NCT01822938

Brief Summary

Physical exercise has been identified as a major item of many affecting many chronic diseases and stroke rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side-effects and mortality. Stroke in association with an inactive lifestyle lead to a decrease in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to vicious circle of less and less mobility. Therefore, physical activity for the health is a valid and relevant way to improve the quality of life and to recover functional capacity. The aim of the study is the assessment of the effects of a incentive program for physical activity on people following/with stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable stroke

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

March 25, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 14, 2018

Status Verified

March 1, 2015

Enrollment Period

4.7 years

First QC Date

March 25, 2013

Last Update Submit

August 10, 2018

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • The distance on the 6 minute walking test (6MWT)

    6 minutes

Secondary Outcomes (1)

  • Quality of life

    at 0 month, 6 months and 12 months

Study Arms (2)

effects of a incentive program for physical activity

EXPERIMENTAL

The aim of the study is the assessment of the effects of a incentive program for physical activity on people following/with stroke

Other: incentive program for physical activity

control group

NO INTERVENTION

No intervention

Interventions

incentive program for physical activityOTHER
effects of a incentive program for physical activity

Eligibility Criteria

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

You may qualify if:

  • Person having stroke (ischemic or hemorrhagic)
  • Whatever the area of stroke
  • Person supported by HEMIPASS (monitoring team and home support)
  • Stroke less than 6 months
  • Patient walking with or without technical or human assistance: FCC score

You may not qualify if:

  • Disability limiting the gait before the stroke
  • Age \< 18 years
  • Cognitive impairment limiting participation to the program
  • Non signature of the consent
  • cardiopulmonary pathology which forbid/banned effort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Limoges

Limoges, 87 042, France

Location

Related Publications (3)

  • Guediri A, Chaparro D, Borel B, Daviet JC, Compagnat M, Mandigout S. The effect of a home-based coaching program on heart rate variability in subacute stroke patients: a randomized controlled trial. Int J Rehabil Res. 2022 Sep 1;45(3):201-208. doi: 10.1097/MRR.0000000000000529. Epub 2022 May 2.

    PMID: 35502452DERIVED

  • Mandigout S, Chaparro D, Borel B, Kammoun B, Salle JY, Compagnat M, Daviet JC. Effect of individualized coaching at home on walking capacity in subacute stroke patients: A randomized controlled trial (Ticaa'dom). Ann Phys Rehabil Med. 2021 Jul;64(4):101453. doi: 10.1016/j.rehab.2020.11.001. Epub 2020 Nov 28.

    PMID: 33197648DERIVED

  • Chaparro D, Daviet JC, Borel B, Kammoun B, Salle JY, Tchalla A, Mandigout S. Home-based physical activity incentive and education program in subacute phase of stroke recovery (Ticaa'dom): study protocol for a randomized controlled trial. Trials. 2018 Jan 25;19(1):68. doi: 10.1186/s13063-017-2410-9.

    PMID: 29370824DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2013

First Posted

April 4, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2018

Study Completion

June 1, 2018

Last Updated

August 14, 2018

Record last verified: 2015-03

Locations

FR(1)