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FrailtyNCT04045535

Effectiveness of a Physical Activity Intervention for Pre-frail Older Adults With Chronic Pain.

A study testing Physical Activity Program in people with Frailty and Chronic Pain, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Frailty, Chronic Pain, Old Age; Debility
What is being tested?
Physical Activity Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteSpain
Study dates
6 Jun 2018to 2 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Gerencia de Atención Primaria, Madrid

    Madrid, Madrid

Other trials in Spain

About this study

Official title: Effectiveness of a Physical Activity Intervention in the Quality of Life of Pre-frail Older Adults Aged 65 Years or Over With Chronic Pain. Randomized Controlled, Multicenter and Pragmatic Trial in Primary Care.

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.

Read the detailed description

Design: Randomized controlled, pragmatic clinical trial with two groups and 3 months follow-up.

Unit of randomization: Patient. Unit of analysis: Patient. Setting: A Primary Health Care Center in the Spanish Autonomous Community of Madrid.

Population: Pre-frail patients aged 65 years or more with chronic pain. Intervention: Multicomponent structured physical exercise program. Control group: Usual care. Variables: Perceived Health Related Quality of Life (EuroQol 5D-5L), Pain Intensity (Visual Analogue Scale), Frailty (SHARE-Frailty Index), Physical Performance (Short Physical Performance Battery, SPPB), Depression (Yesavage).

Analysis: Mean change differences after 3 months in EQ5D dimensions between groups with CI 95%. Mean differences or proportion differences will be calculated according to variable characteristics between groups with appropriate statistical test.

Being tested
Physical Activity Program, Usual care
Keywords
Primary Health Care, Nursing Intervention, Physical Activity
Medical subject headings
Frailty, Chronic Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Usual careOther

    Usual clinical care based on current clinical practice guidelines.

Study groups in NCT04045535
Study groupRoleWhat they receive
Intervention groupExperimentalIntervention with nurse and patients
Receives: Other: Physical Activity Program; Other: Usual care
Usual careActive comparatorUsual clinical care based on current clinical practice guidelines.
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Change from baseline at 2 and 5 months

Secondary outcomes (8)

  1. Pain Intensity

    Pain Intensity was assessed by McGill Pain Questionnaire's Visual Analog Scale (VAS). It consists on a 100mm horizontal line in which patient points the intensity of his pain. It is measured from left to right. Left side of the line (0 millimeters, mm) means "no pain" and it is the minimum score and right side of the line (100mm) means "pain as worst as you can imagine" and it is maximum score. Lower punctuation meana better outcomes.

    Measured: Change from baseline at 2 and 5 months

  2. Frailty Status

    Frailty Status assessed by SHARE-FI (Survey of Health, Ageing and Retirement Frailty Index). It consists on summarizing the response to 5 criteria (exhaustion, weight loss, weakness, slowness and low active) in a discreet factor (DFS). Scores are different for men and women.

    Women: If predicted DFS < 0.31, NON-FRAIL; If predicted DFS < 2.13, PRE-FRAIL; If predicted DFS < 6, FRAIL Men: If predicted DFS < 1.21, NON-FRAIL; If predicted DFS < 3.00, PRE-FRAIL; If predicted DFS < 7, FRAIL

    Measured: Change from baseline at 2 and 5 months

  3. Physical Performance

    Assessed by Short Physical Performance Battery (SPPB). It evaluates balance, walk speed and sitting and standing in a chair. Each Item is scored 0-4 points. Yielding a total between 0 (worst physical performance ) and 12 (best physical performance).

    Measured: Change from baseline at 2 and 5 months

  4. Falls

    Number of falls during the follow-up process

    Measured: At 2 months and at 5 months

  5. Depression

    Assessed by ultra-short Yesavage Scale (Geriatric Depression Scale, GDS-5). It consist on 5 questions of the GDS-15 questionnaire (Range:0-5. Cutpoint for depression: 2).

    Measured: Change from baseline at 2 and 5 months

  6. Basic Activities of Daily Living (bADL)

    Assessed by Barthel Scale. It assesses the help needed with ten variables: feeding, bathing, grooming, dressing, urinary incontinence, faecal incontinence, toilet use, transfers bed to chair, mobility and climbing stairs. (Range: 0: Full Dependence - 100: Independence for bADL).

    Measured: Change from baseline at 2 and 5 months

  7. Number of meetings attended

    Number of meetings attended by the participants from intervention group.

    Measured: At 2 months

  8. Satisfaction with the intervention

    Assessed with Client Satisfaction Questionnaire (CSQ-8). It consist on 8 questions (four ranged 4: most satisfaction-1: least satisfaction and four ranged 1: most satisfaction -4 least satisfaction)

    Measured: At 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2019
  2. Study start6 Jun 2018
  3. Primary completion2 Jul 2019
  4. Study completion2 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04045535
Sponsor's protocol ID
CT180719
Status last verified
Aug 2019
First submitted
30 Jul 2019
Last updated
7 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33032532

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity Program in people with Frailty and Chronic Pain, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Health Related Quality of Life (time frame: Change from baseline at 2 and 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04045535, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.

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