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Exercise Adherence in Afghan Women With Depression

2026년 8월 3일 업데이트: Nommanudien Naibkhil, Ariana Medical Complex

A Randomized Controlled Trial Comparing Exercise Adherence Between a Structured Culturally Adapted Home-Based Exercise Program and Routine Exercise Advice Among Afghan Women With Depression

The goal of this clinical trial is to learn whether a structured, culturally adapted home-based exercise program helps Afghan women with depression stay more active than routine exercise advice. The study will also examine whether taking part in the exercise program improves depression symptoms, daily functioning, and participant satisfaction, and whether the program is safe.

The main questions the study aims to answer are:

  • Does a structured home-based exercise program help participants exercise more regularly over 8 weeks?
  • Does the program improve depression symptoms and daily functioning?
  • Is the program acceptable to participants, and are there any safety concerns?

Researchers will compare a structured home-based exercise program with routine exercise advice to see which approach leads to better exercise adherence.

About 60 women aged 18 to 50 years with mild to moderate depression will take part. Participants will be randomly assigned (by chance) to one of two groups.

Participants in the structured exercise group will:

  • Receive an illustrated exercise booklet with simple home-based exercises, such as breathing, stretching, walking, and light aerobic activities.
  • Choose exercises that suit their preferences, abilities, and daily schedules.
  • Record each exercise session in a logbook, including the date, type of exercise, and how long they exercised.

Participants in the routine exercise advice group will:

  • Receive their usual psychiatric care and general advice about the benefits of physical activity.
  • Receive a logbook to record any physical activity or exercise they complete during the study.

All participants will take part in the study for 8 weeks. At the beginning and end of the study, they will complete questionnaires about their depression symptoms and their ability to carry out everyday activities. At the end of the study, participants will also complete a questionnaire about their satisfaction with the program, and researchers will ask about any medical problems or injuries that occurred during the study.

The information from this study may help researchers understand whether a culturally adapted home-based structured exercise program is a practical and effective way to support Afghan women with depression and encourage regular physical activity.

연구 개요

상세 설명

Depression is one of the most common mental health disorders worldwide and is a leading cause of disability. Women are affected more frequently than men and often experience substantial impairment in emotional well-being, family life, social participation, and daily functioning. In Afghanistan, women may face additional challenges that increase their risk of depression, including prolonged exposure to conflict, financial hardship, caregiving responsibilities, social restrictions, current political restrictions, and limited access to mental health services. In addition, current restrictions imposed by the de facto authorities prohibit women from accessing public parks and gyms, substantially limiting opportunities for outdoor and facility-based physical activity. As a result, many women have few opportunities to engage in regular exercise despite its recognised benefits for both physical and mental health.

Regular physical activity has been shown to improve depressive symptoms and overall well-being. Proposed mechanisms include improvements in neurotransmitter function, reduction of stress-related physiological responses, enhancement of neuroplasticity, and positive psychological effects such as improved self-efficacy, mood, and quality of life. Exercise is therefore widely recommended as an adjunct to standard treatment for mild and moderate depression.

Although the benefits of exercise are well established, maintaining regular participation remains a major challenge. Many people begin exercising but discontinue after a short period because of motivational, environmental, cultural, or practical barriers. For Afghan women, these barriers may be particularly important. Opportunities to participate in organised exercise programmes are limited, and access to women-only fitness facilities is restricted. Cultural expectations, household responsibilities, concerns about privacy and modesty, transportation difficulties, and limited safe outdoor environments may further reduce participation in physical activity.

Home-based exercise programmes may provide a practical alternative by allowing women to exercise in a familiar and culturally acceptable environment without requiring specialised facilities or equipment. However, simply advising people to exercise may not be sufficient to encourage sustained participation. Programmes that provide clear instructions, culturally appropriate educational materials, and structured support may help improve adherence by increasing confidence, reducing uncertainty, and making exercise easier to incorporate into everyday life.

Despite growing international evidence supporting exercise as part of depression management, little research has examined culturally adapted home-based exercise interventions among Afghan women. Furthermore, limited evidence exists regarding exercise adherence in this population. Understanding whether a culturally appropriate programme improves adherence is important because the effectiveness of exercise depends largely on participants' ability and willingness to continue exercising over time.

