performance on vigilance tasks, and anxiety.
The effect of rhythmic auditory stimulation (RAS) on gait characteristics of cadence, velocity, and stride length in persons with late stage dementia. [2022]Persons (N = 28) diagnosed with dementia in late stage who had locomotion Functional Independence Measure (FIM) ratings of l, total assistance required, and 2, maximal assistance required, participated as subjects. All participants were enrolled in a restorative ambulation program which was implemented in this study under 3 conditions: Rhythmic auditory stimulation in which metronomic beats were imbedded in music, rhythmic auditory stimulation which consisted of metronomic beats without music, and no auditory stimulus. Gait characteristics of cadence, velocity, and stride length were compared across the 3 conditions. No statistically significant differences were found, however, observation showed that assistive burden seemed less when both forms of rhythmic auditory stimulation were used. Further research is recommended to study the effects of RAS on care burden and continued ambulation throughout the disease trajectory.
Comparison of different methods for eliciting exercise-to-music for clients with Alzheimer's disease. [2019]Many of the noted problems associated with Alzheimer's disease (AD) sometimes can be delayed, retarded, or even reversed with proper exercise and interaction with the environment. An overwhelming body of research efforts has revealed that music activity brings about the greatest degree of responsiveness, including exercise, in clients with AD; yet, specific techniques which elicit the greatest amount of physical responses during the music activities remain unidentified. The purpose of this study was two-fold: comparing two methods of intervention and comparing responses to vocal versus instrumental music during exercise and exercise with instruments. In Experiment 1 the authors compared 2 treatment conditions to facilitate exercise during music activities: (a) verbalizing the movement for each task once, one beat before commencing, followed by visual cueing for the remainder of the task; (b) verbal and visual cueing for each revolution or change in rhythm for the duration of the task. Data collection over 38 sessions consisted of recording the participation of each client at 30-second intervals for the duration of each treatment condition, indicating at each interval whether the client was participating in the designated movement (difficult), participating in exercise approximating the designated movement (easy), or not participating. Results indicated that the continuous verbal cueing/easy treatment elicited significantly greater participation than one verbal cue/difficult treatment, p
Effects of response-related music stimulation versus general music stimulation on positive participation of patients with Alzheimer's disease. [2018]Assessing the effects of response-related music stimulation versus general (response-unrelated) music stimulation on positive participation of 11 new patients with Alzheimer's disease.
Auditory beat stimulation and its effects on cognition and mood States. [2022]Auditory beat stimulation may be a promising new tool for the manipulation of cognitive processes and the modulation of mood states. Here, we aim to review the literature examining the most current applications of auditory beat stimulation and its targets. We give a brief overview of research on auditory steady-state responses and its relationship to auditory beat stimulation (ABS). We have summarized relevant studies investigating the neurophysiological changes related to ABS and how they impact upon the design of appropriate stimulation protocols. Focusing on binaural-beat stimulation, we then discuss the role of monaural- and binaural-beat frequencies in cognition and mood states, in addition to their efficacy in targeting disease symptoms. We aim to highlight important points concerning stimulation parameters and try to address why there are often contradictory findings with regard to the outcomes of ABS.
Music and Memory in Alzheimer's Disease and The Potential Underlying Mechanisms. [2022]With population aging and a projected exponential expansion of persons diagnosed with Alzheimer's disease (AD), the development of treatment and prevention programs has become a fervent area of research and discovery. A growing body of evidence suggests that music exposure can enhance memory and emotional function in persons with AD. However, there is a paucity of research that aims to identify specific underlying neural mechanisms associated with music's beneficial effects in this particular population. As such, this paper reviews existing anecdotal and empirical evidence related to the enhancing effects of music exposure on cognitive function and further provides a discussion on the potential underlying mechanisms that may explain music's beneficial effect. Specifically, this paper will outline the potential role of the dopaminergic system, the autonomic nervous system, and the default network in explaining how music may enhance memory function in persons with AD.
Resting-State Connectivity of Auditory and Reward Systems in Alzheimer's Disease and Mild Cognitive Impairment. [2020]Music-based interventions (MBI) have become increasingly widely adopted for dementia and related disorders. Previous research shows that music engages reward-related regions through functional connectivity with the auditory system, but evidence for the effectiveness of MBI is mixed in older adults with mild cognitive impairment (MCI) and Alzheimer's disease (AD). This underscores the need for a unified mechanistic understanding to motivate MBIs. The main objective of the present study is to characterize the intrinsic connectivity of the auditory and reward systems in healthy aging individuals with MCI, and those with AD. Using resting-state fMRI data from the Alzheimer's Database Neuroimaging Initiative, we tested resting-state functional connectivity within and between auditory and reward systems in older adults with MCI, AD, and age-matched healthy controls (N = 105). Seed-based correlations were assessed from regions of interest (ROIs) in the auditory network (i.e., anterior superior temporal gyrus, posterior superior temporal gyrus, Heschl's Gyrus), and the reward network (i.e., nucleus accumbens, caudate, putamen, and orbitofrontal cortex). AD individuals were lower in both within-network and between-network functional connectivity in the auditory network and reward networks compared to MCI and controls. Furthermore, graph theory analyses showed that the MCI group had higher clustering and local efficiency than both AD and control groups, whereas AD individuals had lower betweenness centrality than MCI and control groups. Together, the auditory and reward systems show preserved within- and between-network connectivity in MCI individuals relative to AD. These results motivate future music-based interventions in individuals with MCI due to the preservation of functional connectivity within and between auditory and reward networks at that initial stage of neurodegeneration.
Rhythmic Auditory Stimulation and Gait Training in Traumatic Brain Injury: A Pilot Study. [2021]Rhythmic auditory stimulation (RAS) has been well researched with stroke survivors and individuals who have Parkinson's disease, but little research exists on RAS with people who have experienced traumatic brain injury (TBI). This pilot study aimed to (1) assess the feasibility of the study design and (2) explore potential benefits. This single-arm clinical trial included 10 participants who had a 2-week control period between baseline and pretreatment. Participants had RAS daily for a 2-week treatment period and immediately completed post-treatment assessments. Participants then had a 1-week control period and completed follow-up assessment. The starting cadence was evaluated each day of the intervention period due to the variation in daily functioning in this population. All 10 participants were 1-20 years post-TBI with notable deviations in spatial-temporal aspects of gait including decreased velocity, step symmetry, and cadence. All participants had a high risk of falling as defined by achieving less than 22 on the Functional Gait Assessment (FGA). The outcome measures included the 10-m walk test, spatial and temporal gait parameters, FGA, and Physical Activity Enjoyment Scale. There were no adverse events during the study and gait parameters improved. After the intervention, half of the participants achieved a score of more than 22 on the FGA, indicating that they were no longer at high risk of experiencing falls.
Long-Term Multi-Sensory Gamma Stimulation of Dementia Patients: A Case Series Report. [2023]Dementia prevalence is increasing globally, and symptom management and treatment strategies require further investigation. Music-based interventions have demonstrated some efficacy with respect to quality of life and symptom reduction, though limited with respect to cognition. This study reports on three case studies where the use of gamma stimulation over one year contributed to maintenance of cognition and increases in mood for participants with Alzheimer's disease or mild cognitive impairment. Auditory stimulation with isochronous sound at 40 Hz was delivered to participants via a commercially available vibroacoustic chair device five times per week for 30 min with assistance from caregivers. Further research is needed to assess the integration of this therapy in the overall care for persons with dementia.