NCT02605980

Brief Summary

United Kingdom (UK) physical activity guidelines for older people state that "All older adults should minimise the amount of time spent being sedentary (sitting) for extended periods" and "there is sufficient evidence to support a recommendation to reduce sedentary behaviour in older adults, but it is not currently possible to suggest a specific time limit." The aim of this study is to identify key physiological and psychological outcomes influenced by acute periods of inactivity and what older people feel after these acute periods of inactivity. The investigators' main objective is to determine, through direct measurement and self report, the acute functional and cognitive effects of differing periods of sitting time. A secondary objective is to inform older people, professionals and organisations working with older people and policy makers on what duration of sedentary behaviour will lead to adverse outcomes in older people. The investigators will recruit ambulatory men and women aged 70 y and over who will be studied on three separate occasions, approximately one week apart to complete sedentary bouts of 1 h, 2 h and 4 h in a randomised crossover design. The investigators will explore the relationship between sitting time and changes in lower limb explosive power(primary outcome) measured before and after each bout. Secondary outcomes will include timed chair rise; Timed Up and Go; blood pressure; perception of musculoskeletal comfort/pain, vitality; mood and cognitive function. The investigators will also measure the stress hormone cortisol in samples of saliva taken at the start of the sitting session, 1 h, 2h and 4 h later. Characterising the acute effects of sitting time in older adults will enable the design of interventions to reduce sedentary time as well as inform professionals and policy makers on what duration of sedentary behaviour will lead to adverse outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

March 2, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

June 11, 2019

Status Verified

March 1, 2016

Enrollment Period

2.7 years

First QC Date

October 16, 2015

Last Update Submit

June 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in lower limb extensor power (Nottingham Power Rig)

    The design of the device includes an adjustable seat and a footplate connected through a chain and lever to a flywheel. There is an attached seat which is adjustable to the appropriate position for each participant, ensuring that when the footplate is fully depressed, the participant's leg will be in the extended position. The participant will sit upright in the seat with arms crossed across the chest and non- dominant leg resting with the foot flat on the floor or frame of the rig. The participants will be required to apply maximal force to the footplate, by extending their dominant leg with maximal effort. When force is applied to the footplate, the flywheel accelerates, initiating the data collection. The final velocity of the flywheel will be used to calculate power (W.kg-1), which will then be displayed on a computer interface.

    This will be assessed seven times within a period of six weeks throughout the study. First will be at the start of study (first visit).Two more tests will be conducted each time on the second,third and final visits which will be one week apart.

Secondary Outcomes (13)

  • Change in Timed chair rise (functional ability)

    This will be assessed seven times across three sessions (one week apart) over a period of six weeks throughout the study i.e.at the start of study, and two more tests each time on the second,third and final visits.

  • Change in Timed Up and Go (marker of falls risk)

    This measure will be assessed seven times across three sessions (one week apart) over a period of six weeks throughout the study period.

  • Change in blood pressure (postural hypotension)

    Blood pressure will be recorded seven times across three sessions (one week apart) over a period of six weeks throughout the study period.

  • Change in balance (postural sway)

    Postural sway as a measure of static balance will be assessed seven times across three sessions (one week apart) over a period of six weeks throughout the study.

  • Change in salivary cortisol

    Salivary samples will be collected nine times across three sessions (one week apart) over a period of six weeks to measure cortisol levels in participants.

  • +8 more secondary outcomes

Study Arms (2)

Male

Community-dwelling healthy older adults over the age of 70 years. Must be ambulatory, with or without walking aids

Behavioral: Sedentary time

Female

Community-dwelling healthy older adults over the age of 70 years. Must be ambulatory, with or without walking aids

Behavioral: Sedentary time

Interventions

Sedentary timeBEHAVIORAL
FemaleMale

Eligibility Criteria

Age70 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community-dwelling healthy older adults aged 70 years or over. Must be ambulatory with or without a walking aid.

You may qualify if:

  • years or over
  • Ambulatory with or without a walking aid.

You may not qualify if:

  • History of myocardial infarction within previous 2 years
  • Cardiac illness: moderate/ severe aortic stenosis, acute pericarditis, acute myocarditis, aneurysm, severe angina, clinically significant valvular disease, uncontrolled dysrhythmia, claudication within the previous 10 years
  • Thrombophlebitis or pulmonary embolus within the previous 2 years
  • History of cerebrovascular disease (CVA or TIA) within the previous 2 years
  • Acute febrile illness within the previous 3 months
  • Severe airflow obstruction
  • Uncontrolled metabolic disease (e.g., thyroid disease or cancer)
  • Significant emotional distress, psychotic illness or depression within the previous 2 years
  • Lower limb fracture sustained within the previous 2 years; upper limb fracture within the previous 6 months; non arthroscopic lower limb joint surgery within the previous 2 years
  • Any reason for loss of mobility for greater than 1 week in the previous 2 months or greater than 2 weeks in the previous 6 months
  • Poorly controlled atrial fibrillation
  • Poor (chronic) pain control
  • Resting systolic pressure \>200 mmHg or resting diastolic pressure \>100 mmHg
  • Moderate/ severe cognitive impairment (MMSE \<23)
  • Impaired tissue viability (defined by a Waterlow risk assessment score \>15).
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Birmingham

Birmingham, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and serum from living donors

Study Officials

  • Carolyn A Greig, PhD

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2015

First Posted

November 17, 2015

Study Start

March 2, 2016

Primary Completion

November 26, 2018

Study Completion

December 31, 2018

Last Updated

June 11, 2019

Record last verified: 2016-03

Locations