This pilot randomised controlled trial has been designed to evaluate the feasibility and preliminary effectiveness of a structured culturally adapted home-based exercise programme for Afghan women with mild to moderate depression receiving outpatient psychiatric care. The study will compare this structured approach with routine exercise advice delivered as part of usual clinical care. The primary focus is to determine whether providing a culturally tailored exercise programme improves adherence to physical activity over an eight-week period.

In addition to evaluating exercise adherence, the study will explore whether greater participation in physical activity is associated with improvements in depressive symptoms, functional status, participant satisfaction, and the overall acceptability of the intervention. Information regarding adverse events occurring during participation will also be collected to better understand the safety of implementing a home-based exercise programme in this population.

The intervention has been developed to reflect the cultural and practical circumstances of Afghan women. The programme consists of illustrated guidance for home-based exercises that can be performed without specialised equipment and can be adapted to individual physical ability and available time. This flexible approach is intended to improve long-term engagement while respecting individual differences in daily responsibilities, physical fitness, and health status.

The study also seeks to generate preliminary data that may support the planning of future larger-scale clinical trials. As no previous randomised studies have specifically investigated culturally adapted home-based exercise adherence among Afghan women with depression, information from this pilot study will help estimate adherence rates, assess study feasibility, identify implementation challenges, and inform sample size calculations for future definitive research.

If the structured home-based exercise programme demonstrates improved adherence and favourable clinical outcomes, it could provide a practical, low-cost, and culturally appropriate strategy for integrating physical activity into routine mental health care for women with depression in Afghanistan. Because the intervention requires minimal resources and can be delivered without specialised exercise facilities, it may also be suitable for implementation in other low-resource or culturally similar settings where access to supervised exercise programmes is limited.

The findings of this study are expected to contribute to the limited evidence on behavioural interventions for depression in Afghanistan and may support the development of culturally appropriate, non-pharmacological approaches that complement existing psychiatric care. The results may also help healthcare providers and policymakers better understand how structured home-based physical activity programmes can be incorporated into comprehensive depression management within resource-constrained healthcare systems.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Nommanudien Naibkhil, Pharm. D.
  • 전화번호: +93786785956
  • 이메일: n.naibkhil@gmail.com

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Female participants who self-identify as women.
  • Age 18 to 50 years.
  • Able to read and understand the study information (at least school graduate).
  • Diagnosis of mild to moderate depression according to DSM-5 criteria.
  • Medically able to participate in moderate physical activity.
  • Willing to participate in the study and provide written informed consent.

Exclusion Criteria:

  • Severe depression requiring hospitalization.
  • Psychotic disorders.
  • Bipolar disorder.
  • Severe cardiovascular disease or respiratory disease limiting exercise participation.
  • Musculoskeletal conditions preventing participation in exercise.
  • Pregnancy-related conditions restricting physical activity.
  • Cognitive impairment affecting the ability to provide informed consent.
  • Regular exercise habits before enrolment.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Structured Culturally Adapted Home-Based Exercise Program
Participants assigned to this arm will receive usual psychiatric care plus a structured, culturally adapted home-based exercise program. The intervention includes an illustrated exercise booklet containing breathing, stretching, walking, and light-to-moderate aerobic exercises that can be performed safely at home without specialised equipment. Participants will receive initial visual instruction on performing the exercises and will be encouraged to choose exercises according to their preferences, physical abilities, and available time during the 8-week study period. Participants will record each exercise session in a logbook to monitor exercise adherence.
Participants will receive a structured, culturally adapted home-based exercise program in addition to usual psychiatric care. The intervention includes an illustrated exercise booklet containing breathing, stretching, indoor walking, brisk walking (where feasible), and light-to-moderate aerobic exercises that can be performed at home without specialised equipment. Participants will receive an initial face-to-face training session on how to perform the exercises safely and correctly. They will be encouraged to select exercises according to their preferences, physical abilities, and available time over the 8-week study period. An exercise logbook will be provided to record the date, type, and duration of each exercise session for adherence monitoring.
활성 비교기: Routine Exercise Advice
Participants assigned to this arm will receive usual psychiatric care and routine advice on the benefits of physical activity, including general recommendations such as walking and household physical activities. They will not receive the structured home-based exercise program, illustrated exercise booklet, or exercise instruction provided to the experimental group. Participants will receive an exercise logbook to record any physical activity or exercise performed during the 8-week study period, allowing comparison of exercise adherence between the study groups.
Participants will receive usual psychiatric care and routine verbal advice on the benefits of physical activity, including general recommendations such as walking and household physical activities. No structured exercise program, illustrated exercise booklet, supervised exercise instruction, or scheduled exercise follow-up will be provided. Participants will receive an exercise logbook to record any physical activity or exercise performed during the 8-week study period to allow assessment of exercise adherence.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Exercise adherence
기간: Baseline to Week 8 (8 weeks)

