NCT01443455

Brief Summary

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. 1.Is exercise adherence at 6 months better with video dance games compared to brisk walking?
  2. 2.Does video dance game exercise compared to wait list controls, induce beneficial changes in physical and mental health?
  3. 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. 4.Is video dance preferred to brisk walking for exercise among postmenopausal women? If so, who and why?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2012

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

2.6 years

First QC Date

September 27, 2011

Last Update Submit

September 27, 2017

Conditions

Keywords

menopausesedentaryoverweight

Outcome Measures

Primary Outcomes (1)

  • Adherence

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

    six months after randomization

Secondary Outcomes (10)

  • Endurance

    3 and 6 months

  • body composition

    6 months

  • vascular health

    6 months

  • balance

    3 and 6 months

  • personality

    baseline

  • +5 more secondary outcomes

Study Arms (3)

VideoDance

EXPERIMENTAL
Behavioral: videodance

Brisk Walking

ACTIVE COMPARATOR
Behavioral: Brisk Walking

Delayed entry control

OTHER

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.

Behavioral: delayed entry control

Interventions

videodanceBEHAVIORAL

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.

Also known as: Konami
VideoDance
Brisk WalkingBEHAVIORAL

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.

Brisk Walking

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. \--------------------------------------------------------------------------------

Delayed entry control

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Jovancevic J, Rosano C, Perera S, Erickson KI, Studenski S. A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function. BMC Geriatr. 2012 Jun 6;12:23. doi: 10.1186/1471-2318-12-23.

MeSH Terms

Conditions

Sedentary BehaviorOverweight

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stephanie A Studenski, MD MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 27, 2011

First Posted

September 29, 2011

Study Start

January 1, 2010

Primary Completion

July 31, 2012

Study Completion

September 30, 2012

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations