NCT04045535

Brief Summary

The purpose of this investigation is to evaluate the effectiveness of a multicomponent structured physical exercise program for adults aged 65 years or more, classified as pre-frail and with chronic pain to improve the Perceived Health Related Quality of Life, compared with usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

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

Study Start

First participant enrolled

June 6, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2019

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

July 30, 2019

Last Update Submit

August 4, 2019

Conditions

FrailtyChronic PainOld Age; Debility

Keywords

Primary Health CareNursing InterventionPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Perceived Health Related Quality of Life

    Quality of life assessed by EuroQol 5 Dimen (EQ5D-5L) Scale. It consist on a Quality Index (Range 0-1) calculated from scores of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with value for Spain set and a Visual Analog Scale (Range 0: Worst possible health-100: Best possible health).

    Change from baseline at 2 and 5 months

Secondary Outcomes (8)

  • Pain Intensity

    Change from baseline at 2 and 5 months

  • Frailty Status

    Change from baseline at 2 and 5 months

  • Physical Performance

    Change from baseline at 2 and 5 months

  • Falls

    At 2 months and at 5 months

  • Depression

    Change from baseline at 2 and 5 months

  • +3 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention with nurse and patients

Other: Physical Activity ProgramOther: Usual care

Usual care

ACTIVE COMPARATOR

Usual clinical care based on current clinical practice guidelines.

Other: Usual care

Interventions

Physical Activity ProgramOTHER

Usual Care and a nurse-led physical activity program once a week for 8 weeks. Each session last for 60 minutes, 15 for warming-up and 45 for different exercises.

Intervention group
Usual careOTHER

Usual clinical care based on current clinical practice guidelines.

Intervention groupUsual care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Clinical record of Chronic Pain by International Classification of Primary Care (ICPC) Code A01.
  • Being classified as pre-frail by SHARE-FI questionnaire.
  • Informed consent

You may not qualify if:

  • Housebound patients
  • Institutionalized patients
  • Not living in the area of the investigation
  • Dependence for bADL
  • Not being fluent in Spanish
  • Severe mental illness or cognitive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerencia de Atención Primaria, Madrid

Madrid, Madrid, Spain

Location

Related Publications (1)

  • Otones P, Garcia E, Sanz T, Pedraz A. A physical activity program versus usual care in the management of quality of life for pre-frail older adults with chronic pain: randomized controlled trial. BMC Geriatr. 2020 Oct 8;20(1):396. doi: 10.1186/s12877-020-01805-3.

    PMID: 33032532DERIVED

MeSH Terms

Conditions

FrailtyChronic PainMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsBehavior

Study Officials

  • Pedro Otones Reyes, RN, PhDc

    Gerencia de Atención Primaria, Madrid

    PRINCIPAL INVESTIGATOR

  • Eva García Perea, RN, PhD

    Universidad Autonoma de Madrid

    STUDY DIRECTOR

  • Azucena Pedraz Marcos, RN, PhD

    Universidad Autonoma de Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Intervention can't be masked. Statistician conducting the analysis will not know to which study arm a given patient has been assigned.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator. Cinical nurse

Study Record Dates

First Submitted

July 30, 2019

First Posted

August 5, 2019

Study Start

June 6, 2018

Primary Completion

July 2, 2019

Study Completion

July 2, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)