Primary Outcome Measure 1: Exercise adherence - Total exercise sessions completed.

Exercise adherence will be measured as the total number of exercise sessions of at least 30 minutes' duration completed during the 8-week intervention, as recorded in participant-completed exercise logbooks.

Baseline to Week 8 (8 weeks)

2차 결과 측정

결과 측정
측정값 설명
기간
Total Exercise Duration
기간: 8 weeks

Total exercise duration will be measured as the cumulative number of minutes of exercise completed during the 8-week intervention, as recorded in participant-completed exercise logbooks.

The primary comparison will evaluate whether participants receiving the structured culturally adapted home-based exercise program demonstrate greater exercise adherence than participants receiving routine exercise advice.

8 weeks
Depression Severity
기간: 8 weeks

Depression severity will be measured using the Hamilton Depression Rating Scale (HDRS).

HDRS assessments will be conducted at:

  • Baseline (Week 0)
  • End of intervention (Week 8) The change in HDRS score will be calculated as the difference between baseline and Week 8 scores.

The study will compare:

  • Within-group changes from baseline to Week 8.
  • Differences in improvement between intervention groups. Change in HDRS score = Baseline HDRS score - Week 8 HDRS score Higher positive values indicate greater improvement in depressive symptoms.
8 weeks
Functional Status
기간: 8 weeks

Functional status will be assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), 12-item version.

WHODAS 2.0 assessments will be completed at:

  • Baseline (Week 0)
  • End of intervention (Week 8) Changes in functional status will be evaluated by comparing WHODAS 2.0 scores before and after the intervention.

Change in WHODAS 2.0 score = Baseline Score - Week 8 score Higher positive values indicate greater improvement in functioning and reduction in disability.

Mean changes in WHODAS 2.0 scores will be compared:

  • Within each group (baseline versus Week 8)
  • Between the intervention and control groups after 8 weeks
8 weeks
Participant Satisfaction
기간: 8 weeks

Participant satisfaction with the assigned intervention will be assessed using a structured satisfaction questionnaire developed for the study.

The questionnaire will assess participants' perceptions regarding:

  • Ease of participation
  • Acceptability of the intervention
  • Perceived usefulness of the intervention
  • Willingness to continue exercising after study completion
  • Overall satisfaction with the intervention Responses will be collected using a Likert-scale format, and overall satisfaction scores will be summarized and compared between study groups.

Mean satisfaction scores and the distribution of responses will be summarized using descriptive statistics and compared between groups where appropriate.

8 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Pazhman Sediqi, Neurologist, Ariana Medical Complex
  • 수석 연구원: Sodaba Rahraw, MD, Ariana Medical Complex
  • 연구 의자: Nommanudien Naibkhil, Pharm. D., Ariana Medical Complex

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2026년 11월 1일

연구 완료 (추정된)

2026년 11월 30일

연구 등록 날짜

최초 제출

2026년 7월 27일

QC 기준을 충족하는 최초 제출

2026년 8월 3일

처음 게시됨 (실제)

2026년 8월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 3일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data (IPD) will not be shared with other researchers. Study data will be maintained securely by the research team, and access will be limited to authorized study personnel to protect participant confidentiality. De-identified aggregate results may be reported in scientific publications and presentations.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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