Seated Physical Activity in Ageing (SPAA)

July 25, 2019 updated by: University of Birmingham

"Determining the Feasibility of Chair-based Physical Activity Interventions, Aimed at Improving Various Aspects of Health and Wellbeing in Geriatric Populations With Pre-existing Frailty, Within a Hospital Ward Setting"

This trial will take the form of a feasibility study; designed to assess the feasibility of a proposed future clinical trial in this setting. This proposed future clinical trial is proposed to assess the impact of physical activity, in the form of specialised chair based physical activity interventions, on the physiological, psychological, cognitive, social and emotional health, and functional capacity of geriatric populations with pre-existing frailty within a clinical hospital ward setting; recognising health as a holistic concept incorporating a multitude of inter-related dimensions. This feasibility study is single-centre (taking place in the Harborne Ward of the Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston, Birmingham, United Kingdom).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Temporary residents within the Harborne 'living lab' ward of the Queen Elizabeth Hospital Birmingham, Edgbaston, Birmingham, United Kingdom
  • ≥ 65 years of age
  • Frail according to the Fried Frailty criteria: meeting at least three of the five characteristics of frailty (Fried et al. 2001)
  • Have the capacity to speak and read in English
  • Anticipated by their care team to remain on the ward for approximately 14 days post enrolment into the study. This will be advised by the patient's care team.

Exclusion Criteria:

  • Currently taking part in any other clinical trial which could potentially have an impact upon or influences the findings of the current study
  • Currently terminally ill with life expectancy which is less than the duration of the study's interventions
  • Severe sensory impairment which would profoundly impact on their capacity to undergo the interventions, even once appropriate adaptations have been made.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise Intervention 1: Move It Or Lose It (MIOLI)
An established chair-based physical activity programme for older adults.
Other: Exercise Intervention 1: Move It Or Lose It (MIOLI)
An established chair-based physical activity programme for older adults.
Experimental: Exercise Intervention 2: Machine-based resistance training
Specialised, chair-based resistance training equipment for older adults.
Other: Exercise Intervention 2: Machine-based resistance training intervention
Specialised, chair-based, pneumatic resistance training equipment for older adults.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: Post-Intervention (2 weeks)

The primary dependent variable of this feasibility study will relate to the eight primary areas of focus of feasibility studies (Bowen et al. 2009), relating to:

  • Acceptability
  • Demand
  • Implementation
  • Practicality
  • Adaptation
  • Integration
  • Expansion and
  • Limited-efficacy testing

These eight aforementioned areas (constituting the one variable of feasibility) will serve as the primary dependent variable for this study, in order to establish the feasibility of a proposed future clinical trial within this setting. The dependent variable of feasibility will be assessed through semi-structured interviews with participants post intervention, while focus groups will be utilised with both the intervention implementers and study support staff in order to assess the primary dependent variable of the study. Participant uptake and adherence records will also be employed throughout.
Post-Intervention (2 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Cortisol (Physiological Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Serum cortisol : DHEAS ratio (Physiological Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
C-reactive proteins (CRP) (Physiological Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Inflammatory Cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Inflammatory Cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Inflammatory Cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Hand grip strength (Functional Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Leg strength (Functional Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Leg power output (Functional Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Short Physical Performance Battery (SPPB) (Functional Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Fried Frailty Phenotype (Functional Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Geriatric Depression Scale (GDS) (Psychological Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)
Interpersonal Support Evaluation List (ISEL) (Social Dependent Variable)
Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Pre-intervention (baseline), and post-intervention (2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Queen Elizabeth Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Prof. Anna Whittaker, University of Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 9, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 9, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ERN_16-0986S
  • 675003 (Other Grant/Funding Number: European Commission)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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