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OpenTrials
Completed

NCT Number: NCT01443455

Adherence and Health Effects of Video Dance in Postmenopausal Women

This is a 6 month randomized clinical trial comparing video dance, brisk walking and delayed entry controls. The interventions have two phases; a 12 week initiation phase with substantial structure and supervision, followed by a 12 week transition phase, with reduced structure and supervision. Participants are 168 overweight or obese, sedentary postmenopausal women aged 50 to 65; 60 in each exercise arm and 48 in the wait list control group.

The following research questions will be assessed:

1. Is exercise adherence at 6 months better with video dance games compared to brisk walking? 2. Does video dance game exercise compared to wait list controls, induce beneficial changes in physical and mental health? 3. Does video dance game exercise compared to brisk walking better promote balance, attention and visual spatial skills, without loss of benefit to cardiovascular fitness? 4. Is video dance preferred to brisk walking for exercise among postmenopausal women? If so, who and why?

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Key information

Conditions

Post Menopausal Behavior Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be female
  • age 50-65
  • not currently exercising at least 20 minutes
  • three times per week
  • a BMI of 25 or higher

Exclusion criteria

  • Exclusions are largely related to medical safety and include history of osteoporosis, osteoporotic fractures, active cardiovascular disease, uncontrolled hypertension, weight bearing pain that would limit exercise, seizure disorder or any medical condition or medication that would limit the safety of the study.

Treatment and study plan

videodance

Behavioral

Using a commercially available product called Dance Dance Revolution (DDR) this video-game based dancing system uses a game player, force sensing pad and software. The step sequences are set to a wide range of music and become more complex and frequent as the dancer gains skill. Participants are oriented over 2 weeks. For the rest of the first 3 months, the participant attends at least one supervised session per week. Participants may use the center for additional, unsupervised sessions and/or they can take a dance system home. They also receive brief behavioral intervention sessions for safety orientation, exercise education and adherence promotion. For the following 3 months, the participant enters the transition phase in which she is encouraged to continue to exercise but no formal supervision is provided.

Other names: Konami

Brisk walking

Behavioral

The overall goal is to increase the duration and speed of walking, using structure and supervision for the first three months, followed by reduced support in the second three months. For the first two weeks, each participant comes to the center at least twice a week to walk.They are encouraged to gradually increase effort and duration to a target of 150 minutes per week of brisk walking.Participants are taught to use Borg's ratings of perceived exertion and self-monitored heart rate to target their level of activity. The next 10 weeks include once weekly supervised sessions and additional sessions either at the center or in preferred community settings. The recommended goal is a minimum of 150 minutes per week of exercise in sessions of at least 10 -15 minutes duration.Participants are given pedometers in order to help them monitor their progress. After 12 weeks, the participant enters a transition phase for a further 3 months.

delayed entry control

Behavioral

Participants who are randomized to the delayed entry non-exercise control group receive the American Heart Association pamphlet, but no direct support for exercise implementation. After they have completed six months of follow up, they are invited to select any combination of dancing and walking that they prefer and then receive support and instruction according to the protocols described above.

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Primary outcomes

  1. Adherence

    Time frame: six months after randomization

    minutes per week of moderate or greater physical exercise activity assessed using accelerometers and activity diaries

Secondary outcomes

  1. Endurance

    Time frame: 3 and 6 months

    timed 2 km walk

  2. body composition

    Time frame: 6 months

    Lunar Prodigy DXA scanner for lean body mass and total fat mass

  3. vascular health

    Time frame: 6 months

    blood pressure, pulse, lipid levels, fasting glucose, fasting insulin and C reactive protein

  4. balance

    Time frame: 3 and 6 months

    timed one foot stand and timed narrow walk

  5. personality

    Time frame: baseline

    NEO Personality Inventory

  6. sleep quality

    Time frame: 3 and 6 monhts

    Pittsburgh Sleep Quality Index

  7. visuospatial/constructional function

    Time frame: 3 and 6 monhts

    domain of the Repeatable Battery for the Assessment of Neuropsychological Status

  8. attention domain

    Time frame: 3 and 6 monhts

    subtests of the Repeatable Battery for the Assessment of Neuropsychological Status

  9. Useful Field of View

    Time frame: 3 and 6 monhts

    Useful Field of View test

  10. step reaction time

    Time frame: 3 and 6 months

    Step Reaction Tasks

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Phase 2 Trial of Video Dance Versus Walking in Postmenopausal Sedentary Overweight Women

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 29, 2011
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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