NCT01622829

Brief Summary

This study tries to improve patient's activity by a "Prescription for Activity" led by physiotherapists in secondary health care setting. Three groups are compared in regard to their increase of physical activity.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

10 months

First QC Date

June 15, 2012

Last Update Submit

June 19, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in levels of physical activity at three months

    overall activity score measured in MET\*h/week assessed by a modified "Recent Physical Activity Questionnaire" (RPAQ) - Change from Baseline in levels of physical activity at 3 months difference

    Baseline, 3 months

Study Arms (3)

group1

EXPERIMENTAL

Usual Physiotherapy, additional: "Prescription for Activity" with a structured fitness program and individual instructions to become more active in the daily living situation

Procedure: "Prescription for Activity" and individual instructions

group 2

EXPERIMENTAL

usual Physiotherapy , additional: "Prescription for Activity" without instructions

Other: "Prescription for Activity", without instructions

group 3

NO INTERVENTION

control, usual physiotherapy

Other: usual physiotherapy

Interventions

Structured education. "Prescription for Activity". This contains an exercise programme which consists of a 30 minutes muscle strengthening exercises to be performed at home at least three times per week and an endurance sports, chosen by the patient, to be performed at least 2 times per week. Additional the physiotherapists advise them in being more active during their individual daily life ( e.g. using a bike for short distances, regular walking, abandon the lift/escalator).

group1

Prescription with exercise programme. "Prescription for activity". This contains an exercise program consisting of 30 minutes of muscle strengthening exercises to be performed at home at least three times per week, the patient also needs to perform in an endurance sport at least two times per week.

group 2

physiotherapy, treatment as usual

group 3

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 40-75 years
  • self-dependent
  • walk around at home alone
  • German-speaking
  • Ability to read and write
  • Life expectancy \> 6 months
  • Stable disease process expected for the next 6 months
  • Time spend in hospital: \> 3 days, \< 4 weeks

You may not qualify if:

  • Patients suffering from dementia
  • Planned participation in rehabilitation
  • severe functional limitations that precluded any increase in physical activity
  • not living independently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Sports Medicine, University of Heidelberg

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

PrescriptionsExercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Pharmaceutical ServicesHealth ServicesHealth Care Facilities Workforce and ServicesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 15, 2012

First Posted

June 19, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2012

Study Completion

September 1, 2013

Last Updated

June 20, 2012

Record last verified: 2012-06

Locations