NCT04536779

Brief Summary

The purpose of the trial is to investigate the physiological, mental, social health effect among individuals with low physical mobility participating in one of the two pre-existing initiatives: the Danish 'Team Twin' and Cycling Without Age. In these, the individuals with low physical mobility are moved by and together with by normal functioning volunteers. Based on the above, this research project will answer the following research questions:

  1. 1.Does movement by others improves the quality of life (QOL) among individuals with low physical mobility
  2. 2.Does movement by others improves the physiological health among individuals with low physical mobility
  3. 3.Does moving individuals with low physical mobility improve health among normal functioning individuals (i.e volunteer runners and pilots)?
  4. 4.How does participation in the physical activity initiatives influence well-being, relations and attitudes among relatives (to the disabled individuals) and employees at nursing homes?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

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

First Submitted

Initial submission to the registry

August 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

August 28, 2020

Last Update Submit

April 12, 2023

Conditions

Keywords

non-elite sports communityphysically challengedindividuals with low physical mobilityvolunteersrelativesdisabledQOL

Outcome Measures

Primary Outcomes (1)

  • Quality Of Life (QOL)

    Validated self-reported measure of quality of life (i.e. Cantril Ladder)

    Baseline to follow-up

Secondary Outcomes (4)

  • Physiological Health

    Baseline to follow-up

  • Mental Health

    Baseline to follow-up

  • Social Health

    Baseline to follow-up

  • Autonomy

    Baseline to follow-up

Study Arms (1)

Individuals with low mobility (Disabled and Elder)

EXPERIMENTAL

minimum 8-10 training sessions in at least three months.

Other: Training in the local departments of TT and cycling trips with CUA

Interventions

in a minimum of 3 months, the individuals with low physical mobility will conduct a minimum of 8-10 training and cycling sessions.

Individuals with low mobility (Disabled and Elder)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Disabled from the departments of TT:
  • \- Pass the medical examination conducted by the responsible investigator at the laboratory.
  • Volunteers;
  • Active member of a local department of TT
  • Volunteer in Cycling without Age
  • Relatives and nursing home employees;
  • Relative to the enrolled disabled participant
  • working at a nursing home who offers CUA

You may not qualify if:

  • \- Sustain damage, which makes the person unable to continue the training sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National institute of Public Health

Copenhagen, 1455, Denmark

Location

Related Publications (2)

  • Jorgensen A, Petersen CB, Eghoj M, Toftager M. When Movement Moves: Study Protocol for a Multi-Method Pre/Post Evaluation Study of Two Programmes; the Danish Team Twin and Cycling Without Age. Int J Environ Res Public Health. 2021 Sep 23;18(19):10008. doi: 10.3390/ijerph181910008.

    PMID: 34639309BACKGROUND
  • Jorgensen A, Toftager M, Eghoj M, Ried-Larsen M, Bjork Petersen C. Heart rate responses, agreement and accuracy among persons with severe disabilities participating in the indirect movement program: Team Twin-an observational study. Front Sports Act Living. 2023 Oct 24;5:1213655. doi: 10.3389/fspor.2023.1213655. eCollection 2023.

Related Links

Study Officials

  • Christina B Petersen, Assoc. Prof

    National Institute of Public Health, SDU

    PRINCIPAL INVESTIGATOR
  • Mette Toftager, Researcher

    National Institute of Public Health, SDU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: We will use a study design with pre- and post-measurements. The participant will be their own case-control. For optimizing the statistical strength, the individuals with low mobility will undergo two times of baseline measurements. After a minimum of a three-month trial period followup measurements will be conducted.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 3, 2020

Study Start

February 1, 2021

Primary Completion

December 1, 2021

Study Completion

February 1, 2022

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations