NCT03450655

Brief Summary

Given the increasing prevalence of obesity, there is an urgent need to find better strategies to promote physical activity in the community. The present study will invite 70-year-olds with central (abdominal) obesity to participate in a 10-week aerobic exercise program. Participants will be randomly assigned to one of two equally large groups. The first group will complete the exercise program in instructor-led groups. The second group will complete the program at home with the help of an on-line video.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 9, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2018

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

February 16, 2018

Last Update Submit

February 28, 2018

Conditions

Visceral Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in visceral adipose tissue mass

    Mass (g) measured using Lunar iDXA with CoreScan application (GE Healthcare, Wauwatosa, WI, USA).

    0, 10, 20, and 31 weeks

Secondary Outcomes (13)

  • Change in body composition

    0, 10, 20, and 31 weeks

  • Change in Body Mass Index (kg/m^2)

    0, 10, 20, and 31 weeks

  • Change in blood pressure (mmHg)

    0, 10, 20, and 31 weeks

  • Change in blood-lipid profile

    0, 10, 20, and 31 weeks

  • Change in fasting blood glucose

    0, 10, 20, and 31 weeks

  • +8 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Weeks 1-10: exercise program in group. Weeks 11-20: no intervention. Weeks 21-31: no intervention.

Other: 10-week aerobic exercise program

Control group

EXPERIMENTAL

Weeks 1-10: no intervention. Weeks 11-20: no intervention. Weeks 21-31: exercise program at home.

Other: 10-week aerobic exercise program

Interventions

10-week aerobic exercise programOTHER

An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.

Control groupIntervention Group

Eligibility Criteria

Age70 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Participated in the Healthy Ageing Initiative (a population-based intervention study in Umeå, Sweden)
  • Visceral adipose tissue mass \>1 kg (women) or \>2 kg (men)

You may not qualify if:

  • Physical disability that affects ability to perform the exercises
  • Heart failure or severe degenerative condition (e.g. malignant cancer or multiple sclerosis)
  • Myocardial infarction or stroke in the past year
  • Heart condition that can worsen with aerobic exercise (e.g. angina)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Livsmedicin (LIFE)

Umeå, Västerbotten County, 907 36, Sweden

Location

Related Publications (3)

  • Ballin M, Hult A, Bjork S, Lundberg E, Nordstrom P, Nordstrom A. Web-based exercise versus supervised exercise for decreasing visceral adipose tissue in older adults with central obesity: a randomized controlled trial. BMC Geriatr. 2020 May 12;20(1):173. doi: 10.1186/s12877-020-01577-w.

    PMID: 32398024DERIVED

  • Ballin M, Lundberg E, Sorlen N, Nordstrom P, Hult A, Nordstrom A. Effects of interval training on quality of life and cardiometabolic risk markers in older adults: a randomized controlled trial. Clin Interv Aging. 2019 Sep 4;14:1589-1599. doi: 10.2147/CIA.S213133. eCollection 2019.

    PMID: 31564841DERIVED

  • Ballin M, Lundberg E, Sorlen N, Nordstrom P, Hult A, Nordstrom A. Effects of Interval Training on Visceral Adipose Tissue in Centrally Obese 70-Year-Old Individuals: A Randomized Controlled Trial. J Am Geriatr Soc. 2019 Aug;67(8):1625-1631. doi: 10.1111/jgs.15919. Epub 2019 Apr 23.

    PMID: 31012497DERIVED

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anna Nordström, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The Data Analyst will also be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

February 16, 2018

First Posted

March 1, 2018

Study Start

February 9, 2018

Primary Completion

September 28, 2018

Study Completion

September 28, 2018

Last Updated

March 1, 2018

Record last verified: 2018-02

Locations

SE(1)