NCT04681976

Brief Summary

The aim of this study is to analyse the effectiveness of a telematic dance intervention on the quality of life of older people. This project is a controlled, randomized clinical trial. 54 people (Intervention Group, n=27; Control Group, n=27) between the ages of 60-80 will participate in the study. Intervention Group participants will perform a 3-month telematic dance program based on choreographic work. The participants shall be measured 3 times, at baseline, post-intervention, and at 6-month post-intervention follow-up. Aside from the quality of life, variables of balance, risk of falling, number of falls, level of physical activity, mood, functionality, comorbidity, and quadriceps strength will also be measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

January 11, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

December 16, 2020

Last Update Submit

September 27, 2021

Conditions

Keywords

older; dance; muscle strenght; quality of life

Outcome Measures

Primary Outcomes (1)

  • Changes in quality of Life

    Changes produced by a 3-month telematic dance program related to quality of life (EuroQol 5 Dimensions - 3 levels Index, 0 to 1 point, higher values = better outcome).

    0-3 months

Secondary Outcomes (8)

  • Adherence

    0-3 months

  • Body composition

    0-3 months

  • Balance

    0-3 months

  • Fear of falling

    0-3 months

  • Level of physical activity

    0-3-6 months

  • +3 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention Group participants will perform a 3-month telematic dance program based on choreographic work, 2 times per week

Behavioral: Telematic dance program

Control group

NO INTERVENTION

Control group will follow their daily routine without added exercise

Interventions

Telematic dance program The dance program will consist of 24 sessions distributed twice a week for a total period of 3 months. Each session will include: A) Warm up: It will consist of analytical and global movements of increasing intensity and stretching exercises. It will also involve body awareness and motor control exercises. B) Choreography part: the participants must follow and learn the choreographies. Intensity ranges shall vary between low and moderate. (3-4 in Borg's Modified Scale (0-10)). C) Cool down: It will consist of global movements of decreasing intensity, stretching, breathing, and relaxing exercises.

Intervention group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 60-80.
  • Owning a device that can connect to internet to visualize videos and do videocalls, in case a session to resolve doubts is necessary.

You may not qualify if:

  • Subjects with degenerative or cognitive pathologies
  • Subjects with severe visual deficiencies.
  • Subjects with any acute pain.
  • Subjects with inability to stand.
  • Subjects with any medical contraindication to exercise (cardiovascular risk factors).
  • Subjects incapable of managing telematic devices to follow the sessions.
  • Subjects who refuse to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia - Faculty of Physiotherapy

Valencia, 46009, Spain

Location

Study Officials

  • Francisco Martínez-Arnau, PhD

    Universitat de Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, PhD

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 23, 2020

Study Start

January 11, 2021

Primary Completion

April 30, 2021

Study Completion

September 27, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations