Effects of a Blended Indoor and Outdoor Physical Exercise Program on Depressive Symptoms in Hong Kong Older Adults

December 19, 2023 updated by: Hong Kong Baptist University

Effects of a Blended Indoor and Outdoor Physical Exercise Program on Depressive Symptoms in Hong Kong Older Adults: a Randomized Controlled Trial

Depression is a mental health problem often occurring in the elderly. Performing physical exercise is a key element in decreasing depressive symptoms in older adults. Most studies investigating depression and physical exercise have focused on structured exercise comprise of one or two exercise components and based on the clinical patients associated with major depression. There is limited research combining multicomponent (aerobic+resistance+balance) in an exercise program and targeting non-clinical adults with depressive symptoms, with even less available for older adults.

More attention has been paid to the role of outdoor exercise on human health. Exercise in a natural environment may provide greater physiological and psychological benefits compared to indoor exercise. Findings demonstrated that green exercise provides double the beneficial effect on improving depression among adults. Although green exercise shows effects on the improvement of depression, recently a review has indicated that structured exercise programs in older adults with depressive symptoms were mainly conducted in the indoor environment. Compared with outdoor exercise which is easily influenced by the weather and with low access of available facilities, indoor exercise is more comfortable, quiet, and convenient to operate especially for older adults. Considering the high relevance between nature and mental health, the combination of indoor and outdoor exercise programs might be able to maximize intervention effectiveness while maintaining the benefits for each type of intervention.Therefore, more rigorous RCT studies in this field are needed, particularly for non-clinical older adults with depressive symptoms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The 16-week double-blinded RCT (2 sessions/week, 90 min/session) will include community-dwelling older adults aged 60 to 74 years old with depressive symptoms. Participants will be randomized to one of three groups (a blended indoor and outdoor group, an indoor-only group or a control group) using 1:1:1 allocation ratio. Structured exercise training with multicomponent (aerobic, muscle strength, balance) will be conducted in two intervention groups. The intervention effects will be evaluated on depressive symptoms, physical fitness, physical activity enjoyment and connectedness to nature. All measured data will be collected at the pre-intervention, post-intervention, and 3-month follow up stages.

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • 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 Locations

  • Hong Kong
      • Kowloon Bay, Hong Kong
        • Recruiting
        • Bliss District Elderly Community Centre

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 60 to 74 years at the start date of the project.
  • Chinese version of Geriatric Depression Scale (GDS-C) scoring 5-15 (i.e., mild to serve level of depressive symptoms).
  • Passing the PAR-Q plus screening or with the physician's approval for readiness to participate in high-intensity exercise.

Exclusion Criteria:

