NCT03898492

Brief Summary

The aim of the study was to evaluate the effect of a 8 week training period compared with control group in physical and mentally disabled adults. The effect was evaluated in relation to their physical status. Furthermore, physical activity was measured using steps and active minutes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 3, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

5 months

First QC Date

March 26, 2019

Last Update Submit

April 1, 2019

Conditions

Outcome Measures

Primary Outcomes (6)

  • Body mass index

    weight (kg)/height (m) x height (m)

    Through study completion, an average of 8 weeks

  • Blood pressure

    Diastolic pressure (mmHg) Systolic pressure (mmHg)

    Through study completion, an average of 8 weeks

  • Completed chair stands

    Number of completed chair stands

    Through study completion, an average of 8 weeks

  • Aastrand test

    Bike test to measure the physical fitness.

    Through study completion, an average of 8 weeks

  • Waist circumference

    Measured in cm

    Through study completion, an average of 8 weeks

  • Physical activity

    Number of steps and active minutes

    During test session - 2-3 days

Study Arms (2)

Intervention

OTHER

The participants in this group participated in exercise two times/week for 8 weeks

Other: Physical training

Control

NO INTERVENTION

The participants in the control group were instructed to maintain their daily routines.

Interventions

Training two times/week for an hour each time in 8 weeks. The training included strength training, aerobic training, balance training and flexibility training. The training was modified to the participants and initiated by the staff at the center.

Intervention

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • User of the centers included in the study
  • Being able to stand alone
  • Being able to use an exercise bike
  • Being able to understand danish

You may not qualify if:

  • Pregnancy
  • Pacemaker
  • Not being able to stand up by themselves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physiotherapy, University College of Northern Jutland

Aalborg, 9220, Denmark

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dorte Drachmann, Msc

    University College of Northern Jutland, Denmark. Department of Physiotherapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: One intervention group and one control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2019

First Posted

April 2, 2019

Study Start

January 3, 2018

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

April 2, 2019

Record last verified: 2019-03

Locations