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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02455258
Other study ID # CRIUGM
Secondary ID
Status Completed
Phase N/A
First received March 31, 2015
Last updated July 26, 2016
Start date March 2015
Est. completion date April 2016

Study information

Verified date July 2016
Source Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

The aim of this study is to empirically evaluate the impact of a Dance/Movement Therapy program adapted to older adults. Participants over 60 years old are enrolled in one of three groups: Dance/Movement Therapy, Aerobic Exercise or Waiting List (control group) for 12 weeks. The training groups occur 3 times a week for 1 hour each session. Physical condition, cognitive function, general health and lifestyle, and stress hormones are assessed at baseline, after 12 weeks and after 28 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- aged 60 years and older

- sedentary or moderately sedentary (less than 150 minutes of moderate to vigorous exercise per week)

- have not participated in another similar study in the last year

- have not been exposed to a dance or dance/movement therapy program in the past year

- are not in a wheelchair

- have not had surgery in the past year

- have not smoked in the past 5 years

- do not consume more than 2 glasses a day of alcohol

- are not in treatment for major depression

Exclusion Criteria:

- progressive neurological disorder

- unstable medical conditions (unstable cardio illness in the past 6 months, cardiac or thyroid troubles or pituitary gland illness)

- contraindication for moderate physical activity (major orthopaedic limitations)

- suspicion of cognitive problems (score of 24 or less on the Mini-Mental State Examination)

- large uncorrected perceptual limits

- treatment of hormone therapy

- uncontrolled hearing loss

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Dance/Movement Therapy (DMT)
Each DMT session follows a similar structure of Opening, Warm up, Development, Cool Down and Closure. Various themes dedicated to an aging population are addressed by the supervising dance/movement therapist through movement activities and using support material (i.e., props, music). This group is provided in a group setting of maximum 10 participants at a time and occurs 3 times per week for 1 hour each session over the course of 12 weeks.
Aerobics Exercise (AE)
The aerobics exercise program is composed of warm up exercises followed by cardiovascular training on a recumbent bicycle. The intensity is set and progressively increased using each participants' individualized maximal aerobic power obtained in the baseline VO2 evaluation. This program respects the recommendations made by the American College of Sports Medicine and their adaptations for aging populations. Each session is supervised by a kinesiologist with 2 participants at a time. The training occurs 3 times per week for 1 hour each session over the course of 12 weeks.

Locations

Country Name City State
Canada IUGM Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Z-score change on Cognitive Functioning Assessment of executive functions, processing speed and memory 0, 12 and 28 weeks No
Secondary Z-score change on Psychological Condition SF-12 0, 12 and 28 weeks No
Secondary Z-score change on Psychological Condition Lubbens Social Network Scale 0, 12 and 28 weeks No
Secondary Z-score change on Psychological Condition Mental Health Continuum 0, 12 and 28 weeks No
Secondary Z-score change on Psychological Condition Health Promoting Lifestyle Profile 0, 12 and 28 weeks No
Secondary Z-score change on Psychological Condition State-Trait Anxiety Inventory 0, 12 and 28 weeks No
Secondary Z-score change on Psychological Condition Depression Scale 0, 12 and 28 weeks No
Secondary Z-score change on Dietary Screener Questionnaire 0,12 and 28 weeks No
Secondary Z-score change on Pittsburgh Sleep Quality Index (PSQI) 0,12 and 28 weeks No
Secondary Z-score change on Brief Pain Inventory 0, 12 and 28 weeks No
Secondary Z-score change on International Consultation on Incontinence Questionnaire-Urinary Incontinence ( ICIQ-UI) Urinary Incontinence 0, 12 and 28 weeks No
Secondary Z-score change on Physical Functioning Timed up and go 0,12 and 28 weeks No
Secondary Z-score change on Physical Functioning 10m walk 0,12 and 28 weeks No
Secondary Z-score change on Physical Functioning Grip strength 0,12 and 28 weeks No
Secondary Z-score change on Physical Condition VO2 peak 0, 12 and 28 weeks Yes
Secondary Z-score change on Physical Condition Bone density scanning (DEXA) 0, 12 and 28 weeks No
Secondary Z-score change on Physical Condition BMI 0, 12 and 28 weeks No
Secondary Z-score change on Physical Condition Rockport walking aerobic fitness test 0, 12 and 28 weeks No
Secondary Z-score change on Physical Condition Anthropometric measures composite 0,12 and 28 weeks No
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