  • Having cognition impairment regarded by specialists.
  • are attending other health projects related to physical exercise.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: blended indoor and outdoor multicomponent structured exercise group
Participants will receive a 16-week blended indoor and outdoor multicomponent structured exercise program, with 2 sessions per week (90 mins/session).
Behavioral: Blended indoor and outdoor multicomponent structured exercise
Participants will receive a 16-week blended indoor and outdoor multicomponent structured exercise program, with 2 sessions per week (90 mins/session). Session 1/week will conduct in indoor setting, while session 2/week will conducted in outdoor setting (park). Each session will comprise 10-min warm-up, 30-min aerobic training, 20-min muscle strength, 20-min postural balance training, and 10-min cool-down.
Active Comparator: indoor-only multicomponent structured exercise group
Participants will receive a 16-week indoor-only multicomponent structured exercise program, with 2 sessions per week (90 mins/session).
Behavioral: Indoor-only multicomponent structured exercise
Participants will receive a 16-week indoor-only multicomponent structured exercise program, with 2 sessions per week (90 mins/session). Both two sessions will conducted in indoor setting. Each session will comprise 10-min warm-up, 30-min aerobic training, 20-min muscle strength, 20-min postural balance training, and 10-min cool-down.
No Intervention: control group
The control group will not receive any intervention during the whole project.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported depressive symptoms
Time Frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
The Chinese version of the 15-item Geriatric Depression Scale (GDS-C) will be used to measure the subjective depression level. The GDS are the most widely used scales for the detection of depression symptoms in older adults (Cronbach's α = .81 -.83).
Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
Concentration of saliva cortisol
Time Frame: Evaluations of concentration of saliva cortisol will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
Objective biomarker of depression will be measured in salivary cortisol. All participants will be provided with three salivette tubes and be asked to collect the saliva samples (2-3 ml) at awakening and 30 mins after awakening, respectively. All saliva samples for all subjects will be collected at the same time of day and samples will not be taken on days in which participants are sick with a fever. The salivette tubes will be stored in the freezer zone until to be tested. ELISA KIT protocol will be used to be followed to collect and analyze the samples in each assessment.
Evaluations of concentration of saliva cortisol will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical fitness
Time Frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
Physical fitness will be assessed using the Senior Fitness Test (SFT) battery. There are seven testing items measuring all five dimensions, including the body mass index (BMI), 30s chair stand for lower limbs' muscle strength, 30s arm curl for upper limbs' muscle strength, 2-min step test for aerobic endurance, chair sit-and-reach test for lower body flexibility, back scratch test for upper body flexibility, and 8ft up-and-go test for mobility and dynamic balance.
Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
Loneliness
Time Frame: Evaluations of concentration of saliva cortisol will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
The 6-item De Jong Gierveld Loneliness Scale with Chinese version will be applied for assessing loneliness. This scale has been shown a sound reliability and validity for older adults in Hong Kong (Cronbach's alpha=0.76). Item 1 to item 3 as negatively worded items will be measured "emotional loneliness", answer "yes" will score 1, answer "more or less" will score 1, answer "no" will score 0. Item 4 to item 6 as positively worded items will be used to assessed "social loneliness", answer "yes" will score 0, answer "more or less" will score 1, answer "no" will score 1.
Evaluations of concentration of saliva cortisol will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
Physical activity enjoyment
Time Frame: Evaluations of concentration of saliva cortisol will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
The Chinese version of the 8-item physical activity enjoyment scale (PACES) will be measured participant's enjoyment level after engaging in blended indoor and outdoor multicomponent exercise program. This scale has revealed strong internal consistency and reliability among Hong Kong older adults (Cronbach's alpha=0.92). It will be scored by 7 bipolar rating, from one extreme to the other extreme, for example, from "it's very pleasant" to "it's very unpleasant".
Evaluations of concentration of saliva cortisol will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
Connectedness to nature
Time Frame: Evaluations of concentration of saliva cortisol will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
The 14-item connectedness to nature scale (CNS) with Chinese version will be used to measure the sense of belonging to the natural world. This five-point scale, ranging from 1 "strongly disagree" to 5 "strongly agree".
Evaluations of concentration of saliva cortisol will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported Rate of Perceived Exertion (RPE)
Time Frame: RPE will be asked at the end of main exercise at each exercise session during the 16-weeks intervention.
Older adults will be asked about the self-reported Rate of Perceived Exertion (RPE Borg CR-10 category scale) after they complete the main exercise training in each session.
RPE will be asked at the end of main exercise at each exercise session during the 16-weeks intervention.
Process evaluation of intervention program
Time Frame: Outcome evaluations will be conducted at the completion of 16-weeks intervention.
A process evaluation scale of the intervention process will be developed for this study based on the previous framework of process evaluation for the intervention study. This scale with 10 items using a 5-point (strongly unsatisfied, unsatisfied, neutral, satisfied, and strongly satisfied). The score on this scale ranges from 10 to 50, a higher score shows higher satisfaction with the intervention program.
Outcome evaluations will be conducted at the completion of 16-weeks intervention.

Collaborators and Investigators

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

Sponsor

Hong Kong Baptist University

Investigators

  • Principal Investigator: Yanping Duan, P.hD, Hong Kong Baptist Univeristy; Department of Sport, Physical Education and Health

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

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)

April 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

November 3, 2024

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05200098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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